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 · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved · conditional | EU (EMA) | Minjuvi | — | 2021-08-26 | europa.eu ↗ |
Trials 50 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 4 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| 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 | Not yet recruiting | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT05205252 Comparator | Dec 2021 → Jul 2023 | refractory hematologic cancer | Epizyme, Inc. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT04882163 Background | Oct 2021 → Apr 2026 | B-cell non-Hodgkin lymphoma | Celgene Corporation | Withdrawn | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05328102 Background | Apr 2022 → Feb 2023 | diffuse large B-cell lymphoma | Xencor, Inc. | Terminated | No outcome recorded |
Press releases naming this drug 31 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-06-19 | Incyte Corporation | 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 ↗ |
| 2026-06-13 | Incyte Corporation | 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 ↗ |
| 2026-05-30 | Incyte Corporation | 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 ↗ |
| 2026-04-21 | Incyte Corporation | Incyte Highlights New Phase 3 Tafasitamab Data at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting incyte.com ↗ |
| 2026-01-05 | Incyte Corporation | 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 ↗ |
| 2025-12-22 | Incyte Corporation | Incyte Japan Announces Approval of Minjuvi® (tafasitamab) in Combination with Rituximab and Lenalidomide for the Treatment of Relapsed or Refractory Follicular Lymphoma incyte.com ↗ |
| 2025-12-17 | Incyte Corporation | Incyte Announces European Commission Approval of Minjuvi® (tafasitamab) for the Treatment of Relapsed or Refractory Follicular Lymphoma incyte.com ↗ |
| 2025-11-17 | Incyte Corporation | Incyte Announces Positive CHMP Opinion for Minjuvi® (tafasitamab) for the Treatment of Relapsed or Refractory Follicular Lymphoma (FL) incyte.com ↗ |
| 2025-06-18 | Incyte Corporation | Incyte Announces FDA Approval of Monjuvi® (tafasitamab-cxix) in Combination with Rituximab and Lenalidomide for Patients with Relapsed or Refractory Follicular Lymphoma incyte.com ↗ |
| 2024-12-10 | Incyte Corporation | 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 ↗ |
| 2024-11-25 | Incyte Corporation | Incyte to Spotlight New Data, Including a Late Breaking Oral Presentation for Tafasitamab in Follicular Lymphoma, at the 2024 ASH Annual Meeting incyte.com ↗ |
| 2024-08-15 | Incyte Corporation | Incyte Announces Positive Topline Results from Pivotal Study of Tafasitamab (Monjuvi®) in Relapsed or Refractory Follicular Lymphoma incyte.com ↗ |
| 2024-02-05 | Incyte Corporation | Incyte Gains Exclusive Global Development and Commercialization Rights to Tafasitamab (Monjuvi®) incyte.com ↗ |
| 2023-04-16 | Incyte Corporation | 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 ↗ |
| 2022-06-13 | Incyte Corporation | Pfizer, MorphoSys and Incyte Enter into Clinical Trial Collaboration for Monjuvi® (tafasitamab-cxix) in Combination with TTI-622, a Fusion Protein Directed Against CD47 incyte.com ↗ |
| 2021-12-11 | Incyte Corporation | 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 | 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 ↗ |
| 2021-08-16 | Incyte Corporation | Incyte and InnoCare Announce Collaboration and License Agreement for Tafasitamab in Greater China incyte.com ↗ |
| 2021-06-25 | Incyte Corporation | 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 | 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 ↗ |
| 2021-05-11 | Incyte Corporation | Incyte and MorphoSys Announce First Patient Dosed in Phase 3 frontMIND Study Evaluating Tafasitamab Combination as a First-Line Treatment for Diffuse Large B-Cell Lymphoma incyte.com ↗ |
| 2021-04-19 | Incyte Corporation | Incyte and MorphoSys Announce First Patient Dosed in Phase 3 inMIND Study Evaluating the Addition of Tafasitamab to Lenalidomide and Rituximab in Relapsed or Refractory Follicular or Marginal Zone Lymphoma incyte.com ↗ |
| 2020-12-07 | Incyte Corporation | Data Evaluating Tafasitamab with and without Lenalidomide in Combination with R-CHOP in Patients with DLBCL Presented at ASH 2020 incyte.com ↗ |
| 2020-11-11 | Incyte Corporation | Xencor, MorphoSys and Incyte Enter into Global Development Collaboration for Tafasitamab in Combination with Plamotamab incyte.com ↗ |
| 2020-09-17 | Incyte Corporation | Incyte and MorphoSys to Host Investor Event to Discuss the Unmet Need and Global Opportunities for Tafasitamab in Non-Hodgkin Lymphomas incyte.com ↗ |
| 2020-08-18 | Incyte Corporation | National Comprehensive Cancer Network® Adds Monjuvi® (tafasitamab-cxix) to its Clinical Practice Guidelines in Oncology for B-cell Lymphomas incyte.com ↗ |
| 2020-07-31 | Incyte Corporation | 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 ↗ |
| 2020-05-20 | Incyte Corporation | Incyte and MorphoSys Announce the Validation of the European Marketing Authorization Application for Tafasitamab incyte.com ↗ |
| 2020-05-14 | Incyte Corporation | MorphoSys and Incyte Announce Long-term Follow-up Results from L-MIND Study of Tafasitamab in Patients with r/r DLBCL incyte.com ↗ |
| 2020-03-03 | Incyte Corporation | MorphoSys and Incyte Announce Antitrust Clearance of Global Collaboration and License Agreement for Tafasitamab incyte.com ↗ |
| 2020-01-13 | Incyte Corporation | MorphoSys and Incyte Sign Global Collaboration and License Agreement for Tafasitamab incyte.com ↗ |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 57 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 ↗50“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 ↗ |