Drugs / Axicabtagene Ciloleucel
Regulatory milestones approvals, filings & regulatory actions · 9 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed aggressive B-cell non-Hodgkin lymphoma 1 milestone | |||||
| Filed | US (FDA) | — | aggressive B-cell non-Hodgkin lymphoma | 2017-03-31 | “On March 31, 2017 , Kite submitted a Biologics License Application to the FDA for its lead product candidate, axicabtagene ciloleucel (axi-cel)” gilead.com ↗ “Kite completed its submission of a Biologics License Application (BLA) for axicabtagene ciloleucel with the FDA in March 2017” gilead.com ↗ |
| Filed diffuse large B-cell lymphoma 1 milestone | |||||
| Filed | EU (EMA) | — | diffuse large B-cell lymphoma | — | “A Marketing Authorization Application (MAA) for axicabtagene ciloleucel is currently under review with the European Medicines Agency (EMA)” kitepharma.com ↗ |
| Filed follicular lymphoma, susceptibility to 2 milestones | |||||
| Filed | US (FDA) | Yescarta | follicular lymphoma, susceptibility to | 2020-12-05 | “the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA)” gilead.com ↗ |
| Filed | EU (EMA) | Yescarta | follicular lymphoma, susceptibility to | — | “Yescarta is currently under review in the European Union for the treatment of adult patients with relapsed or refractory FL.” gilead.com ↗ |
| Filed high grade B-cell lymphoma with MYC and/ or BCL2 and/or BCL6 rearrangement 1 milestone | |||||
| Filed | EU (EMA) | — | high grade B-cell lymphoma with MYC and/ or BCL2 and/or BCL6 rearrangement | 2017-07-31 | “Submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for axi-cel as a treatment for patients with relapsed/refractory diffuse large B-cell...” gilead.com ↗ “today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for axicabtagene ciloleucel” gilead.com ↗ “A marketing authorization application (MAA) has also been filed for axi-cel for the treatment of relapsed/refractory DLBCL, TFL and PMBCL” gilead.com ↗ “Kite filed a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for axicabtagene ciloleucel in July 2017” gilead.com ↗ |
| Filed large B-cell lymphoma 3 milestones | |||||
| Filed | US (FDA) | Yescarta | large B-cell lymphoma | 2021-09-30 | “today announced that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Yescarta®” gilead.com ↗ “under review in the U.S. and European Union for use as an earlier treatment of adult patients with second-line relapsed or refractory LBCL.” gilead.com ↗ |
| Filed | China (NMPA) | — | large B-cell lymphoma | 2020-02-24 | “NDA filing for CD19-directed CAR-T cell therapy Axicabtagene Ciloleucel (FKC876) has been accepted for review by China National Medical Products Administration (NMPA)” fosunpharma.com ↗ |
| Filed | EU (EMA) | Yescarta | large B-cell lymphoma | — | “under review in the U.S. and European Union for use as an earlier treatment of adult patients with second-line relapsed or refractory LBCL.” gilead.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Yescarta | — | 2018-08-23 | europa.eu ↗ |
Trials 35
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07606937 | Jun → Nov 2026 expected | aggressive B-cell non-Hodgkin lymphoma | Shenzhen Fosun Kairos Biotechnology Co., Ltd. | Recruiting | No outcome recorded |
| Phase 15 trials | ||||||
| Phase 1 | NCT05077527 | Feb 2025 → Jan 2028 expected | HIV infectious disease, high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma | AIDS Malignancy Consortium | Recruiting | No outcome recorded |
| Phase 1 | NCT05794958 | May 2023 → Apr 2038 expected | large B-cell lymphoma, non-Hodgkin lymphoma | Stanford University | Recruiting | No outcome recorded |
| Phase 1 | NCT04608487 | Dec 2020 → Jun 2025 overdue | lymphoma | Dana-Farber Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04314843 | May 2020 → Mar 2021 | aggressive B-cell non-Hodgkin lymphoma | Kite, A Gilead Company | Terminated | No outcome recorded |
| Phase 1 | NCT03704298 | Nov 2018 → May 2021 | aggressive B-cell non-Hodgkin lymphoma | Kite, A Gilead Company | Terminated | No outcome recorded |
| Phase 1/24 trials · 1 met primary | ||||||
| Phase 1/2 | NCT06902012 | Feb 2027 → Feb 2028 expected | diffuse large B-cell lymphoma | Zhujiang Hospital | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04257578 | Dec 2020 → Aug 2025 overdue | high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma | University of Washington | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02926833 | Sep 2016 → Jan 2023 | diffuse large B-cell lymphoma | Kite, A Gilead Company | Completed | No outcome recorded |
| Phase 1/2 | NCT02348216 | Apr 2015 → Jul 2023 | follicular lymphoma, high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma | Kite, A Gilead Company | Completed | Met primary |
| Phase 215 trials · 2 met primary · 1 missed | ||||||
| Phase 2 | NCT07538635 | Apr 2026 → Feb 2028 expected | aggressive B-cell non-Hodgkin lymphoma | Zhejiang Cancer Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07326371 | Mar 2026 → Jul 2027 expected | diffuse large B-cell lymphoma | Ruijin Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06912529 | Mar → Jul 2025 | B-cell non-Hodgkin lymphoma | University of Münster | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT06826118 | Feb 2025 → Dec 2026 expected | follicular lymphoma | The First Affiliated Hospital of Xiamen University | Recruiting | No outcome recorded |
| Phase 2 | NCT07254754 | Nov 2024 → Jan 2027 expected | diffuse large B-cell lymphoma | Spanish Lymphoma Cooperative Group | Recruiting | No outcome recorded |
| Phase 2 | NCT06043323 | Jan 2024 → Sep 2028 expected | follicular lymphoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05459571 | Aug 2022 → Nov 2025 | large B-cell lymphoma | Kite, A Gilead Company | Completed | No outcome recorded |
| Phase 2 | NCT04531046 | Mar 2021 → Apr 2022 overdue | B-cell non-Hodgkin lymphoma | The Lymphoma Academic Research Organisation | Active not recruiting | Met primary |
| Phase 2 | NCT04150913 | Oct 2020 → Oct 2023 | cytokine release syndrome, non-Hodgkin lymphoma | Massachusetts General Hospital | Completed | Missed primary |
| Phase 2 | NCT04432506 | Jul 2020 → May 2024 | high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT04002401 | Nov 2019 → Jan 2023 | large B-cell lymphoma | Kite, A Gilead Company | Completed | No outcome recorded |
| Phase 2 | NCT03761056 | Jan 2019 → Oct 2023 | large B-cell lymphoma | Kite, A Gilead Company | Completed | No outcome recorded |
| Phase 2 | NCT03642626 | Dec 2018 → Feb 2024 overdue | acute lymphoblastic leukemia, large B-cell lymphoma | Masonic Cancer Center, University of Minnesota | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03105336 | Jun 2017 → Dec 2024 | follicular lymphoma, marginal zone lymphoma | Kite, A Gilead Company | Completed | No outcome recorded |
| Phase 2 | NCT02601313 | Nov 2015 → Sep 2023 | mantle cell lymphoma | Kite, A Gilead Company | Completed | Met primary |
| Phase 34 trials · 1 met primary | ||||||
| Phase 3 | NCT07479797 | May 2026 → May 2031 expected | large B-cell lymphoma | Kite, A Gilead Company | Recruiting | No outcome recorded |
| Phase 3 | NCT05605899 | Feb 2023 → Mar 2031 expected | large B-cell lymphoma | Kite, A Gilead Company | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05371093 | Sep 2022 → Oct 2030 expected | lymphoma | Kite, A Gilead Company | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03391466 | Jan 2018 → Mar 2021 | diffuse large B-cell lymphoma | Kite, A Gilead Company | Completed | Met primary |
| Phase 42 trials | ||||||
| Phase 4 | NCT06609304 | Sep 2024 → Aug 2026 overdue | large B-cell lymphoma | Zhengzhou University | Recruiting | No outcome recorded |
| Phase 4 | NCT05108805 | Dec 2021 → Dec 2023 | diffuse large B-cell lymphoma, large B-cell lymphoma | Vanderbilt-Ingram Cancer Center | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT06935136 | Apr 2025 → Oct 2026 expected | large B-cell lymphoma | Ruijin Hospital | Not yet recruiting | No outcome recorded |
| — | NCT05800067 | Mar 2023 → Dec 2024 | — | Ruijin Hospital | Unknown | No outcome recorded |
| Phase not stated2 trials | ||||||
| — | NCT05776160 | — | follicular lymphoma, large B-cell lymphoma | Kite, A Gilead Company | Available | No outcome recorded |
| — | NCT03153462 | — | high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma | Kite, A Gilead Company | Approved for marketing | No outcome recorded |
| Comparator or background therapy12 trials | ||||||
| Phase 1 | NCT07052305 Background | Mar 2026 → Nov 2027 expected | large B-cell lymphoma | Washington University School of Medicine | Recruiting | No outcome recorded |
| Phase 1 | NCT05075603 Background | Aug 2021 → Dec 2024 | high grade B-cell lymphoma | NeoImmuneTech | Completed | No outcome recorded |
| Phase 1/2 | NCT04855253 Background | Jun 2021 → Sep 2026 | high grade B-cell lymphoma | Masonic Cancer Center, University of Minnesota | Suspended | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT07763210 Background | Sep 2026 → Mar 2028 expected | diffuse large B-cell lymphoma, mantle cell lymphoma, marginal zone lymphoma | Vanderbilt-Ingram Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07042438 Background | Feb 2026 → Jan 2029 expected | diffuse large B-cell lymphoma, high grade B-cell lymphoma with MYC and/ or BCL2 and/or BCL6 rearrangement | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06550141 Background | Sep 2024 → Aug 2027 expected | follicular lymphoma, high grade B-cell lymphoma, large B-cell lymphoma, primary mediastinal large B-cell lymphoma | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05934448 Background | Nov 2023 → Jun 2027 expected | T-cell/histiocyte rich large B cell lymphoma, primary mediastinal large B-cell lymphoma | Jennifer Crombie, MD | Recruiting | No outcome recorded |
| Phase 2 | NCT05633615 Background | Jun 2023 → Jun 2030 expected | primary mediastinal large B-cell lymphoma | SWOG Cancer Research Network | Recruiting | No outcome recorded |
| Phase 2 | NCT05757219 Background | May 2023 → Feb 2027 expected | diffuse large B-cell lymphoma | H. Lee Moffitt Cancer Center and Research Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT04205838 Background | Mar 2020 → Feb 2026 | high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma | Jonsson Comprehensive Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04071366 Background | Feb 2020 → Feb 2023 | cytokine release syndrome | Incyte Corporation | Completed | Met primary |
| Phase 3 | NCT07188558 Comparator | Jan 2026 → Dec 2029 expected | diffuse large B-cell lymphoma, large B-cell lymphoma | Lyell Immunopharma, Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 149
| Date | Issuer | Release |
|---|---|---|
| 2026-02-06 | Kite, A Gilead Company | Regulatory FDA Approves Label Update for Kite’s Yescarta® for Relapsed/Refractory Primary Central Nervous System Lymphoma kitepharma.com ↗
The updated label reinforces the robust safety data of Yescarta in eligible patients with R/R PCNSL; Yescarta is the only CAR T-cell therapy approved for R/R large B-cell lymphoma to have this Limitations of Use removed. |
| 2026-02-06 | Gilead Sciences | Regulatory FDA Approves Label Update for Kite’s Yescarta® for Relapsed/Refractory Primary Central Nervous System Lymphoma gilead.com ↗
The updated label reinforces the robust safety data of Yescarta in eligible patients with R/R PCNSL; Yescarta is the only CAR T-cell therapy approved for R/R large B-cell lymphoma to have this Limitations of Use removed. |
| 2025-12-07 | Kite, A Gilead Company | Results Yescarta® Delivers Consistent Safety, Efficacy, and Quality of Life Benefits Across Broad Range of Relapsed/Refractory Large B-cell Lymphoma Patients in New Analysis at ASH 2025 kitepharma.com ↗
This analysis reinforces that Yescarta should be considered earlier in a patient’s treatment paradigm given its curative potential as a one-time treatment and further establishes CAR T as the new standard of care for second-line treatment of large B-cell lymphoma. |
| 2025-12-07 | Gilead Sciences | Results Yescarta® Delivers Consistent Safety, Efficacy, and Quality of Life Benefits Across Broad Range of Relapsed/Refractory Large B-cell Lymphoma Patients in New Analysis at ASH 2025 gilead.com ↗
The findings were presented (Abstract #3714) during the 67th American Society of Hematology (ASH) Annual Meeting and Exposition. |
| 2025-11-03 | Kite, A Gilead Company | Results Gilead and Kite Showcase Continued Progress in Transforming Blood Cancer Care With New Cell Therapy Data at ASH 2025 kitepharma.com ↗
Efficacy, safety, and health-related quality of life patterns were observed to be consistent across both ZUMA-7 and ALYCANTE populations, supporting the use of Yescarta regardless of transplant eligibility and effectively broadening eligibility to this potentially curative, one-time treatment. |
| 2025-11-03 | Gilead Sciences | Results Gilead and Kite Showcase Continued Progress in Transforming Blood Cancer Care With New Cell Therapy Data at ASH 2025 gilead.com ↗
Efficacy, safety, and health-related quality of life patterns were observed to be consistent across both ZUMA-7 and ALYCANTE populations, supporting the use of Yescarta regardless of transplant eligibility and effectively broadening eligibility to this potentially curative, one-time treatment. |
| 2025-06-01 | Kite, A Gilead Company | Results Kite Presents New Real-World Data Supporting Use of Potentially Curative Yescarta® in Outpatient Care Setting for Patients with Relapsed/Refractory Large B-Cell Lymphoma at ASCO 2025 kitepharma.com ↗
The analysis, based on data collected from the Center for International Blood and Marrow Transplant Research (CIBMTR) registry, observed that safety and effectiveness outcomes for people treated as outpatients were comparable to those patients who received treatment in a hospital. |
| 2025-06-01 | Gilead Sciences | Results Kite Presents New Real-World Data Supporting Use of Potentially Curative Yescarta® in Outpatient Care Setting for Patients with Relapsed/Refractory Large B-Cell Lymphoma at ASCO 2025 gilead.com ↗
The analysis, based on data collected from the Center for International Blood and Marrow Transplant Research (CIBMTR) registry, observed that safety and effectiveness outcomes for people treated as outpatients were comparable to those patients who received treatment in a hospital. |
| 2024-12-09 | Kite, A Gilead Company | Results Kite’s Yescarta® Only CAR T-Cell Therapy to Show Durable Response and Long-Term Survival After Five Years in Patients With Relapsed/Refractory Non-Hodgkin Lymphomas at ASH 2024 kitepharma.com ↗
The analysis demonstrated that after a median follow-up of more than five years, patients treated with Yescarta continued to experience durable response and long-term survival. |
| 2024-12-09 | Gilead Sciences | Results Kite’s Yescarta® Only CAR T-Cell Therapy to Show Durable Response and Long-Term Survival After Five Years in Patients With Relapsed/Refractory Non-Hodgkin Lymphomas at ASH 2024 gilead.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced results from a five-year follow-up analysis of ZUMA-5, a Phase 2 study of Yescarta ® (axicabtagene ciloleucel) in patients with relapsed/refractory non-Hodgkin lymphomas (NHL) including follicular lymphoma (FL) or marginal zone lymphoma (MZL). |
| 2024-12-08 | Kite, A Gilead Company | Results Kite Presents New Data Underscoring Curative Potential of Yescarta® in Relapsed/Refractory Large B-cell Lymphoma at ASH kitepharma.com ↗
This real-world evidence (RWE) demonstrates high rates of overall survival (OS), overall response rate (ORR), complete response (CR), and other effectiveness measures, consistent with ZUMA-7 outcomes. |
| 2024-12-08 | Gilead Sciences | Results Kite Presents New Data Underscoring Curative Potential of Yescarta® in Relapsed/Refractory Large B-cell Lymphoma at ASH gilead.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced findings from three new analyses for Yescarta ® (axicabtagene ciloleucel) that demonstrate improved outcomes for people living with relapsed or refractory (R/R) large B-cell lymphoma (LBCL), which were presented at 66 th American Society of Hematology (ASH) Annual Meeting & Exposition. |
| 2024-11-05 | Kite, A Gilead Company | Results Kite to Highlight Industry-Leading CAR T-Cell Therapy Portfolio at ASH 2024, Including Positive Survival Outcomes in Both Clinical Trials and the Real-World kitepharma.com ↗
Additionally, Yescarta is the only treatment to have demonstrated superior overall survival versus standard therapy for patients with early R/R large B-cell lymphoma (LBCL) |
| 2024-11-05 | Gilead Sciences | Results Kite to Highlight Industry-Leading CAR T-Cell Therapy Portfolio at ASH 2024, Including Positive Survival Outcomes in Both Clinical Trials and the Real-World gilead.com ↗
Survival Rate for Yescarta ® Supported by Largest Real-World Analysis of CAR T for Second-Line Therapy in Patients with Relapsed/Refractory Large B-Cell Lymphoma |
| 2024-06-14 | Kite, A Gilead Company | Results New Kite Clinical Research and Real-World Evidence for Yescarta® Demonstrate Benefit From Earlier Lines of Treatment kitepharma.com ↗
Results include a comparative analysis of real-world and clinical trial data (abstract P1425), which show higher manufacturing success rate and improved T-cell performance for Yescarta in second-line versus third-line plus treatment of R/R LBCL. |
| 2024-06-14 | Gilead Sciences | Results New Kite Clinical Research and Real-World Evidence for Yescarta® Demonstrate Benefit From Earlier Lines of Treatment gilead.com ↗
Results include a comparative analysis of real-world and clinical trial data (abstract P1425), which show higher manufacturing success rate and improved T-cell performance for Yescarta in second-line versus third-line plus treatment of R/R LBCL. |
| 2024-06-03 | Kite, A Gilead Company | Results Encouraging New Data Presented on Kite’s Yescarta® for Relapsed/Refractory Central Nervous System Lymphoma kitepharma.com ↗
The findings, which also suggest a trend in efficacy, were presented today in an oral session (Abstract #2006) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. |
| 2024-06-03 | Gilead Sciences | Results Encouraging New Data Presented on Kite’s Yescarta® for Relapsed/Refractory Central Nervous System Lymphoma gilead.com ↗
The findings, which also suggest a trend in efficacy, were presented today in an oral session (Abstract #2006) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. |
| 2024-05-14 | Kite, A Gilead Company | Results Kite Data at EHA 2024 Demonstrate Positive Patient Outcomes and Advances in Delivery of CAR T-cell Therapy kitepharma.com ↗
Analysis Comparing Real-World and Clinical Trial Data Show Yescarta® Has Higher Manufacturing Success Rates and Improved T-Cell Performance, Respectively, in Second-Line vs. Third-Line+ Treatment of Large B-cell Lymphoma |
| 2024-05-14 | Gilead Sciences | Results Kite Data at EHA 2024 Demonstrate Positive Patient Outcomes and Advances in Delivery of CAR T-cell Therapy gilead.com ↗
Analysis Comparing Real-World and Clinical Trial Data Show Yescarta ® Has Higher Manufacturing Success Rates and Improved T-Cell Performance, Respectively, in Second-Line vs. Third-Line+ Treatment of Large B-cell Lymphoma |
| 2024-01-30 | Kite, A Gilead Company | Regulatory Kite Receives U.S. FDA Approval of Manufacturing Process Change Resulting in Reduced Median Turnaround Time for Yescarta® CAR T-cell Therapy kitepharma.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced that the U.S. Food and Drug Administration (FDA) has approved a manufacturing process change resulting in a shorter manufacturing time for Yescarta® (axicabtagene ciloleucel). |
| 2024-01-30 | Gilead Sciences | Regulatory Kite Receives U.S. FDA Approval of Manufacturing Process Change Resulting in Reduced Median Turnaround Time for Yescarta® CAR T-cell Therapy gilead.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced that the U.S. Food and Drug Administration (FDA) has approved a manufacturing process change resulting in a shorter manufacturing time for Yescarta ® (axicabtagene ciloleucel). |
| 2023-12-21 | Kite, A Gilead Company | Regulatory U.S. FDA Approves Label Update for Kite’s Yescarta® CAR T-Cell Therapy to Include Overall Survival Data kitepharma.com ↗ |
| 2023-12-21 | Gilead Sciences | Regulatory U.S. FDA Approves Label Update for Kite’s Yescarta® CAR T-Cell Therapy to Include Overall Survival Data gilead.com ↗ |
| 2023-12-11 | Kite, A Gilead Company | Results Long-Term Data for Kite’s Yescarta® CAR T-Cell Therapy Presented at ASH 2023 Demonstrate High Rate of Durable Response in Patients With High-Risk Large B-Cell Lymphoma kitepharma.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced results from a three-year follow-up analysis of ZUMA-12, a Phase 2 study of Yescarta® (axicabtagene ciloleucel) as first-line treatment after two cycles of chemoimmunotherapy in patients with high-risk, large b-cell lymphoma (LBCL). |
| 2023-12-11 | Kite, A Gilead Company | Results Analyses of Kite’s Yescarta®CAR T-Cell Therapy Support Curative Potential in Patients With Non-Hodgkin Lymphomas kitepharma.com ↗
This included ZUMA-1 (Abstract #4864) showing that patients with refractory large B-cell lymphoma (LBCL) who maintained a complete response (CR) at 12- and 24-months following treatment with Yescarta had a 72-month estimated disease-specific survival (DSS) of 94.4% and 100%, respectively. |
| 2023-12-11 | Gilead Sciences | Results Long-Term Data for Kite’s Yescarta® CAR T-Cell Therapy Presented at ASH 2023 Demonstrate High Rate of Durable Response in Patients With High-Risk Large B-Cell Lymphoma gilead.com ↗
At Median Follow-Up of 40.9 Months, Patients Treated with Yescarta ® Experienced an 86% Complete Response Rate and the Three-Year Estimate for Overall Survival was 81% |
| 2023-12-11 | Gilead Sciences | Results Analyses of Kite’s Yescarta®CAR T-Cell Therapy Support Curative Potential in Patients With Non-Hodgkin Lymphomas gilead.com ↗
Long-term data from the ZUMA-5 (Abstract #4868) and ZUMA-7 (Abstract #1761) studies were also presented. |
| 2023-11-02 | Kite, A Gilead Company | Results Gilead and Kite Oncology Present Data Demonstrating CAR T-cell Therapy Survival Benefit and Showcasing Latest Advances in Blood Cancer Portfolio at ASH 2023 kitepharma.com ↗
Additional Yescarta research will focus on new four-year follow-up results from ZUMA-5 evaluating Yescarta in R/R indolent non-Hodgkin lymphoma, including follicular lymphoma and marginal zone lymphoma. |
| 2023-09-18 | Kite, A Gilead Company | Results Kite’s CAR T-cell Therapy Yescarta® Demonstrates High Response Rate and Durable Remission in ALYCANTE Study as Initial Treatment for Transplant Ineligible Patients With Relapsed/Refractory Large B-cell Lymphoma kitepharma.com ↗
The study met its primary endpoint, with a complete metabolic response (CMR) of 71% (n=44, 95% confidence interval [CI], 58.1%–81.8%) at 3 months versus 12% expected with standard of care (based on historical controls). |
| 2023-09-18 | Gilead Sciences | Results Kite’s Car T-cell Therapy Yescarta® Demonstrates High Response Rate and Durable Remission in ALYCANTE Study as Initial Treatment for Transplant Ineligible Patients With Relapsed/Refractory Large B-cell Lymphoma gilead.com ↗
The study met its primary endpoint, with a complete metabolic response (CMR) of 71% (n=44, 95% confidence interval [CI], 58.1%–81.8%) at 3 months versus 12% expected with standard of care (based on historical controls). |
| 2023-06-22 | Kite, A Gilead Company | Regulatory Kite Announces Completion of Marketing Authorization Transfer for Yescarta® CAR T-cell Therapy in Japan kitepharma.com ↗
Kite Pharma, Inc., a Gilead Company (Nasdaq: GILD), today announced that the Marketing Authorization in Japan for Yescarta® (axicabtagene ciloleucel), a chimeric antigen receptor (CAR) T-cell therapy, has been transferred from Daiichi Sankyo Co., Ltd. to Gilead Sciences K.K. |
| 2023-06-22 | Gilead Sciences | Regulatory Kite Announces Completion of Marketing Authorization Transfer for Yescarta® CAR T-cell Therapy in Japan gilead.com ↗
Kite Pharma, Inc., a Gilead Company (Nasdaq: GILD), today announced that the Marketing Authorization in Japan for Yescarta ® (axicabtagene ciloleucel), a chimeric antigen receptor (CAR) T-cell therapy, has been transferred from Daiichi Sankyo Co., Ltd. to Gilead Sciences K.K. |
| 2023-06-05 | Kite, A Gilead Company | Results Kite’s Yescarta® CAR T-cell Therapy Demonstrates Significantly Longer Overall Survival Versus Standard of Care as Initial Treatment of Relapsed/Refractory Large B-cell Lymphoma kitepharma.com ↗
Yescarta is the first treatment in nearly 30 years to demonstrate a significant improvement in survival in this patient population. |
| 2023-06-05 | Gilead Sciences | Results Kite’s Yescarta® CAR T-cell Therapy Demonstrates Significantly Longer Overall Survival Versus Standard of Care as Initial Treatment of Relapsed/Refractory Large B-cell Lymphoma gilead.com ↗
Yescarta is the first treatment in nearly 30 years to demonstrate a significant improvement in survival in this patient population. |
| 2023-05-17 | Kite, A Gilead Company | Results Gilead and Kite Oncology to Showcase Advances Across the Pipeline Aiming to Address Unmet Needs in Cancer Care at ASCO 2023 kitepharma.com ↗
Late-Breaking Presentation to Detail Overall Survival Results for Yescarta® CAR T-Cell Therapy, Showing Statistical Improvement Over Standard of Care for Initial Treatment of Relapsed/Refractory Large B-Cell Lymphoma |
| 2023-05-17 | Gilead Sciences | Results Gilead and Kite Oncology to Showcase Advances Across the Pipeline Aiming to Address Unmet Needs in Cancer Care at ASCO 2023 gilead.com ↗
Late-Breaking Presentation to Detail Overall Survival Results for Yescarta ® CAR T-Cell Therapy, Showing Statistical Improvement Over Standard of Care for Initial Treatment of Relapsed/Refractory Large B-Cell Lymphoma |
| 2023-03-21 | Kite, A Gilead Company | Results Kite’s Yescarta® CAR T-cell Therapy Demonstrates a Statistically Significant Improvement in Overall Survival for Initial Treatment of Relapsed/Refractory Large B-cell Lymphoma kitepharma.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced the primary overall survival (OS) analysis results of the Phase 3 ZUMA-7 study. |
| 2023-03-21 | Gilead Sciences | Results Kite’s Yescarta® CAR T-cell Therapy Demonstrates a Statistically Significant Improvement in Overall Survival for Initial Treatment of Relapsed/Refractory Large B-cell Lymphoma gilead.com ↗ |
| 2022-12-22 | Kite, A Gilead Company | Regulatory Yescarta® Now Approved in Japan for Initial Treatment of Relapsed/Refractory Large B-Cell Lymphoma kitepharma.com ↗
Yescarta is now approved for the initial treatment of R/R LBCL patients in Japan. |
| 2022-12-22 | Gilead Sciences | Regulatory Yescarta® Now Approved in Japan for Initial Treatment of Relapsed/Refractory Large B-Cell Lymphoma gilead.com ↗
Yescarta is now approved for the initial treatment of R/R LBCL patients in Japan. |
| 2022-12-12 | Kite, A Gilead Company | Results Three-Year Follow-Up Analysis of Kite’s Yescarta® CAR T-cell Therapy (ZUMA-5 Trial) - 52% of Patients With Indolent Lymphomas Continued to Have Ongoing Responses at a Median Follow-Up of 40.5 Months kitepharma.com ↗
At the time of data cut-off, the overall response rate (ORR) was 90% (95% CI, 84‒94) and the CR rate was 75% among all patients. |
| 2022-12-12 | Gilead Sciences | Results Three-Year Follow-Up Analysis of Kite’s Yescarta® CAR T-cell Therapy (ZUMA-5 Trial) - 52% of Patients With Indolent Lymphomas Continued to Have Ongoing Responses at a Median Follow-Up of 40.5 Months gilead.com ↗
“Multi-year follow-up continues to demonstrate the durable response achieved through a single treatment with Yescarta CAR T-cell therapy for difficult-to-treat types of lymphomas,” said Frank Neumann, MD, PhD, SVP & Global Head of Clinical Development, Kite. |
| 2022-12-11 | Kite, A Gilead Company | Results Time to CAR T-cell Therapy May Impact Outcomes for Patients With Relapsed/Refractory Large B-cell Lymphoma in New CIBMTR Analysis kitepharma.com ↗
The analysis reported shorter vein-to-vein times associated with improved outcomes in patients treated with Yescarta, adjusted for key prognostic factors. |
| 2022-12-11 | Kite, A Gilead Company | Results Body of Evidence Grows From ZUMA-7 Study Supporting Initial Treatment With Kite’s Yescarta® CAR T-cell Therapy for Patients With Relapsed or Refractory Large B-cell Lymphoma kitepharma.com ↗
These results include an analysis of outcomes for patients who received subsequent treatment for their lymphoma following second-line Yescarta therapy or SOC therapy, as well as an exploratory analysis of the association between metabolic tumor volume (MTV) and clinical outcomes. |
| 2022-12-11 | Gilead Sciences | Results Time to CAR T-cell Therapy May Impact Outcomes for Patients With Relapsed/Refractory Large B-cell Lymphoma in New CIBMTR Analysis gilead.com ↗
The analysis reported shorter vein-to-vein times associated with improved outcomes in patients treated with Yescarta, adjusted for key prognostic factors. |
| 2022-12-11 | Gilead Sciences | Results Body of Evidence Grows From ZUMA-7 Study Supporting Initial Treatment With Kite’s Yescarta® CAR T-cell Therapy for Patients With Relapsed or Refractory Large B-cell Lymphoma gilead.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced findings from two new analyses of the landmark ZUMA-7 trial of Yescarta® (axicabtagene ciloleucel), the largest and longest follow-up of a CAR T-cell therapy versus standard of care (SOC) in patients with relapsed or refractory large B-cell lymphoma (r/r LBCL). |
| 2022-10-17 | Kite, A Gilead Company | Regulatory Kite’s Yescarta First CAR T-cell Therapy to Receive European Marketing Authorization for Use in Second-Line Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma kitepharma.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announces that the European Commission (EC) has granted approval for the use of Yescarta® (axicabtagene ciloleucel) for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) who relapse within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy. |
| 2022-10-17 | Gilead Sciences | Regulatory Kite’s Yescarta First CAR T-cell Therapy to Receive European Marketing Authorization for Use in Second-Line Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma gilead.com ↗
Yescarta is now the first Chimeric Antigen Receptor (CAR) T-cell therapy approved for patients in Europe who do not respond to first-line treatment. |
| 2022-09-16 | Kite, A Gilead Company | Regulatory Kite’s CAR T-cell Therapy Yescarta® First in Europe to Receive Positive CHMP Opinion for Use in Second-line Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma kitepharma.com ↗
Today’s positive CHMP opinion brings us a step closer to utilizing cell therapy earlier in the treatment journey, potentially transforming the standard of care for the most common and aggressive form of non-Hodgkin lymphoma. |
| 2022-09-16 | Gilead Sciences | Regulatory Kite’s CAR T-cell Therapy Yescarta® First in Europe to Receive Positive CHMP Opinion for Use in Second-line Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma gilead.com ↗
Today’s positive CHMP opinion brings us a step closer to utilizing cell therapy earlier in the treatment journey, potentially transforming the standard of care for the most common and aggressive form of non-Hodgkin lymphoma. |
| 2022-06-28 | Kite, A Gilead Company | Regulatory Kite’s CAR T-cell Therapy Yescarta® Granted European Marketing Authorization for the Treatment of Relapsed or Refractory Follicular Lymphoma kitepharma.com ↗ |
| 2022-06-28 | Gilead Sciences | Regulatory Kite’s CAR T-cell Therapy Yescarta® Granted European Marketing Authorization for the Treatment of Relapsed or Refractory Follicular Lymphoma gilead.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announces that the European Commission (EC) has approved its CAR T-cell therapy Yescarta ® (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy. |
| 2022-06-04 | Kite, A Gilead Company | Results Sub-analyses of Landmark ZUMA-7 Trial Reinforce Yescarta® CAR T-cell Therapy Superiority Over Standard of Care (SOC) as Initial Treatment for Patients With Relapsed or Refractory Large B-cell Lymphoma (LBCL) kitepharma.com ↗
In this analysis, response rates to axi-cel in the second-line setting were consistent regardless of level of tumor burden or LDH, which reaffirms that axi-cel should be considered the new standard of care in this earlier setting. |
| 2022-06-04 | Gilead Sciences | Results Sub-analyses of Landmark ZUMA-7 Trial Reinforce Yescarta® CAR T-cell Therapy Superiority Over Standard of Care (SOC) as Initial Treatment for Patients With Relapsed or Refractory Large B-cell Lymphoma (LBCL) gilead.com ↗
The data were presented today at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstracts #7548 and #7565). |
| 2022-06-03 | Kite, A Gilead Company | Results Yescarta® CAR T-cell Therapy Demonstrates Consistent Survival Outcomes and Safety in Real-World Setting Regardless of Race and Ethnicity kitepharma.com ↗
In the largest real-world analysis of its kind evaluating data from the CIBMTR® (Center for International Blood and Marrow Transplant Research®), overall outcomes including overall survival (OS) and progression-free survival (PFS) rates were consistent with Yescarta in the real-world setting, regardless of race and ethnicity. |
| 2022-06-03 | Gilead Sciences | Results Yescarta® CAR T-cell Therapy Demonstrates Consistent Survival Outcomes and Safety in Real-World Setting Regardless of Race and Ethnicity gilead.com ↗
The findings were presented today in an oral session during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #7571). |
| 2022-04-01 | Kite, A Gilead Company | Regulatory Yescarta® Receives U.S. FDA Approval as First CAR T-cell Therapy for Initial Treatment of Relapsed or Refractory Large B-cell Lymphoma (LBCL) kitepharma.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced the U.S. Food and Drug Administration (FDA) has approved Yescarta® (axicabtagene ciloleucel) CAR T-cell therapy for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. |
| 2022-04-01 | Gilead Sciences | Regulatory Yescarta® Receives U.S. FDA Approval as First CAR T-cell Therapy for Initial Treatment of Relapsed or Refractory Large B-cell Lymphoma (LBCL) gilead.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced the U.S. Food and Drug Administration (FDA) has approved Yescarta ® (axicabtagene ciloleucel) CAR T-cell therapy for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. |
| 2022-01-31 | Kite, A Gilead Company | Regulatory U.S. FDA Approves New Label Update for CAR T-Cell Therapy Yescarta® Showing Prophylactic Steroid Use Improves Management of Cytokine Release Syndrome kitepharma.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced the U.S. Food and Drug Administration (FDA) has approved an update to the prescribing information for Yescarta® (axicabtagene ciloleucel) to include use of prophylactic corticosteroids across all approved indications. |
| 2022-01-31 | Gilead Sciences | Regulatory U.S. FDA Approves New Label Update for CAR T-Cell Therapy Yescarta® Showing Prophylactic Steroid Use Improves Management of Cytokine Release Syndrome gilead.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced the U.S. Food and Drug Administration (FDA) has approved an update to the prescribing information for Yescarta ® (axicabtagene ciloleucel) to include use of prophylactic corticosteroids across all approved indications. |
| 2021-12-13 | Kite, A Gilead Company | Results Yescarta® ZUMA-12 Study Demonstrates 78% Complete Response Rate as Part of First-Line Treatment in Newly Diagnosed High-Risk Large B-Cell Lymphoma kitepharma.com ↗
After a single infusion of Yescarta, 89% of evaluable patients achieved a response (ORR) (n=37 evaluable for efficacy), including 78% of patients with a complete response (CR) at a median follow-up of 15.9 months. |
| 2021-12-13 | Gilead Sciences | Results Yescarta® ZUMA-12 Study Demonstrates 78% Complete Response Rate as Part of First-Line Treatment in Newly Diagnosed High-Risk Large B-Cell Lymphoma gilead.com ↗
After a single infusion of Yescarta, 89% of evaluable patients achieved a response (ORR) (n=37 evaluable for efficacy), including 78% of patients with a complete response (CR) at a median follow-up of 15.9 months. |
| 2021-12-11 | Kite, A Gilead Company | Results Yescarta® Is First CAR T-cell Therapy to Report Five-Year Survival Data From Pivotal Study Showing Durable Long-Term Survival in Patients With Refractory Large B-cell Lymphoma kitepharma.com ↗
Among all patients treated with Yescarta, the five-year overall survival (OS) rate was 42.6% (95% CI, 32.8 – 51.9). |
| 2021-12-11 | Kite, A Gilead Company | Results Yescarta® Demonstrates Durable Two-Year Clinical Benefit in Adults With Relapsed or Refractory Indolent Non-Hodgkin Lymphoma Including Follicular Lymphoma kitepharma.com ↗
The objective response rate (ORR) in FL was 94%, with a complete response (CR) rate of 79%. |
| 2021-12-11 | Kite, A Gilead Company | Results Yescarta® CAR T-Cell Therapy Quadruples Median Event-Free Survival Duration Over Standard of Care in Second-Line Relapsed or Refractory Large B-Cell Lymphoma kitepharma.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced results from the primary analysis of ZUMA-7, a global Phase 3 study evaluating Yescarta® (axicabtagene ciloleucel) as a one-time infusion, in a head-to-head study against standard of care (SOC) for adults with large B-cell lymphoma (LBCL) who relapsed or were refractory to first-line treatment. |
| 2021-12-11 | Gilead Sciences | Results Yescarta® Is First CAR T-cell Therapy to Report Five-Year Survival Data From Pivotal Study Showing Durable Long-Term Survival in Patients With Refractory Large B-cell Lymphoma gilead.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced five-year follow-up data from the pivotal ZUMA-1 trial of Yescarta ® (axicabtagene ciloleucel) in adult patients with refractory large B-cell lymphoma (LBCL). |
| 2021-12-11 | Gilead Sciences | Results Yescarta® Demonstrates Durable Two-Year Clinical Benefit in Adults With Relapsed or Refractory Indolent Non-Hodgkin Lymphoma Including Follicular Lymphoma gilead.com ↗
The objective response rate (ORR) in FL was 94%, with a complete response (CR) rate of 79%. |
| 2021-12-11 | Gilead Sciences | Results Yescarta® CAR T-Cell Therapy Quadruples Median Event-Free Survival Duration Over Standard of Care in Second-Line Relapsed or Refractory Large B-Cell Lymphoma gilead.com ↗
The findings were featured in the American Society of Hematology (ASH) press briefing today at their 63 rd ASH Annual Meeting & Exposition and in a simultaneous publication in the New England Journal of Medicine (NEJM) . |
| 2021-09-30 | Kite, A Gilead Company | Regulatory Kite Submits Supplemental Biologics License Application to U.S. Food and Drug Administration for Earlier Use of Yescarta® in Large B-cell Lymphoma kitepharma.com ↗ |
| 2021-09-30 | Gilead Sciences | Regulatory Kite Submits Supplemental Biologics License Application to U.S. Food and Drug Administration for Earlier Use of Yescarta® in Large B-cell Lymphoma gilead.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Yescarta ® (axicabtagene ciloleucel) to expand its current indication to include the treatment of adults with relapsed or refractory large B-cell lymphoma (LBCL) in the second-line setting. |
| 2021-06-28 | Kite, A Gilead Company | Results Kite Announces Yescarta® CAR T-cell Therapy Improved Event-Free Survival by 60% Over Chemotherapy Plus Stem Cell Transplant in Second-Line Relapsed or Refractory Large B-cell Lymphoma kitepharma.com ↗
With a median follow-up of two years, the study met the primary endpoint of event-free survival (EFS; hazard ratio 0.398, p <0.0001). |
| 2021-06-28 | Gilead Sciences | Results Kite Announces Yescarta® CAR T-cell Therapy Improved Event-Free Survival by 60% Over Chemotherapy Plus Stem Cell Transplant in Second-Line Relapsed or Refractory Large B-cell Lymphoma gilead.com ↗
With a median follow-up of two years, the study met the primary endpoint of event-free survival (EFS; hazard ratio 0.398, p <0.0001). |
| 2021-06-23 | Kite, A Gilead Company | Regulatory Kite Joint Venture - Fosun Kite - Gains the First CAR T-cell Therapy Approval in China kitepharma.com ↗
Kite, a Gilead Company, announced that Fosun Kite Biotechnology Co., Ltd., a joint venture between Kite and Shanghai Fosun Pharmaceutical (Group) Co., Ltd, has received approval from the China National Medical Products Administration (NMPA) for axicabtagene ciloleucel for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma. |
| 2021-06-23 | Gilead Sciences | Regulatory Kite Joint Venture - Fosun Kite - Gains the First CAR T-cell Therapy Approval in China gilead.com ↗
Kite, a Gilead Company, announced that Fosun Kite Biotechnology Co., Ltd., a joint venture between Kite and Shanghai Fosun Pharmaceutical (Group) Co., Ltd, has received approval from the China National Medical Products Administration (NMPA) for axicabtagene ciloleucel for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma. |
| 2021-06-12 | Kite, A Gilead Company | Results Longer-term Data for Kite’s Yescarta® in Relapsed or Refractory Follicular Lymphoma Demonstrate Substantial Survival Improvement Over Current Therapies in Comparative Analysis kitepharma.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced follow-up results from the pivotal ZUMA-5 trial of Yescarta® (axicabtagene ciloleucel) – the first and only CAR T-cell therapy approved in patients with relapsed or refractory indolent follicular lymphoma (FL). |
| 2021-06-12 | Gilead Sciences | Results Longer-term Data for Kite’s Yescarta® in Relapsed or Refractory Follicular Lymphoma Demonstrate Substantial Survival Improvement Over Current Therapies in Comparative Analysis gilead.com ↗
At a minimum follow-up of 18 months, 94% of patients had achieved a response, and secondary endpoints of median progression-free survival (PFS) and overall survival (OS) were not yet reached. |
| 2021-03-05 | Kite, A Gilead Company | Regulatory U.S. FDA Approves Yescarta® for Relapsed or Refractory Follicular Lymphoma After Two or More Lines of Systemic Therapy kitepharma.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Yescarta® (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. |
| 2021-03-05 | Gilead Sciences | Regulatory U.S. FDA Approves Yescarta® for Relapsed or Refractory Follicular Lymphoma After Two or More Lines of Systemic Therapy gilead.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Yescarta ® (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. |
| 2021-02-10 | Kite, A Gilead Company | Results Kite Announces New ZUMA-1 Cohort Analysis Evaluating Prophylactic Corticosteroid Use With Yescarta® in Patients With Relapsed or Refractory Large B-cell lymphoma kitepharma.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced findings from a new analysis of the ZUMA-1 trial of Yescarta® (axicabtagene ciloleucel) in adult patients with relapsed or refractory large B-cell lymphoma (LBCL). |
| 2021-02-10 | Gilead Sciences | Results Kite Announces New ZUMA-1 Cohort Analysis Evaluating Prophylactic Corticosteroid Use With Yescarta® in Patients With Relapsed or Refractory Large B-cell lymphoma gilead.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced findings from a new analysis of the ZUMA-1 trial of Yescarta ® (axicabtagene ciloleucel) in adult patients with relapsed or refractory large B-cell lymphoma (LBCL). |
| 2021-01-22 | Daiichi Sankyo | Regulatory YESCARTA® Approved in Japan for Treatment of Patients with Relapsed/Refractory Large B-Cell Lymphomas daiichisankyo.com ↗
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced the Japan Ministry of Health, Labour and Welfare (MHLW) has approved YESCARTA® (axicabtagene ciloleucel), a chimeric antigen receptor (CAR) T-cell therapy, for the treatment of adult patients with certain relapsed/refractory large B-cell lymphomas. |
| 2020-12-06 | Kite, A Gilead Company | Results Yescarta® Shows Positive Results as a First-Line Treatment for Patients With High-Risk Large B-cell Lymphoma kitepharma.com ↗
After a single infusion of Yescarta, 85 percent of patients achieved a response (n=27 evaluable for efficacy), including 74 percent of patients with a complete response. |
| 2020-12-06 | Gilead Sciences | Results Yescarta® Shows Positive Results as a First-Line Treatment for Patients With High-Risk Large B-cell Lymphoma gilead.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced results from the interim analysis of ZUMA-12, a multicenter, open-label, single-arm Phase 2 study evaluating Yescarta ® (axicabtagene ciloleucel) as first-line therapy in patients with high-risk large B-cell lymphoma (LBCL). |
| 2020-12-05 | Kite, A Gilead Company | Results Yescarta® Is First CAR T-cell Therapy to Demonstrate High Response Rates and Durable Clinical Benefit in a Pivotal Indolent Non-Hodgkin Lymphoma Study kitepharma.com ↗
After a single infusion of Yescarta, 92 percent of iNHL patients (n=104 evaluable for efficacy) responded, including 76 percent of patients achieving a complete response (CR) at a median follow-up of 17.5 months. |
| 2020-12-05 | Kite, A Gilead Company | Results New Four-Year Data Show Long-Term Survival in Patients With Large B-Cell Lymphoma Treated With Yescarta® in ZUMA-1 Trial kitepharma.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced four-year follow-up data from the pivotal ZUMA-1 trial of Yescarta® (axicabtagene ciloleucel) in adult patients with refractory large B-cell lymphoma (LBCL). |
| 2020-12-05 | Gilead Sciences | Results Yescarta® Is First CAR T-cell Therapy to Demonstrate High Response Rates and Durable Clinical Benefit in a Pivotal Indolent Non-Hodgkin Lymphoma Study gilead.com ↗
After a single infusion of Yescarta, 92 percent of iNHL patients (n=104 evaluable for efficacy) responded, including 76 percent of patients achieving a complete response (CR) at a median follow-up of 17.5 months. |
| 2020-12-05 | Gilead Sciences | Results New Four-Year Data Show Long-Term Survival in Patients With Large B-Cell Lymphoma Treated With Yescarta® in ZUMA-1 Trial gilead.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced four-year follow-up data from the pivotal ZUMA-1 trial of Yescarta ® (axicabtagene ciloleucel) in adult patients with refractory large B-cell lymphoma (LBCL). |
| 2020-11-05 | Gilead Sciences | Results Gilead and Kite to Share Latest Scientific Advances in Hematologic Malignancies at ASH 2020 gilead.com ↗
Kite Data Highlight Yescarta ® Long-Term Efficacy in Relapsed/Refractory Large B-Cell Lymphoma, its Potential as An Earlier Line of Therapy in DLBCL, as well as Results in Other Cancers |
| 2020-09-04 | Kite, A Gilead Company | Regulatory Kite Submits Supplemental Biologics License Application to U.S. Food and Drug Administration for Yescarta® in Relapsed or Refractory Indolent Non-Hodgkin Lymphomas kitepharma.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Yescarta® (axicabtagene ciloleucel) for the treatment of relapsed or refractory follicular lymphoma and marginal zone lymphoma after two or more prior lines of systemic therapy. |
| 2020-09-04 | Gilead Sciences | Regulatory Kite Submits Supplemental Biologics License Application to U.S. Food and Drug Administration for Yescarta® in Relapsed or Refractory Indolent Non-Hodgkin Lymphomas gilead.com ↗ |
| 2020-06-12 | Kite, A Gilead Company | Regulatory Kite Receives European Medicines Agency Approval for CAR T Cell Therapy Manufacturing Facility in Europe kitepharma.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced it has received approval to implement a variation to the Yescarta® (axicabtagene ciloleucel) Marketing Authorization from the European Medicine Agency (EMA) for end-to-end manufacturing. |
| 2020-06-12 | Gilead Sciences | Regulatory Kite Receives European Medicines Agency Approval for CAR T Cell Therapy Manufacturing Facility in Europe gilead.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced it has received approval to implement a variation to the Yescarta ® (axicabtagene ciloleucel) Marketing Authorization from the European Medicine Agency (EMA) for end-to-end manufacturing. |
| 2020-05-29 | Kite, A Gilead Company | Results Yescarta® (Axicabtagene Ciloleucel) Demonstrates High Rates of Response in Relapsed or Refractory Indolent Non-Hodgkin Lymphoma kitepharma.com ↗
After a single infusion of Yescarta, 93 percent of patients (n=96 evaluable for efficacy) responded, with 80 percent of patients achieving a complete response (CR) as assessed by an independent review committee. |
| 2020-05-29 | Gilead Sciences | Results Yescarta® (Axicabtagene Ciloleucel) Demonstrates High Rates of Response in Relapsed or Refractory Indolent Non-Hodgkin Lymphoma gilead.com ↗
After a single infusion of Yescarta, 93 percent of patients (n=96 evaluable for efficacy) responded, with 80 percent of patients achieving a complete response (CR) as assessed by an independent review committee. |
| 2020-03-17 | Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Regulatory Fosun Kite’s Axicabtagene Ciloleucel Granted Priority Review by China NMPA fosunpharma.com ↗
We are very pleased to see Axicabtagene Ciloleucel been granted a priority review by NMPA, further to its NDA filing acceptance as the first for any CAR-T product in China so far. |
| 2020-02-25 | Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Regulatory Fosun Kite’s New Drug Application (NDA) Filing for Axicabtagene Ciloleucel Accepted for Review by China NMPA fosunpharma.com ↗ |
| 2019-12-09 | Kite, A Gilead Company | Results Kite and the CIBMTR® Present Positive Findings From Real-World Use of Yescarta® (Axicabtagene Ciloleucel) in Relapsed or Refractory Large B-Cell Lymphoma kitepharma.com ↗
In this analysis, efficacy and safety of Yescarta were comparable to that observed in the ZUMA-1 trial, despite a larger proportion of older, more difficult-to-treat patients in the real-world setting. |
| 2019-12-09 | Gilead Sciences | Results Kite and the CIBMTR® Present Positive Findings From Real-World Use of Yescarta® (Axicabtagene Ciloleucel) in Relapsed or Refractory Large B-Cell Lymphoma gilead.com ↗
Kite, a Gilead Company (Nasdaq: GILD), and the CIBMTR ® ( Center for International Blood and Marrow Transplant Research ® ), the research collaboration between the National Marrow Donor Program ® (NMDP)/Be The Match ® and the Medical College of Wisconsin (MCW),today announced findings from an ongoing post-marketing study evaluating the safety and efficacy of Yescarta ® (axicabtagene ciloleucel) in adult patients with relapsed or refractory large B-cell lymphoma. |
| 2019-12-07 | Kite, A Gilead Company | Results Kite Announces Long-term Data From ZUMA-1 Showing Approximately Half of Refractory Large B-cell Lymphoma Patients Were Alive Three Years After Yescarta Treatment kitepharma.com ↗
47 Percent of Refractory Large B-cell Lymphoma Patients in ZUMA-1 Pivotal Phase 2 Cohorts Were Alive Three Years after a Single Infusion of Yescarta |
| 2019-12-07 | Gilead Sciences | Results Kite Announces Long-term Data From ZUMA-1 Showing Approximately Half of Refractory Large B-cell Lymphoma Patients Were Alive Three Years After Yescarta Treatment gilead.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced new data from the ZUMA-1 trial of Yescarta ® (axicabtagene ciloleucel) in adult patients with refractory large B-cell lymphoma. |
| 2019-06-03 | Kite, A Gilead Company | Results Kite Announces New Yescarta® Data From ZUMA-1 kitepharma.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced findings from two new analyses from the ZUMA-1 trial of Yescarta® (axicabtagene ciloleucel) in adult patients with relapsed or refractory large B-cell lymphoma. |
| 2019-06-03 | Gilead Sciences | Results Kite Announces New Yescarta® Data From ZUMA-1 gilead.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced findings from two new analyses from the ZUMA-1 trial of Yescarta ® (axicabtagene ciloleucel) in adult patients with relapsed or refractory large B-cell lymphoma. |
| 2018-12-03 | Kite, A Gilead Company | Results Kite Announces Updated Data From ZUMA-3 Study of KTE-X19 in Adult Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia kitepharma.com ↗
The rate of undetectable minimal residual disease (MRD) in patients who achieved complete tumor remission was 100 percent. |
| 2018-12-03 | Gilead Sciences | Results Kite Announces Updated Data From ZUMA-3 Study of KTE-X19 in Adult Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia gilead.com ↗
With a median follow-up of 15.1 months (range 3.7 – 28.6 months) following a single infusion of KTE-X19, 69 percent of evaluable patients (n=25/36) achieved complete tumor remission, defined as complete remission (CR) or CR with incomplete hematological recovery (CRi). |
| 2018-12-02 | Kite, A Gilead Company | Results Kite Announces Two-Year Data for Yescarta® (Axicabtagene Ciloleucel) in Patients With Refractory Large B-Cell Lymphoma kitepharma.com ↗
Kite, a Gilead Company (Nasdaq: GILD), announced two-year efficacy and safety data from the pivotal ZUMA-1 trial of Yescarta® (axicabtagene ciloleucel) in patients with refractory large B-cell lymphoma. |
| 2018-12-02 | Gilead Sciences | Results Kite Announces Two-Year Data for Yescarta® (Axicabtagene Ciloleucel) in Patients With Refractory Large B-Cell Lymphoma gilead.com ↗
With a minimum follow-up of two years after a single infusion of Yescarta (median follow up of 27.1 months), 39 percent of patients were in an ongoing response. |
| 2018-10-03 | Daiichi Sankyo | Regulatory Japan MHLW Grants Orphan Drug Designation to Axicabtagene Ciloleucel for Treatment of Certain Types of B-Cell Lymphoma daiichisankyo.com ↗
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that axicabtagene ciloleucel (formerly KTE-C19) has been granted Orphan Drug designation by the Japan Ministry of Health, Labour and Welfare (MHLW) for the treatment of diffuse large B-cell lymphoma (DLBCL), primary mediastinal (thymus) large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma (HGBL) and transformed follicular lymphoma (TFL), which are aggressive forms of non-Hodgkin lymphoma (NHL). |
| 2018-08-27 | Kite, A Gilead Company | Regulatory Yescarta® (Axicabtagene Ciloleucel) Receives European Marketing Authorization for the Treatment of Relapsed or Refractory DLBCL and PMBCL, After Two or More Lines of Systemic Therapy kitepharma.com ↗
The Marketing Authorization approves axicabtagene ciloleucel for use in the 28 countries of the European Union, Norway, Iceland and Liechtenstein. |
| 2018-08-27 | Gilead Sciences | Regulatory Yescarta® (Axicabtagene Ciloleucel) Receives European Marketing Authorization for the Treatment of Relapsed or Refractory DLBCL and PMBCL, After Two or More Lines of Systemic Therapy gilead.com ↗
The Marketing Authorization approves axicabtagene ciloleucel for use in the 28 countries of the European Union , Norway , Iceland and Liechtenstein . |
| 2018-06-29 | Kite, A Gilead Company | Regulatory European CHMP Adopts Positive Opinion for Yescarta® (axicabtagene ciloleucel) for the Treatment of Relapsed or Refractory DLBCL and PMBCL, After Two or More Lines of Systemic Therapy kitepharma.com ↗
The CHMP positive opinion was adopted following review by European Union (EU) regulators, including the Committee for Advanced Therapies and the CHMP. |
| 2018-06-29 | Gilead Sciences | Regulatory European CHMP Adopts Positive Opinion for Yescarta® (axicabtagene ciloleucel) for the Treatment of Relapsed or Refractory DLBCL and PMBCL, After Two or More Lines of Systemic Therapy gilead.com ↗
The CHMP positive opinion was adopted following review by European Union (EU) regulators, including the Committee for Advanced Therapies and the CHMP. |
| 2018-06-04 | Kite, A Gilead Company | Results Kite Announces New Data Analyses for CAR T Therapy in Patients with Blood Cancers at the 2018 American Society of Clinical Oncology Meeting kitepharma.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced new analyses from the ZUMA chimeric antigen receptor T (CAR T) cell therapy development program that are being presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. |
| 2018-06-04 | Gilead Sciences | Results Kite Announces New Data Analyses for CAR T Therapy in Patients with Blood Cancers at the 2018 American Society of Clinical Oncology Meeting gilead.com ↗
ZUMA-1 Data Suggest Patient Response to Yescarta ® (axicabtagene ciloleucel) at Three Months May be Predictive of Longer-Term Response in Refractory B-cell Lymphoma |
| 2017-12-11 | Kite, A Gilead Company | Results Kite Announces Data From ZUMA-3 Study of KTE-C19 in Adult Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia kitepharma.com ↗
With a minimum of eight weeks of follow-up, 71 percent of ALL patients (n=17/24) who received a single infusion of KTE-C19 achieved complete tumor remission (complete remission (CR) or CR with incomplete hematological recovery). |
| 2017-12-11 | Gilead Sciences | Results Kite Announces Data From ZUMA-3 Study of KTE-C19 in Adult Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia gilead.com ↗
With a minimum of eight weeks of follow-up, 71 percent of ALL patients (n=17/24) who received a single infusion of KTE-C19 achieved complete tumor remission (complete remission (CR) or CR with incomplete hematological recovery). |
| 2017-12-10 | Kite, A Gilead Company | Results Kite Announces Long-Term Data From Pivotal ZUMA-1 Study of Yescarta™ (Axicabtagene Ciloleucel) in Patients With Refractory Large B-cell Lymphoma kitepharma.com ↗
With a minimum follow-up of one year after a single infusion of Yescarta (median follow-up of 15.4 months), 42 percent of patients continued to respond to therapy, including 40 percent with a complete remission. |
| 2017-12-10 | Gilead Sciences | Results Kite Announces Long-Term Data From Pivotal ZUMA-1 Study of Yescarta™ (Axicabtagene Ciloleucel) in Patients With Refractory Large B-cell Lymphoma gilead.com ↗
Kite, a Gilead Company (Nasdaq: GILD), announced long-term follow-up data from the pivotal ZUMA-1 study of Yescarta™ (axicabtagene ciloleucel) in patients with refractory large B-cell lymphoma. |
| 2017-10-18 | Kite, A Gilead Company | Regulatory Kite’s Yescarta™ (Axicabtagene Ciloleucel) Becomes First CAR T Therapy Approved by the FDA for the Treatment of Adult Patients With Relapsed or Refractory Large B-Cell Lymphoma After Two or More Lines of Systemic Therapy kitepharma.com ↗ |
| 2017-10-18 | Gilead Sciences | Regulatory Kite’s Yescarta™ (Axicabtagene Ciloleucel) Becomes First CAR T Therapy Approved by the FDA for the Treatment of Adult Patients With Relapsed or Refractory Large B-Cell Lymphoma After Two or More Lines of Systemic Therapy gilead.com ↗ |
| 2017-07-31 | Gilead Sciences | Regulatory Kite Files the Industry's First CAR-T Marketing Authorization Application in Europe for Axicabtagene Ciloleucel gilead.com ↗
This application represents the first chimeric antigen receptor (CAR) T-cell therapy submitted to the EMA. |
| 2017-07-20 | Gilead Sciences | Results Kite Highlights Durable Complete Remissions Up to 56+ Months in Patients with Chemorefractory Aggressive Non-Hodgkin Lymphoma (NHL) after Anti-CD19 CAR T-Cell Therapy at the National Cancer Institute gilead.com ↗
Complete remissions (CR) were observed in 5 of the 7 evaluable patients. |
| 2017-06-05 | Gilead Sciences | Results Kite Reports 73 Percent of Patients Achieved MRD Negative Complete Remission in Updated Analysis From Phase 1 ZUMA-3 CAR-T Trial of KTE-C19 in Adult Patients With High Burden Relapsed/Refractory Acute Lymphoblastic Leukemia gilead.com ↗
Ongoing complete remissions have been observed at 2.0+ to 7.4+ months. |
| 2017-05-26 | Gilead Sciences | Regulatory Kite Receives U.S. Food and Drug Administration Priority Review for Axicabtagene Ciloleucel gilead.com ↗
Kite Pharma, Inc. , (Nasdaq:KITE), a leading cell therapy company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for axicabtagene ciloleucel. |
| 2017-04-02 | Gilead Sciences | Results Kite Presents Ongoing Response Rate in Plenary Session from its Pivotal CAR-T Trial of Axicabtagene Ciloleucel in Patients with Aggressive Non-Hodgkin Lymphoma at the 2017 American Association of Cancer Research Annual Meeting gilead.com ↗
44 Percent in Ongoing Response, Including 39 Percent in Complete Response (CR) with a Median Follow-up of 8.7 Months |
| 2017-03-31 | Gilead Sciences | Regulatory Kite Completes Submission of U.S. Biologics License Application (BLA) for Axicabtagene Ciloleucel as the First CAR-T Therapy for the Treatment of Patients With Aggressive Non-Hodgkin Lymphoma (NHL) gilead.com ↗
Kite Pharma, Inc. (Nasdaq: KITE ) today announced that it has completed the rolling submission with the U.S. Food and Drug Administration (FDA) of the Biologics License Application (BLA) for axicabtagene ciloleucel (previously known as KTE-C19) as a treatment for patients with relapsed or refractory aggressive non-Hodgkin lymphoma (NHL) who are ineligible for autologous stem cell transplant (ASCT). |
| 2017-03-30 | Gilead Sciences | Results Kite to Present Two Plenary Presentations from the ZUMA-1 Pivotal Trial of Axicabtagene Ciloleucel at the 2017 American Association of Cancer Research Annual Meeting gilead.com ↗
The results demonstrate the promise of anti-CD19 CAR T-cell therapy to transform treatment of B-cell malignancies, |
| 2017-02-28 | Gilead Sciences | Results Kite Announces Positive Topline Primary Results of Axicabtagene Ciloleucel from First Pivotal CAR-T Trial in Patients with Aggressive Non-Hodgkin Lymphoma gilead.com ↗
Kite Pharma, Inc. , (Nasdaq:KITE) today announced positive data from the primary analysis of ZUMA-1 for its lead CAR-T candidate, axicabtagene ciloleucel (previously referred to as KTE-C19), in patients with chemorefractory aggressive B-cell non-Hodgkin lymphoma (NHL). |
| 2016-12-06 | Gilead Sciences | Results Kite Pharma Presents Results of Multi-Center Pivotal ZUMA-1 Trial of Axicabtagene Ciloleucel (KTE-C19) in Aggressive Non-Hodgkin Lymphoma as Late-Breaking Abstract at Annual Meeting of American Society of Hematology gilead.com ↗
76 Percent of Patients with Diffuse Large B-Cell Lymphoma Achieved Objective Response |
| 2016-12-04 | Gilead Sciences | Regulatory Kite Pharma Initiates Rolling Submission of U.S. Biologics License Application (BLA) for KTE-C19, its Investigational anti-CD19 CAR-T Therapy, for the Treatment of Patients with Relapsed/Refractory Aggressive B-cell Non-Hodgkin Lymphoma (NHL) gilead.com ↗
Kite Pharma, Inc. (Nasdaq: KITE ) today announced that it has initiated the rolling submission with the U.S. Food and Drug Administration (FDA) of the Biologics License Application (BLA) for KTE-C19 as a treatment for patients with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) who are ineligible for autologous stem cell transplant (ASCT). |
| 2016-11-21 | Gilead Sciences | Results Kite Pharma to Present Interim Results from the ZUMA-1 Pivotal Trial of KTE-C19 in a Late-Breaking Session at the 2016 American Society of Hematology Annual Meeting gilead.com ↗
KTE-C19 Significantly Improved Objective Response Rate in Patients with Chemorefractory DLBCL at Pre-Defined Interim Analysis |
| 2016-10-07 | Gilead Sciences | Results Kite Pharma Presents 12-Month Follow-Up Data from ZUMA-1 Phase 1 at the European Society for Medical Oncology (ESMO) Annual Congress gilead.com ↗
Kite Pharma, Inc. (Nasdaq:KITE) today announced updated results from the Phase 1 portion of Kite's ZUMA-1 clinical trial of its lead product candidate, KTE-C19, in patients with chemorefractory, aggressive non-Hodgkin lymphoma (NHL). |
| 2016-09-26 | Gilead Sciences | Results Kite Pharma Announces Positive Topline KTE-C19 Data from ZUMA-1 Pivotal Trial in Patients with Aggressive Non-Hodgkin Lymphoma (NHL) gilead.com ↗
Kite Pharma, Inc. , (Nasdaq:KITE) today announced positive topline results from a pre-planned interim analysis of ZUMA-1 for its lead product candidate, KTE-C19, in patients with chemorefractory diffuse large B-cell lymphoma (DLBCL). |
| 2016-06-06 | Gilead Sciences | Results Kite Pharma Presents Ongoing Complete Responses at 9 Months in Phase 1 of ZUMA-1 in Patients with Chemorefractory Non-Hodgkin Lymphoma gilead.com ↗
Ongoing complete responses were observed in 3 patients after nine months of follow-up. |
| 2016-06-01 | Gilead Sciences | Regulatory Kite Pharma Granted Access to Priority Medicines (PRIME) Regulatory Support for KTE-C19 in the Treatment of Chemorefractory Diffuse Large B-Cell Lymphoma (DLBCL) gilead.com ↗ |
| 2016-05-02 | Gilead Sciences | Regulatory Kite Pharma Announces FDA Orphan Drug Designations for KTE-C19 in Five Additional Indications gilead.com ↗
today announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designations to Kite's lead product candidate, KTE-C19 |
| 2016-04-19 | Gilead Sciences | Results Kite Pharma Presents Updated Phase 1 Results from ZUMA-1 at the American Association of Cancer Research (AACR) Annual Meeting gilead.com ↗
Kite Pharma, Inc. (Nasdaq:KITE) ("Kite") today announced updated clinical results from the phase 1 portion of Kite's ZUMA-1 trial of its lead product candidate, KTE-C19, in patients with chemorefractory, aggressive non-Hodgkin lymphoma (NHL). |
| 2015-12-07 | Gilead Sciences | Regulatory Kite Pharma Receives FDA Breakthrough Therapy Designation for KTE-C19 for the Treatment of Refractory, Aggressive Non Hodgkin Lymphoma (NHL) gilead.com ↗
We are pleased to receive this designation and look forward to working more closely with the FDA as we continue to advance our program for KTE-C19. |
| 2015-12-07 | Gilead Sciences | Results Kite Pharma Presents Phase 1 Results From ZUMA-1 at the 57th American Society of Hematology (ASH) Annual Meeting gilead.com ↗
Kite Pharma, Inc. (Nasdaq:KITE) today announced clinical results and biomarker data for the phase 1 portion of Kite's ZUMA-1 trial of KTE-C19 in patients with refractory, aggressive non-Hodgkin lymphoma (NHL). |
| 2015-12-07 | Gilead Sciences | Results Kite Pharma Announces Clinical Biomarker Results of Anti-CD19 CAR T Cell Therapy at the 57th American Society of Hematology Annual Meeting (ASH) gilead.com ↗
The objective response rate was 71% (35% complete remission (CR)) overall and 70% (40% CR) among those treated with cells manufactured using the new process. |
| 2015-10-15 | Gilead Sciences | Regulatory Kite Pharma Receives Positive Opinions for Orphan Drug Designation in the European Union (EU) for KTE-C19 in Three Additional Hematological Indications gilead.com ↗
Kite Pharma, Inc. (Nasdaq:KITE), a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT™) products for the treatment of cancer, today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has adopted positive opinions recommending KTE-C19 for designation as an orphan medicinal product for the treatment of ALL, CLL/SLL, and FL. |
| 2015-09-11 | Gilead Sciences | Regulatory Kite Pharma Receives Positive Opinion for Orphan Drug Designation in the European Union for KTE-C19, Kite's Lead Cancer T-Cell Immunotherapy gilead.com ↗
Kite Pharma, Inc. (Kite) (Nasdaq:KITE) announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion recommending KTE-C19 for designation as an orphan medicinal product for the treatment of PMBCL and MCL. |
| 2015-08-17 | Gilead Sciences | Results Kite Pharma Provides Update on KTE-C19 Clinical Trial gilead.com ↗
Complete responses have been observed by investigators. |
| 2015-06-02 | Gilead Sciences | Results Kite Pharma Presents Clinical Biomarker Results in Patients Treated With Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy at the 2015 ASCO Annual Meeting gilead.com ↗
In this updated biomarker analysis, conditioning chemotherapy was associated with a significant rise in homeostatic cytokines and chemokines, which could favor expansion, activation, and trafficking of CAR T cells. |
| 2015-01-06 | Gilead Sciences | Regulatory Kite Pharma Granted Orphan Drug Designation in the European Union for KTE-C19, Kite's Lead Anti-CD19 Chimeric Antigen Receptor (CAR) T Cell Therapy gilead.com ↗
We are pleased with the approval of orphan drug designation for KTE-C19 in the EU, another important milestone for Kite Pharma and for the progress of our lead program, |
| 2014-12-22 | Gilead Sciences | Regulatory Kite Pharma Submits Investigational New Drug Application for Phase 1/2 Trial of KTE-C19, Anti-CD19 Chimeric Antigen Receptor (CAR) T Cell Therapy, for the Treatment of Refractory Aggressive Non-Hodgkin Lymphoma gilead.com ↗
today announced the Company has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to conduct a Phase 1/2 study of KTE-C19, the Company's investigational anti-CD19 CAR T cell therapy, for the treatment of patients with refractory aggressive non-Hodgkin lymphoma (NHL). |
| 2014-11-18 | Gilead Sciences | Results Kite Pharma Announces Presentations at the Upcoming 56th American Society of Hematology Annual Meeting gilead.com ↗
Intent-to-Treat Results of a Phase I Trial of CD19 Chimeric Antigen Receptor Engineered T Cells Using a Consistent Treatment Regimen Reveals a 67% Complete Response Rate in Relapsed, Refractory Acute Lymphoblastic Leukemia |
| 2014-11-17 | Gilead Sciences | Regulatory Kite Pharma Receives Positive Opinion for Orphan Drug Designation in the European Union for KTE-C19, Kite's Lead Investigational Cancer Immunotherapy gilead.com ↗ |
| 2014-08-25 | Gilead Sciences | Results Kite Pharma Announces Patients With Aggressive Non-Hodgkin's Lymphoma Experience Positive Results After Receiving Anti-CD19 Chimeric Antigen Receptor (CAR) T Cells at the National Cancer Institute (NCI) gilead.com ↗
Of the seven evaluable chemotherapy-refractory DLBCL patients, six showed a response (four complete remissions and two partial remissions), and one had stable disease. |
All press releases naming this drug 180 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 180 releases opens the full record — a long page | ||
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 52 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Axicabtagene Ciloleucel | “Axicabtagene ciloleucel (Axi-cel) is an autologous anti-CD-19 chimeric antigen receptor(CAR) T-cell therapy approved by FDA in 2017 for the treatment of patients with...” NCT05800067 ↗42“A Single-arm, Multicenter Clinical Study Evaluating the Efficacy and Safety of Axicabtagene Ciloleucel Injection Manufactured by an Automated Process” NCT07606937 ↗ “Standard of care: Will be given on day 0 and will be either axicabtagene ciloleucel or lisocabtagene maraleucel .” NCT07052305 ↗ “The CAR T-cell therapies to be used in this study are axicabtagene-ciloleucel and lisocabtagene maraleucel.” NCT05934448 ↗ |
| Known as | axi-cel | “ZUMA-12 is a multicenter phase 2 study evaluating axicabtagene ciloleucel (axi-cel) autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy as part of first-line...” PMID 39938019 ↗ May 20256“Axicabtagene ciloleucel (Axi-cel) is an autologous anti-CD-19 chimeric antigen receptor(CAR) T-cell therapy approved by FDA in 2017 for the treatment of patients with...” NCT05800067 ↗ “ZUMA-24 is a Phase 2, open-label, multicenter study that investigated safety and efficacy of axicabtagene ciloleucel (axi-cel), an autologous anti-CD19 chimeric antigen...” PMID 40948517 ↗ Aug 2025 “A Phase I Study of Anti-CD19 CAR T-cell Therapy With Axicabtagene Ciloleucel (Axi-cel) in Patients With Relapsed/Refractory Primary and Secondary Central Nervous System (CNS) Lymphoma” NCT04608487 ↗ “Axicabtagene ciloleucel (axi-cel), an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy” PMID 29226797 ↗ Dec 2017 “Lymphodepleting Chemotherapy: Axicabtagene Ciloleucel (axi-cel)” NCT07479797 ↗ “axi-cel” NCT03391466 ↗ |
| Known as | Axicabtagen ciloleucel | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989989 ↗ |
| Known as | KTE-C19 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02926833 ↗ |
| Known as | YESCARTA | “Yescarta is an autologous anti-CD19 CAR T cell therapy manufactured from the patient's own T cells, which have been extracted and then reprogrammed with CAR molecules to help...” NCT05757219 ↗3“YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting” NCT05108805 ↗ |
| Action | Deplete | “The CAR on the T cells may bind to and kill cells that express CD19” NCT04608487 ↗ |
| Modality | Cell therapy | “an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy” PMID 39240498 ↗ Sep 2024 |
| Route | Intravenous | “administered intravenously” NCT02348216 ↗ |
| Target | CD19 | “anti-CD19 chimeric antigen receptor (CAR) T cells/kg” NCT02926833 ↗ |