Drugs / Tafasitamab
Tafasitamab
also known as
MOR00208 · Xmab5574 · Minjuvi · Monjuvi · Monjuvi (tafasitamab-cxix) for injection · MOR208 · Tafa · Tafasitamab cxix
Monoclonal antibody targets CD19
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed diffuse large B-cell lymphoma 5 milestones | |||||
| Filed | China (NMPA) | — | diffuse large B-cell lymphoma | 2025-03-27 | “坦昔妥单抗联合来那度胺治疗复发/难治性弥漫大B细胞淋巴瘤（r/r DLBCL）上市申请（BLA）在中国大陆已获受理并纳入优先审评。” innocarepharma.com ↗ |
| Filed | China (NMPA) | — | diffuse large B-cell lymphoma | 2024-06-20 | “中国国家药品监督管理局（NMPA）已受理CD19单抗坦昔妥单抗（tafasitamab）联合来那度胺治疗不适合自体干细胞移植条件的复发/难治弥漫性大B细胞淋巴瘤（DLBCL）成人患者的生物制品上市许可申请（BLA）” innocarepharma.com ↗ |
| Filed | Other | — | diffuse large B-cell lymphoma | 2022-08-30 | “has submitted a marketing authorization application for tafasitamab in combination with lenalidomide to ANVISA” knighttx.com ↗ “tafasitamab联合来那度胺治疗不适合自体干细胞移植条件的复发/难治弥漫性大B细胞淋巴瘤（DLBCL）成人患者的生物制品许可申请（BLA）已获香港卫生署受理。” innocarepharma.com ↗ “Tafasitamab新药上市申请已在香港提交” innocarepharma.com ↗ |
| Filed | EU (EMA) | — | diffuse large B-cell lymphoma | 2020-05-20 | “A marketing authorization application (MAA) seeking the approval of tafasitamab in combination with lenalidomide in the EU has been validated” incyte.com ↗ “In May, Incyte and MorphoSys announced the validation of the European Marketing Authorization Application (MAA) for tafasitamab.” incyte.com ↗ “today announced the validation of the European Marketing Authorization Application (MAA) for tafasitamab, an anti-CD19 antibody.” incyte.com ↗ “MAA seeking the approval of tafasitamab in combination with lenalidomide in the European Union has been validated” incyte.com ↗ “MAA seeking the approval of tafasitamab in combination with lenalidomide in the EU has been validated” incyte.com ↗ |
| Filed | US (FDA) | — | diffuse large B-cell lymphoma | — | “The U.S. Food and Drug Administration (FDA) recently accepted filing of MorphoSys' Biologics License Application (BLA) for tafasitamab” incyte.com ↗ “In December 2019, MorphoSys submitted a Biologics License Application (BLA) to the FDA for tafasitamab” xencor.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved · conditional | EU (EMA) | Minjuvi | — | 2021-08-26 | europa.eu ↗ |
Trials 51
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04161248 | Sep 2020 → Dec 2026 expected | B-cell non-Hodgkin lymphoma | Canadian Cancer Trials Group | Active not recruiting | No outcome recorded |
| Phase 14 trials · 1 met primary | ||||||
| Phase 1 | NCT05993611 | Feb 2024 → May 2028 | chronic graft versus host disease, hematologic disorder | City of Hope Medical Center | Suspended | No outcome recorded Stop: Business |
| Phase 1 | NCT05943496 | Oct 2023 → Jan 2027 expected | B-cell chronic lymphocytic leukemia | OHSU Knight Cancer Institute | Recruiting | No outcome recorded |
| Phase 1 | NCT04134936 | Dec 2019 → Feb 2021 | diffuse large B-cell lymphoma | MorphoSys AG | Completed | No outcome recorded |
| Phase 1 | NCT01161511 | Sep 2010 → Jan 2013 | chronic lymphocytic leukemia/small lymphocytic lymphoma | Xencor, Inc. | Completed | Met primary |
| Phase 1/211 trials | ||||||
| Phase 1/2 | NCT06434363 | Jul 2024 → Dec 2028 expected | lupus nephritis, systemic lupus erythematosus, systemic sclerosis | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06029309 | May 2024 → May 2028 expected | mantle cell lymphoma | Alvaro Alencar, MD | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05626322 | Aug 2023 → Aug 2024 | diffuse large B-cell lymphoma | Pfizer | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT05366218 | Mar 2023 → Jul 2028 expected | B-cell acute lymphoblastic leukemia, B-cell childhood acute lymphoblastic leukemia | University Hospital Tuebingen | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05455697 | Jan 2023 → Oct 2026 expected | high grade B-cell lymphoma | University of Washington | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05222555 | Jul 2022 → Jul 2024 overdue | diffuse large B-cell lymphoma | Incyte Corporation | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05351593 | Jun 2022 → Dec 2026 expected | central nervous system non-hodgkin lymphoma | James Rubenstein | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04809467 | Sep 2021 → Oct 2024 | B-cell chronic lymphocytic leukemia | Incyte Corporation | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT04661007 | Dec 2020 → Jul 2025 overdue | diffuse large B-cell lymphoma | Incyte Biosciences Japan GK | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04607772 | Nov 2020 → Dec 2025 | diffuse large B-cell lymphoma | Karyopharm Therapeutics Inc | Withdrawn | No outcome recorded Stop: Business |
| Phase 1/2 | NCT03930953 | May 2019 → Apr 2027 expected | non-Hodgkin lymphoma | Celgene Corporation | Active not recruiting | No outcome recorded |
| Phase 229 trials | ||||||
| Phase 2 | NCT07582159 | Dec 2026 → Apr 2029 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | City of Hope Medical Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07502872 | Nov 2026 → Jan 2030 expected | high grade B-cell lymphoma | Brown University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07731789 | Oct 2026 → Oct 2030 expected | follicular lymphoma | University of Washington | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07585747 | Apr 2026 → Dec 2029 expected | follicular lymphoma | Institute of Hematology & Blood Diseases Hospital, China | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07621406 | Jan 2026 → Dec 2028 expected | diffuse large B-cell lymphoma | The First Affiliated Hospital of Soochow University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT07104565 | Dec 2025 → Sep 2027 expected | thrombocytopenia due to immune destruction | Incyte Corporation | Recruiting | No outcome recorded |
| Phase 2 | NCT07030699 | Aug 2025 → Mar 2026 | lymphoma | Memorial Sloan Kettering Cancer Center | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT06792825 | Aug 2025 → Jul 2029 expected | follicular lymphoma, marginal zone lymphoma | Masonic Cancer Center, University of Minnesota | Recruiting | No outcome recorded |
| Phase 2 | NCT07126236 | Aug 2025 → Dec 2031 expected | large B-cell lymphoma | Spanish Lymphoma Cooperative Group | Recruiting | No outcome recorded |
| Phase 2 | NCT06760156 | Mar 2025 → Jan 2027 expected | large B-cell lymphoma | H. Lee Moffitt Cancer Center and Research Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT05583071 | Aug 2024 → Feb 2027 expected | non-Hodgkin lymphoma | University of Cologne | Recruiting | No outcome recorded |
| Phase 2 | NCT05910801 | Jan 2024 → Dec 2029 expected | mantle cell lymphoma | Academic and Community Cancer Research United | Recruiting | No outcome recorded |
| Phase 2 | NCT05890352 | Sep 2023 → Dec 2026 expected | high grade B-cell lymphoma, high grade B-cell lymphoma with MYC and/ or BCL2 and/or BCL6 rearrangement | SWOG Cancer Research Network | Recruiting | No outcome recorded |
| Phase 2 | NCT05821088 | Jun 2023 → Feb 2026 overdue | B-cell lymphoma, unclassifiable, with features intermediate between diffuse large b-cell lymphoma and classical Hodgkin lymphoma, T-cell/histiocyte rich large B cell lymphoma, high grade B-cell lymphoma, high grade B-cell lymphoma with MYC and/ or BCL2 and/or BCL6 rearrangement +3 | David Bond, MD | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05718869 | May 2023 → Jul 2027 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | City of Hope Medical Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05615636 | Apr 2023 → Aug 2027 expected | B-cell non-Hodgkin lymphoma, Hodgkins lymphoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05453500 | Mar 2023 → Apr 2026 overdue | B-cell acute lymphoblastic leukemia | University of Washington | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05786040 | Mar 2023 → Dec 2027 expected | post-transplant lymphoproliferative disease | Timothy Voorhees | Recruiting | No outcome recorded |
| Phase 2 | NCT05788289 | Mar 2023 → Aug 2024 | mantle cell lymphoma | Memorial Sloan Kettering Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT06465433 | Nov 2022 → Aug 2027 expected | hematopoietic and lymphoid cell neoplasm | Incyte Corporation | Recruiting | No outcome recorded |
| Phase 2 | NCT04978584 | Mar 2022 → Jan 2027 expected | diffuse large B-cell lymphoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04974216 | Dec 2021 → Jul 2024 overdue | diffuse large B-cell lymphoma | The Lymphoma Academic Research Organisation | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04646395 | Oct 2021 → Sep 2027 expected | marginal zone lymphoma | International Extranodal Lymphoma Study Group (IELSG) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05552937 | Sep 2021 → Apr 2025 overdue | diffuse large B-cell lymphoma | Beijing InnoCare Pharma Tech Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT02639910 | Nov 2016 → Nov 2018 | chronic lymphocytic leukemia/small lymphocytic lymphoma | MorphoSys AG | Completed | No outcome recorded |
| Phase 2 | NCT02399085 | Mar 2016 → Nov 2022 | diffuse large B-cell lymphoma | MorphoSys AG | Completed | No outcome recorded |
| Phase 2 | NCT02005289 | Jan 2014 → May 2025 | chronic lymphocytic leukemia/small lymphocytic lymphoma, prolymphocytic leukemia | Ohio State University Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT01685008 | Apr 2013 → Apr 2022 | non-Hodgkin lymphoma | MorphoSys AG | Completed | No outcome recorded |
| Phase 2 | NCT01685021 | Apr 2013 → Mar 2015 | acute lymphoblastic leukemia | MorphoSys AG | Terminated | No outcome recorded |
| Phase 2/31 trial · 1 missed | ||||||
| Phase 2/3 | NCT02763319 | Nov 2016 → Jun 2024 | diffuse large B-cell lymphoma | Incyte Corporation | Completed | Missed primary |
| Phase 34 trials · 2 met primary | ||||||
| Phase 3 | NCT06521255 | May 2024 → Sep 2028 expected | diffuse large B-cell lymphoma | Beijing InnoCare Pharma Tech Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT05429268 | Dec 2022 → Mar 2026 overdue | diffuse large B-cell lymphoma, large B-cell lymphoma | Incyte Corporation | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04824092 | May 2021 → Sep 2026 overdue | diffuse large B-cell lymphoma | Incyte Corporation | Active not recruiting | Met primary |
| Phase 3 | NCT04680052 | Apr 2021 → Feb 2024 overdue | follicular lymphoma, marginal zone lymphoma | Incyte Corporation | Active not recruiting | Met primary |
| Phase not stated1 trial | ||||||
| — | NCT04300803 | — | diffuse large B-cell lymphoma | MorphoSys AG | Approved for marketing | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 1 | NCT07225439 Background | Sep 2026 → Dec 2027 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular lymphoma, high grade B-cell lymphoma, mantle cell lymphoma +2 | Paolo Caimi, MD | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05205252 Comparator | Dec 2021 → Jul 2023 | refractory hematologic cancer | Epizyme, Inc. | Withdrawn | No outcome recorded Stop: Business |
| Phase 1/2 | NCT04882163 Background | Oct 2021 → Apr 2026 | B-cell non-Hodgkin lymphoma | Celgene Corporation | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT05328102 Background | Apr 2022 → Feb 2023 | diffuse large B-cell lymphoma | Xencor, Inc. | Terminated | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 39
| Date | Issuer | Release |
|---|---|---|
| 2026-06-19 | Incyte Corporation | Regulatory Incyte Japan Announces Approval of Minjuvi® (tafasitamab) in Combination with Lenalidomide for the Treatment of Adults with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) incyte.com ↗
Incyte Biosciences Japan G.K. today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Minjuvi® (tafasitamab) in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). |
| 2026-06-18 | Beijing InnoCare Pharma Tech Co., Ltd. | Results 2026 EHA | 坦昔妥单抗联合疗法治疗初治DLBCL的Ⅲ期研究显示无进展生存期显著延长 innocarepharma.com ↗
在疗效方面，中位随访35.2个月后，相较R-CHOP方案，Tafa-Len-R-CHOP可使疾病进展或死亡风险降低 25%（HR=0.75，P=0.0194），2年PFS率提升 8.2%，3年PFS率提升 6.6%，达到主要终点。 |
| 2026-06-13 | Incyte Corporation | Results Results from Incyte’s Pivotal Phase 3 frontMIND Trial of Tafasitamab (Monjuvi®/Minjuvi®) Combination Presented at the 2026 European Hematology Association (EHA) Congress Plenary Showed Prolonged Progression Free Survival incyte.com ↗
Results showed tafasitamab and lenalidomide plus R-CHOP (Tafa-Len-R-CHOP) significantly prolonged progression-free survival (PFS), reducing risk of disease progression or death by 25% |
| 2026-05-30 | Incyte Corporation | Results Incyte’s Pivotal frontMIND Trial Showed Tafasitamab (Monjuvi®/Minjuvi®) Combination Significantly Prolonged Progression-free Survival, Reducing the Risk of Disease Progression or Death by 25% in Patients with Previously Untreated, High-risk DLBCL incyte.com ↗ |
| 2026-01-05 | Incyte Corporation | Results Incyte Announces Positive Topline Results from Pivotal Study of Tafasitamab (Monjuvi®/Minjuvi®) as a First-line Treatment for Diffuse Large B-Cell Lymphoma incyte.com ↗
The trial met its primary endpoint of progression-free survival (PFS) by investigator assessment (Hazard Ratio 0.75 [0.59,0.96]; p-value 0.019), according to Lugano 2014 criteria. |
| 2025-12-22 | Incyte Corporation | Regulatory Incyte Japan Announces Approval of Minjuvi® (tafasitamab) in Combination with Rituximab and Lenalidomide for the Treatment of Relapsed or Refractory Follicular Lymphoma incyte.com ↗
Incyte Biosciences Japan G.K. today announced approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for Minjuvi® (tafasitamab) in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma (2L+ FL). |
| 2025-12-17 | Incyte Corporation | Regulatory Incyte Announces European Commission Approval of Minjuvi® (tafasitamab) for the Treatment of Relapsed or Refractory Follicular Lymphoma incyte.com ↗
Incyte (Nasdaq:INCY) today announced that the European Commission (EC) has approved Minjuvi® (tafasitamab) in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one line of systemic therapy. |
| 2025-11-17 | Incyte Corporation | Regulatory Incyte Announces Positive CHMP Opinion for Minjuvi® (tafasitamab) for the Treatment of Relapsed or Refractory Follicular Lymphoma (FL) incyte.com ↗
The positive CHMP opinion is an encouraging step in our ongoing efforts to advance treatments that address critical gaps for patients. |
| 2025-10-17 | Beijing InnoCare Pharma Tech Co., Ltd. | Results 诺诚健华多项研究数据在2025年欧洲肿瘤内科学会（ESMO）年会上公布 innocarepharma.com ↗
研究结果表明，坦昔妥单抗联合来那度胺治疗DLBCL患者的有效性和安全性优于格菲妥单抗。 |
| 2025-06-18 | Incyte Corporation | Regulatory Incyte Announces FDA Approval of Monjuvi® (tafasitamab-cxix) in Combination with Rituximab and Lenalidomide for Patients with Relapsed or Refractory Follicular Lymphoma incyte.com ↗
Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Monjuvi® (tafasitamab-cxix), a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody, in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). |
| 2025-05-21 | Beijing InnoCare Pharma Tech Co., Ltd. | Regulatory 诺诚健华宣布明诺凯®（坦昔妥单抗）联合来那度胺在中国获批治疗复发/难治性弥漫性大B细胞淋巴瘤 innocarepharma.com ↗
今天宣布，靶向CD19单抗明诺凯®（坦昔妥单抗tafasitamab）联合来那度胺创新疗法获得中国国家药品监督管理局（NMPA）批准，用于治疗复发/难治性弥漫性大B细胞淋巴瘤（R/R DLBCL）成人患者。 |
| 2024-12-10 | Incyte Corporation | Results Incyte Late-Breaking Tafasitamab (Monjuvi®) Data at ASH 2024 Demonstrate Significantly Improved Progression-Free Survival in Patients with Relapsed or Refractory Follicular Lymphoma incyte.com ↗
The late-breaking results, which build on previously announced topline data, show that the study met its primary endpoint by demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) by investigator assessment in 548 patients with FL. |
| 2024-08-15 | Incyte Corporation | Results Incyte Announces Positive Topline Results from Pivotal Study of Tafasitamab (Monjuvi®) in Relapsed or Refractory Follicular Lymphoma incyte.com ↗
The trial met its primary endpoint of progression free survival (PFS) by investigator assessment in FL. |
| 2024-06-20 | Beijing InnoCare Pharma Tech Co., Ltd. | Regulatory 诺诚健华坦昔妥单抗联合来那度胺治疗复发/难治DLBCL的上市申请在中国获受理 innocarepharma.com ↗
坦昔妥单抗治疗方案上市申请获受理是诺诚健华发展历程中的又一重要里程碑。 |
| 2024-01-22 | Beijing InnoCare Pharma Tech Co., Ltd. | Regulatory 诺诚健华宣布坦昔妥单抗联合来那度胺治疗复发/难治DLBCL在大湾区开出首方 innocarepharma.com ↗
坦昔妥单抗 (Tafasitamab, Minjuvi®) 联合来那度胺近日已获广东省药品监督管理局批准，在大湾区用于治疗不适合自体干细胞移植 (ASCT) 条件的复发/难治弥漫性大B细胞淋巴瘤（DLBCL）成人患者。 |
| 2023-04-23 | Beijing InnoCare Pharma Tech Co., Ltd. | Results 诺诚健华合作伙伴宣布L-MIND 五年研究结果显示Tafasitamab 为R/R DLBCL 患者提供长期且持久的缓解 innocarepharma.com ↗
今天宣布，其合作伙伴Incyte携手MorphoSys联合公布了 L-MIND II 期研究的最终五年随访数据，显示tafasitamab联合来那度胺，之后tafasitamab 单药治疗，为复发/难治性弥漫性大 B 细胞淋巴瘤 (R/R DLBCL) 成人患者提供了长期且持久的缓解。 |
| 2023-04-17 | Beijing InnoCare Pharma Tech Co., Ltd. | Results 诺诚健华多项肿瘤管线数据在2023年美国癌症研究协会（AACR）年会上公布 innocarepharma.com ↗
在各种临床前模型中确认奥布替尼联合tafasitamab和来那度胺的协同作用，为临床研究中的联合治疗提供了科学依据。 |
| 2023-04-16 | Incyte Corporation | Results MorphoSys and Incyte Announce Five-Year Results of L-MIND Study Showed Prolonged, Durable Responses in Relapsed or Refractory DLBCL Patients Treated with Monjuvi® (tafasitamab-cxix) incyte.com ↗
The prolonged and durable responses seen at five years among relapsed or refractory DLBCL patients in the L-MIND study show that the Monjuvi treatment regimen may have curative potential, which I look forward to seeing explored in future studies. |
| 2022-12-27 | Beijing InnoCare Pharma Tech Co., Ltd. | Regulatory 诺诚健华宣布Tafasitamab联合来那度胺在香港获批用于治疗复发/难治性弥漫性大B细胞淋巴瘤 innocarepharma.com ↗
2022年12月28日，中国北京——生物医药高科技公司诺诚健华（上交所代码：688428；香港联交所代码：09969）今天宣布，tafasitamab联合来那度胺已获香港卫生署批准，用于治疗不适合自体干细胞移植条件的复发/难治性弥漫性大B细胞淋巴瘤（DLBCL）成人患者。 |
| 2022-12-20 | Beijing InnoCare Pharma Tech Co., Ltd. | Regulatory 诺诚健华宣布奥布替尼联合Tafasitamab和来那度胺在中国获批开展II期临床试验 innocarepharma.com ↗
2022年12月21日，中国北京——诺诚健华（上交所代码：688428；香港联交所代码：09969）今日宣布，奥布替尼（宜诺凯®）联合tafasitamab (Minjuvi®)和来那度胺已在中国获批开展单臂、开放标签、多队列II期临床试验，旨在评估其治疗复发/难治性非霍奇金淋巴瘤（NHL）患者的有效性和安全性。 |
| 2022-10-06 | Knight Therapeutics (USA) Inc | Regulatory Knight Therapeutics Announces Regulatory Submission for Tafasitamab in Brazil knighttx.com ↗
Knight Therapeutics Inc., (TSX: GUD) (“Knight”) a pan-American (ex-USA) specialty pharmaceutical company, announced today that its Brazilian affiliate, United Medical Ltd., has submitted a marketing authorization application for tafasitamab in combination with lenalidomide to ANVISA, the Brazilian health regulatory agency, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplantation (ASCT). |
| 2022-08-30 | Beijing InnoCare Pharma Tech Co., Ltd. | Regulatory 诺诚健华宣布Tafasitamab联合来那度胺治疗复发/难治DLBCL的上市申请获香港受理 innocarepharma.com ↗
2022年8月31日，中国北京——生物医药高科技公司诺诚健华（香港联交所代码：09969）今天宣布，tafasitamab联合来那度胺治疗不适合自体干细胞移植条件的复发/难治弥漫性大B细胞淋巴瘤（DLBCL）成人患者的生物制品许可申请（BLA）已获香港卫生署受理。 |
| 2022-07-21 | Beijing InnoCare Pharma Tech Co., Ltd. | Regulatory 诺诚健华宣布Tafasitamab联合来那度胺治疗复发/难治DLBCL在博鳌乐城开出首方 innocarepharma.com ↗
2022年7月22日，中国北京——诺诚健华（香港联交所代码：09969）今天宣布tafasitamab (Minjuvi®)联合来那度胺已获海南省卫健委和药监局批准，在海南博鳌乐城国际医疗旅游先行区用于治疗不适合自体干细胞移植 (ASCT) 条件的复发/难治弥漫性大B细胞淋巴瘤（DLBCL）成人患者。 |
| 2022-05-25 | Beijing InnoCare Pharma Tech Co., Ltd. | Regulatory 诺诚健华宣布Tafasitamab联合来那度胺在中国获批II期临床研究 innocarepharma.com ↗
2022年5月26日，中国北京——生物医药高科技公司诺诚健华（香港联交所代码：09969）今天宣布，tafasitamab联合来那度胺已经获得中国国家药品监督管理局（NMPA）批准开展单臂、开放、多中心临床II期研究。 |
| 2021-12-11 | Incyte Corporation | Results MorphoSys and Incyte Announce Additional Real-World Evidence Results from RE-MIND2 Study of Tafasitamab (Monjuvi®) in Combination with Lenalidomide for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma incyte.com ↗ |
| 2021-08-26 | Incyte Corporation | Regulatory Incyte and MorphoSys Announce the European Commission Approval of Minjuvi® (tafasitamab) in Combination With Lenalidomide for the Treatment of Adults With Relapsed or Refractory Diffuse Large B-Cell Lymphoma incyte.com ↗ |
| 2021-06-25 | Incyte Corporation | Regulatory Incyte and MorphoSys Announce Positive CHMP Opinion for Tafasitamab in Combination with Lenalidomide for the Treatment of Adults with Relapsed or Refractory Diffuse Large B-Cell Lymphoma incyte.com ↗ |
| 2021-06-04 | Incyte Corporation | Results Incyte and MorphoSys Announce Three-Year Results from Phase 2 L-MIND Study of Tafasitamab in Combination with Lenalidomide for the Treatment of Relapsed or Refractory DLBCL incyte.com ↗
Incyte (NASDAQ:INCY) and MorphoSys US Inc., a fully owned subsidiary of MorphoSys AG (FSE: MOR; NASDAQ:MOR), today announced new three-year follow-up data from the ongoing Phase 2 L-MIND study of tafasitamab (Monjuvi®) in combination with lenalidomide in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). |
| 2020-12-07 | Incyte Corporation | Results Data Evaluating Tafasitamab with and without Lenalidomide in Combination with R-CHOP in Patients with DLBCL Presented at ASH 2020 incyte.com ↗
The preliminary results of firstMIND indicate that tafasitamab plus lenalidomide in addition to R-CHOP shows an acceptable tolerability profile. |
| 2020-07-31 | Xencor, Inc. | Regulatory Xencor Earns Milestone Payment from MorphoSys for FDA Approval of Monjuvi® (tafasitamab-cxix) in the United States xencor.com ↗
Xencor has earned a $25 million milestone payment from MorphoSys under the license agreement between the companies for Monjuvi in connection with the regulatory approval. |
| 2020-07-31 | Incyte Corporation | Regulatory FDA Approves Monjuvi® (tafasitamab-cxix) in Combination With Lenalidomide for the Treatment of Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) incyte.com ↗
The FDA decision represents the first approval of a second-line treatment for adult patients who progressed during or after first-line therapy. |
| 2020-05-20 | Incyte Corporation | Regulatory Incyte and MorphoSys Announce the Validation of the European Marketing Authorization Application for Tafasitamab incyte.com ↗
Incyte (NASDAQ:INCY) and MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ:MOR) today announced the validation of the European Marketing Authorization Application (MAA) for tafasitamab, an anti-CD19 antibody. |
| 2020-05-14 | Incyte Corporation | Results MorphoSys and Incyte Announce Long-term Follow-up Results from L-MIND Study of Tafasitamab in Patients with r/r DLBCL incyte.com ↗
Assessment by an independent review committee (IRC) at data cut-off showed an objective response rate (ORR) of 58.8% (47 out of 80 patients) and a complete response (CR) rate of 41.3% (33 out of 80 patients). |
| 2014-12-06 | Xencor, Inc. | Results MorphoSys and Xencor Publish Final Results from Phase 1/2a Trial of MOR208 (XmAb5574) in CLL/SLL at ASH Annual Meeting xencor.com ↗
The results demonstrate that the drug was well tolerated and achieved durable responses in a high risk and poor prognosis patient population with significant progression-free survival achieved: |
| 2013-10-07 | Xencor, Inc. | Results MorphoSys and Xencor Provide Update on Phase 1/2a Trial in CLL/SLL for MOR208 (XmAb5574) xencor.com ↗
The final study results including the extended treatment arm showed an overall response rate of 29.6% (according to IWCLL 2008 criteria) based on the safety population of the trial (n=27) up from the previously reported 14.8%. |
| 2012-11-05 | Xencor, Inc. | Results MorphoSys and Xencor Report Clinical Data for MOR208/XmAb5574 - Phase 1/2a Trial in CLL/SLL Patients Met Primary and Secondary Objectives xencor.com ↗
MOR208 showed encouraging signs of preliminary anti-tumor activity and an acceptable safety and tolerability profile in patients with high-risk, heavily pretreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). |
| 2008-12-09 | Xencor, Inc. | Results Xencor Presents Data from Pre-clinical Studies of its Anti-CD19 and Anti-CD40 Antibodies at the 50th Annual Meeting of the American Society of Hematology xencor.com ↗
In the studies, treatment with XmAb5574 achieved near complete elimination of B cells in cynomolgus monkeys, complementing previous data showing strong antitumor potency and anti-proliferative apoptotic activity similar to that of rituximab. |
| 2008-06-01 | Xencor, Inc. | Results Xencor to Present New Data from Anti-CD19 Antibody Program at ASCO xencor.com ↗
Additionally, the pharmacokinetics of XmAb5574 were shown to be indistinguishable from that of the 1gG1 analog. |
| 2008-04-15 | Xencor, Inc. | Results Xencor Presents Pre-Clinical Data for Anti-CD19 Antibody at AACR xencor.com ↗
In the studies, XmAb5574 demonstrated enhanced anti-tumor activity in vitro and in vivo, and caused sustained B cell depletion in cynomolgus monkeys. |
All press releases naming this drug 55 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 58 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | tafasitamab | “Eligible patients with transplant-eligible relapsed/refractory DLBCL will receive 2-4 cycles (21 days per cycle) of tafasitamab combined with lenalidomide and standard...” NCT07621406 ↗51“A phase 2a, single-arm, open-label study of tafasitamab, a humanized, Fc-modified, anti-CD19 antibody, in patients with relapsed/refractory B-precursor cell acute lymphoblastic...” PMID 34343354 ↗ Aug 2021 “Tafasitamab will be administered intravenously at protocol defined timepoints.” NCT07104565 ↗ |
| Known as | Minjuvi | “Tafasitamab (Minjuvi®)” NCT05583071 ↗ |
| Known as | Monjuvi | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298047 ↗ |
| Known as | Monjuvi (tafasitamab-cxix) for injection | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298047 ↗ |
| Known as | MOR00208 | “XmAb5574 (aka MOR00208) is a novel humanized CD19 monoclonal antibody with an engineered Fc region to enhance Fcγ receptor binding affinity.” PMID 25301708 ↗ Oct 20144“Expanded Access Program for Tafasitamab (MOR00208) in R/R DLBCL” NCT04300803 ↗ |
| Known as | MOR208 | “An Expanded Access Protocol to Provide Intermediate Access to Tafasitamab (MOR208) for the Combination Treatment With Lenalidomide to Patients With Relapsed or Refractory...” NCT04300803 ↗ |
| Known as | Tafa | “Participants in this group will receive combination therapy of Zanubrutinib (Zanu) and Tafasitamab (Tafa) for up to 24 cycles, followed by maintenance therapy with Zanubrutinib...” NCT06029309 ↗ |
| Known as | Tafasitamab cxix | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298047 ↗ |
| Known as | Xmab5574 | “Drug: MOR00208 (formerly Xmab5574)” NCT01685021 ↗ |
| Action | Deplete | “Tafasitamab produced rapid B-cell/blast depletion in 21 of 22 patients within 1 to 2 weeks of first administration.” PMID 34343354 ↗ Aug 2021 |
| Modality | Monoclonal antibody | “XmAb5574 (aka MOR00208) is a novel humanized CD19 monoclonal antibody with an engineered Fc region to enhance Fcγ receptor binding affinity.” PMID 25301708 ↗ Oct 2014 |
| Route | Intravenous | “Intravenous infusion of XmAb5574 administered weekly during two 28-day cycles with an additional dose being administered during the first week of Cycle 1.” NCT01161511 ↗ |
| Target | CD19 | “human anti-CD19 antibody MOR00208” NCT01685008 ↗ |