Drugs / idecabtagene vicleucel
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed plasma cell myeloma 5 milestones | |||||
| Filed | US (FDA) | — | plasma cell myeloma | 2020-11-05 | “the U.S. FDA has accepted for Priority Review the Biologics License Application (BLA) for idecabtagene vicleucel (ide-cel; bb2121)” bms.com ↗ |
| Filed | EU (EMA) | Abecma | plasma cell myeloma | 2020-05-20 | “Bristol Myers Squibb's Marketing Authorization Application for Abecma is currently under review by the European Medicines Agency.” bms.com ↗ “EMA has validated its Marketing Authorization Applications (MAA) for both idecabtagene vicleucel (ide-cel, bb2121) and CC-486.” bms.com ↗ |
| Filed | US (FDA) | — | plasma cell myeloma | 2020-03-31 | “today announced the submission of their Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for idecabtagene vicleucel (ide-cel; bb2121)” bms.com ↗ |
| Filed | Other | Abecma | plasma cell myeloma | — | “Regulatory applications for Abecma are also currently under review in Canada, Switzerland and Japan.” bms.com ↗ |
| Filed | Japan (PMDA) | Abecma | plasma cell myeloma | — | “Regulatory applications for Abecma are also currently under review in Canada, Switzerland and Japan.” bms.com ↗ |
| Filed relapsed/refractory diffuse large B-cell lymphoma 2 milestones | |||||
| Filed | US (FDA) | — | relapsed/refractory diffuse large B-cell lymphoma | 2020-07-29 | “today announced the submission of their Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for idecabtagene vicleucel (ide-cel; bb2121)” bms.com ↗ |
| Rejected (CRL) | US (FDA) | — | relapsed/refractory diffuse large B-cell lymphoma | 2020-05-13 | “received a Refusal to File letter from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for idecabtagene vicleucel (ide-cel; bb2121)” bms.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Abecma | — | 2021-08-18 | europa.eu ↗ |
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials · 1 met primary | ||||||
| Phase 1 | NCT07544589 | Apr 2026 → Apr 2046 expected | biliary tract cancer, colorectal cancer, esophageal adenocarcinoma, gastric adenocarcinoma +1 | Dispatch Biotherapeutics | Recruiting | No outcome recorded |
| Phase 1 | NCT04855136 | Jun 2021 → Apr 2025 | plasma cell myeloma | Celgene Corporation | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT04196491 | May 2020 → Jun 2023 | plasma cell myeloma | Celgene Corporation | Completed | No outcome recorded |
| Phase 1 | NCT02658929 | Dec 2015 → Jul 2019 | plasma cell myeloma | Celgene Corporation | Completed | Met primary |
| Phase 25 trials · 2 met primary | ||||||
| Phase 2 | NCT05393804 | May 2022 → May 2027 expected | plasma cell myeloma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05032820 | Jan 2022 → Aug 2024 | plasma cell myeloma | Medical College of Wisconsin | Completed | Met primary |
| 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 | NCT03601078 | Dec 2018 → Jan 2026 | plasma cell myeloma | Celgene Corporation | Completed | No outcome recorded |
| Phase 2 | NCT03361748 | Dec 2017 → Dec 2023 | plasma cell myeloma | Celgene Corporation | Completed | Met primary |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT06045806 | Oct 2023 → Aug 2025 overdue | plasma cell myeloma | Celgene Corporation | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03651128 | Apr 2019 → Apr 2026 | plasma cell myeloma | Celgene Corporation | Completed | Met primary |
| Phase not stated1 trial | ||||||
| — | NCT04771078 | — | plasma cell myeloma | Celgene Corporation | Available | No outcome recorded |
News releases announcing trial results or a regulatory action · 31
| Date | Issuer | Release |
|---|---|---|
| 2026-08-06 | Dispatch Biotherapeutics | Regulatory Dispatch Bio Announces First Patient Dosed in Phase 1 Study of DISP-10, a Novel Investigational Immunotherapy, in Advanced Gastrointestinal (GI) Cancers dispatchbio.com ↗
Additionally, DISP-10 has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of advanced GI cancers. |
| 2025-06-26 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Approves Streamlined Patient Monitoring Requirements and Removal of REMS Programs within Bristol Myers Squibb’s Cell Therapy Labels bms.com ↗
Across both labels, the FDA has approved the reduction or removal of specific patient monitoring requirements for Breyanzi and Abecma. |
| 2024-04-05 | Bristol-Myers Squibb | Regulatory U.S. FDA Approves Bristol Myers Squibb and 2seventy bio’s Abecma for Triple-Class Exposed Relapsed or Refractory Multiple Myeloma After Two Prior Lines of Therapy bms.com ↗
This approval expands Abecma’s indication, making it available in earlier lines to patients who have relapsed or become refractory after exposure to these three main classes of treatment (triple-class exposed), after two prior lines of therapy. |
| 2024-03-20 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb’s Abecma (idecabtagene vicleucel) Becomes First CAR T Cell Therapy Approved in the European Union in Earlier Lines for Triple-Class Exposed Relapsed and Refractory Multiple Myeloma bms.com ↗
Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has granted approval to Abecma ® (idecabtagene vicleucel; ide-cel) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. |
| 2024-03-15 | Bristol-Myers Squibb | Regulatory FDA Advisory Committee Votes in Favor of Bristol Myers Squibb’s and 2seventy bio’s Abecma for Triple-Class Exposed Multiple Myeloma in Earlier Lines of Therapy bms.com ↗
The recommendation from the ODAC will be considered by the FDA during its ongoing review of the supplemental Biologics License Application (sBLA) for Abecma for this patient population. |
| 2024-02-05 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb and 2seventy bio Share Update on U.S. FDA Oncologic Drugs Advisory Committee Meeting for Abecma in Triple-Class Exposed Multiple Myeloma Based on KarMMa-3 Study bms.com ↗
The companies anticipate that the ODAC will review data related to the secondary endpoint of overall survival (OS) from the study. |
| 2024-01-26 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb Receives Positive CHMP Opinion for CAR T Cell Therapy Abecma (idecabtagene vicleucel)in Earlier Lines of Therapy for Triple-Class Exposed Relapsed and Refractory Multiple Myeloma bms.com ↗
This is the first positive CHMP opinion in earlier lines of therapy for a chimeric antigen receptor (CAR) T cell therapy in the treatment of relapsed and refractory multiple myeloma |
| 2023-12-11 | Bristol-Myers Squibb | Results Abecma Delivers Sustained Progression-Free Survival Versus Standard Regimens in Earlier Lines of Therapy for Relapsed and Refractory Multiple Myeloma Based on Longer-Term Follow-up from KarMMa-3 bms.com ↗
At median follow-up of more than 30 months, Abecma maintained a 51% reduction in risk of disease progression or death with median PFS of 13.8 months compared with 4.4 months for standard regimens |
| 2023-12-06 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb's Abecma® Becomes First CAR T Approved for Use in Earlier Lines of Therapy for Patients with Relapsed or Refractory Multiple Myeloma in Japan bms.com ↗ |
| 2023-11-20 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb and 2seventy bio Provide Update on U.S. FDA Review of sBLA for Abecma (idecabtagene vicleucel) in Earlier Lines of Therapy for Triple-Class Exposed Relapsed or Refractory Multiple Myeloma bms.com ↗
The FDA also informed the companies that a decision on the application will not be made by the Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2023. |
| 2023-11-02 | Bristol-Myers Squibb | Results Bristol Myers Squibb’s First Disclosures and New Data at ASH 2023 Highlight Company’s Leadership and Progress in Cell Therapy, Targeted Protein Degradation and Novel Approaches in Hematology bms.com ↗
Multiple new analyses of the Phase 3 KarMMa-3 study of Abecma ® (idecabtagene vicleucel) in triple-class exposed relapsed and refractory multiple myeloma in earlier lines of therapy, including longer-term progression-free survival data and clinically meaningful improvements in patient-reported outcomes |
| 2023-04-17 | Bristol-Myers Squibb | Regulatory Regulatory Applications Accepted Across Three Regions Globally for Abecma for Earlier Use in Adults with Triple-Class Exposed Relapsed and/or Refractory Multiple Myeloma bms.com ↗
U.S. FDA accepted Bristol Myers Squibb and 2seventy bio’s supplemental Biologics License Application and has assigned a target action date of December 16, 2023 |
| 2023-02-10 | Bristol-Myers Squibb | Results Abecma (idecabtagene vicleucel) Reduced the Risk of Disease Progression or Death by 51% Versus Standard Regimens in Earlier Lines of Therapy for Relapsed and Refractory Multiple Myeloma Based on Results from Phase 3 KarMMa-3 Study bms.com ↗
Abecma more than tripled progression-free survival (13.3 months vs. 4.4 months) compared with standard regimens for triple-class exposed multiple myeloma |
| 2023-02-02 | Bristol-Myers Squibb | Results Bristol Myers Squibb Reports Fourth Quarter and Full-Year Financial Results for 2022 bms.com ↗ |
| 2022-12-12 | Bristol-Myers Squibb | Results Bristol Myers Squibb Announces First Disclosures and New Data at ASH 2022, Demonstrating Commitment to Raising Standards in Treatment Through Broad Multiple Myeloma Portfolio bms.com ↗ |
| 2022-08-10 | Bristol-Myers Squibb | Results Bristol Myers Squibb and 2seventy bio Announce Topline Results from KarMMa-3 Trial Showing Abecma (idecabtagene vicleucel) Significantly Improves Progression-Free Survival Versus Standard Regimens in Relapsed and Refractory Multiple Myeloma bms.com ↗
Results of a pre-specified interim analysis conducted through an independent review committee showed that KarMMa-3 met its primary endpoint of demonstrating a statistically significant improvement in progression-free survival. |
| 2022-05-19 | Bristol-Myers Squibb | Results Bristol Myers Squibb Data at ASCO and EHA 2022 Highlight Progress in Transforming Treatment for Patients with Cancer and Blood Disorders bms.com ↗
Correlative analysis of characteristics of patients treated with Abecma (ide-cel) in the KarMMa and KarMMa-2 clinical trials , with CAR T product quality attributes, informs further insights into potentially optimizing patient selection for CAR T manufacturing and improving clinical outcomes. |
| 2022-01-20 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb Receives Approval for Abecma (idecabtagene vicleucel), the First CAR T Therapy Approved for the Treatment of Multiple Myeloma in Japan bms.com ↗
Abecma is the first CAR T cell therapy approved for the treatment of R/R multiple myeloma in Japan. |
| 2021-08-19 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb Receives European Commission Approval for Abecma (Idecabtagene Vicleucel), the First Anti-BCMA CAR T Cell Therapy for Relapsed and Refractory Multiple Myeloma bms.com ↗ |
| 2021-06-25 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb Receives Positive CHMP Opinion for Anti-BCMA CAR T Cell Therapy Abecma (idecabtagene vicleucel) for Relapsed and Refractory Multiple Myeloma bms.com ↗
Bristol Myers Squibb (NYSE: BMY) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting Conditional Marketing Authorization for Abecma (idecabtagene vicleucel; ide-cel), the company’s B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy . |
| 2021-05-19 | Bristol-Myers Squibb | Results Long-Term Data from Pivotal KarMMa Study Continue to Demonstrate Deep and Durable Responses and Predictable Safety Profile with Bristol Myers Squibb and bluebird bio’s Abecma (idecabtagene vicleucel) in Relapsed or Refractory Multiple Myeloma bms.com ↗
These data include updated results (Abstract #8016) and analysis of characteristics of treatment-associated neurotoxicity (Abstract #8036) from the KarMMa study of Abecma in triple-class exposed relapsed or refractory multiple myeloma. |
| 2021-05-12 | Bristol-Myers Squibb | Results Bristol Myers Squibb Presents New Research at ASCO and EHA 2021 Featuring Novel Approaches and Demonstrating Significant Progress to Improve Survival in Cancer and Blood Disorders bms.com ↗
New long-term results from KarMMa study of Abecma (idecabtagene vicleucel) and combination data from an early phase study of novel CELMoD agent iberdomide underscore potential of new therapeutic approaches for patients with multiple myeloma |
| 2021-03-26 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Approves Bristol Myers Squibb’s and bluebird bio’s Abecma (idecabtagene vicleucel), the First Anti-BCMA CAR T Cell Therapy for Relapsed or Refractory Multiple Myeloma bms.com ↗ |
| 2020-12-05 | Bristol-Myers Squibb | Results Bristol Myers Squibb and bluebird bio Present Data Highlighting Anti-BCMA CAR T Cell Therapy, Ide-cel, in Relapsed and Refractory Multiple Myeloma at ASH 2020 bms.com ↗
Longer-term data from Phase 1 CRB-401 study evaluating ide-cel in relapsed and refractory multiple myeloma show ongoing deep and durable responses and median overall survival of 34.2 months 1 |
| 2020-09-22 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol Myers Squibb and bluebird bio Application for Anti-BCMA CAR T Cell Therapy Idecabtagene Vicleucel (Ide-cel, bb2121) bms.com ↗
Ide-cel is the first CAR T cell therapy accepted for regulatory review for multiple myeloma |
| 2020-07-29 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb and bluebird bio Announce Submission of Biologics License Application (BLA) to FDA for Idecabtagene Vicleucel (Ide-cel, bb2121) for Adults with Relapsed and Refractory Multiple Myeloma bms.com ↗
This submission provides further details on the Chemistry, Manufacturing and Controls (CMC) module to address the outstanding regulatory requests from the FDA in May 2020 following the original BLA submission from March 2020. |
| 2020-05-22 | Bristol-Myers Squibb | Regulatory European Medicines Agency Validates Bristol Myers Squibb’s Applications for Idecabtagene Vicleucel (Ide-cel, bb2121) and CC-486 bms.com ↗
Bristol Myers Squibb (NYSE: BMY) today announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Applications (MAA) for both idecabtagene vicleucel (ide-cel, bb2121) and CC-486. |
| 2020-05-13 | Bristol-Myers Squibb | Results Bristol Myers Squibb and bluebird bio to Present Updated Positive Results from Pivotal KarMMa Study of Ide-cel in Relapsed and Refractory Multiple Myeloma Patients at ASCO20 bms.com ↗
Ide-cel, an investigational CAR T cell therapy for multiple myeloma, met primary endpoint and key secondary endpoints |
| 2020-05-13 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb and bluebird bio Provide Regulatory Update on Idecabtagene Vicleucel (ide-cel, bb2121) for the Treatment of Patients with Multiple Myeloma bms.com ↗
Upon preliminary review, the FDA determined that the Chemistry, Manufacturing and Control (CMC) module of the BLA requires further detail to complete the review. |
| 2020-03-31 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb and bluebird bio Announce Submission of Biologics License Application (BLA) for Anti-BCMA CAR T Cell Therapy Idecabtagene Vicleucel (Ide-cel, bb2121) to FDA bms.com ↗
Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc . (Nasdaq: BLUE) today announced the submission of their Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for idecabtagene vicleucel (ide-cel; bb2121), the companies’ lead investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, for the treatment of adult patients with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. |
| 2019-12-06 | Bristol-Myers Squibb | Results Bristol-Myers Squibb and bluebird bio Announce Positive Top-line Results from the Pivotal Phase 2 KarMMa Study of Ide-cel in Relapsed and Refractory Multiple Myeloma bms.com ↗
Bristol-Myers Squibb Company (NYSE: BMY) and bluebird bio, Inc . (Nasdaq: BLUE) today announced positive top-line results from KarMMa, a pivotal, open-label, single arm, multicenter, Phase 2 study of idecabtagene vicleucel (ide-cel; bb2121). |
All press releases naming this drug 32 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 15 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | idecabtagene vicleucel | “Idecabtagene vicleucel (ide-cel; bb2121) is a B-cell maturation antigen-directed chimeric antigen receptor (CAR) T cell therapy approved for treatment of patients with heavily...” PMID 36794354 ↗ Feb 20234“Idecabtagene vicleucel (ide-cel), a B-cell maturation antigen-directed chimeric antigen receptor (CAR) T-cell therapy” PMID 36762851 ↗ Feb 2023 “DISP-10, a combination therapy consisting of DV-10 (adenovirus) and idecabtagene vicleucel (ide-cel” NCT07544589 ↗ |
| Known as | Abecma | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03642626 ↗ |
| Known as | Anti-bcma car t cell | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298199 ↗ |
| Known as | bb2121 | “A Study of Whether Ide-cel (bb2121) Can Be Made From People With Multiple Myeloma Who Have Had a Hematopoietic Cell Transplant” NCT05393804 ↗ |
| Known as | ide-cel | “Idecabtagene vicleucel (ide-cel; bb2121) is a B-cell maturation antigen-directed chimeric antigen receptor (CAR) T cell therapy approved for treatment of patients with heavily...” PMID 36794354 ↗ Feb 20235“Idecabtagene vicleucel (ide-cel) is a chimeric antigen receptor (CAR) T-cell therapy approved for relapsed and refractory multiple myeloma (RRMM).” PMID 41894689 ↗ Jun 2026 “A Study of Whether Ide-cel (bb2121) Can Be Made From People With Multiple Myeloma Who Have Had a Hematopoietic Cell Transplant” NCT05393804 ↗ “Idecabtagene vicleucel (ide-cel), a B-cell maturation antigen-directed chimeric antigen receptor (CAR) T-cell therapy” PMID 36762851 ↗ Feb 2023 “idecabtagene vicleucel (ide-cel, BCMA-directed chimeric antigen receptor” NCT07544589 ↗ |
| Known as | Idecabtagen vicleucel | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298199 ↗ |
| Modality | Cell therapy | “bb2121 chimeric antigen receptor (CAR) modified T cells” NCT03361748 ↗ |
| Route | Other | “bb2121 autologous CAR T cells will be infused” NCT02658929 ↗ |
| Target | TNFRSF17 | “Tumor necrosis factor receptor superfamily member 17 binding agent” CHEMBL4298199 ↗ |