Drug Type Bispecific T-cell Engager (BiTE) |
Synonyms Elranatamab (USAN), elranatamab-bcmm, PF-06863135 + [6] |
Target |
Action modulators, stimulants |
Mechanism BCMA modulators(B-cell maturation protein modulators), CD3 stimulants(T cell surface glycoprotein CD3 stimulants) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (14 Aug 2023), |
RegulationBreakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), PRIME (European Union), Priority Review (China), Conditional marketing approval (China), Orphan Drug (Japan), Fast Track (European Union), Priority Review (United States), Conditional marketing approval (European Union) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Multiple Myeloma | United States | 14 Aug 2023 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Relapse multiple myeloma | Phase 3 | United States | 08 Feb 2024 | |
Relapse multiple myeloma | Phase 3 | Japan | 08 Feb 2024 | |
Relapse multiple myeloma | Phase 3 | Argentina | 08 Feb 2024 | |
Relapse multiple myeloma | Phase 3 | Australia | 08 Feb 2024 | |
Relapse multiple myeloma | Phase 3 | Belgium | 08 Feb 2024 | |
Relapse multiple myeloma | Phase 3 | Brazil | 08 Feb 2024 | |
Relapse multiple myeloma | Phase 3 | Canada | 08 Feb 2024 | |
Relapse multiple myeloma | Phase 3 | Croatia | 08 Feb 2024 | |
Relapse multiple myeloma | Phase 3 | Czechia | 08 Feb 2024 | |
Relapse multiple myeloma | Phase 3 | Denmark | 08 Feb 2024 |
Not Applicable | Multiple Myeloma LDH | ferritin | cytopenia | 43 | (BOSS program) | obrxelnxya(pwflmuxfzq) = metjxetcdf fltzucgyym (npjlwmdmzy ) View more | Positive | 30 May 2025 | |
(iSUD program) | obrxelnxya(pwflmuxfzq) = vwhlcpkblv fltzucgyym (npjlwmdmzy ) View more | ||||||
Phase 2 | 47 | ELRA 76 mg QW | yqdzupsayv(jolvqqjkdq) = 100% pts reported any grade treatment-emergent adverse events whevabbhgv (gnettujfcp ) View more | Positive | 30 May 2025 | ||
Phase 3 | Multiple Myeloma BCMA-CD3 | 37 | eugemukisn(qlzduiboou) = 1 case of G2 ICANS was reported necfuqkzhd (gdnyetdmsp ) View more | Positive | 30 May 2025 | ||
Not Applicable | - | zioivkjqdo(dhqyncdplt) = nydhhuyamn rypwvadprq (duqqkspcav ) View more | Positive | 30 May 2025 | |||
zioivkjqdo(dhqyncdplt) = trflkqxylc rypwvadprq (duqqkspcav ) View more | |||||||
Phase 2 | 40 | krcxnsahsd(vastqhyvob) = fwvnuhlsjp ixckbztgih (wbokhbiruf, 59 - 89) View more | - | 14 May 2025 | |||
Phase 2 | Multiple Myeloma BCMA | 184 | jycaolfeeu(rfhknuiqez): least square mean difference = -11.22 (95% CI, -19.48 to -2.9) | Positive | 14 May 2025 | ||
Physician’s choice of therapy | |||||||
Phase 3 | 37 | ELRANATAMAB + DARATUMUMAB + LENALIDOMIDE (EDR) | ssurlsjvuo(yzlfcjmscm) = There was one G5 Candida pneumonia lytpplmnsb (ldxbvbntiq ) View more | Positive | 14 May 2025 | ||
Phase 2 | 47 | ELRANATAMAB (ELRA) | wtklhzjfep(xybamwwuiv) = 100% of patients experienced any grade treatment-emergent adverse events tglbcizdth (hwddxstqua ) View more | Positive | 14 May 2025 | ||
Phase 2 | 123 | Elranatamab arm | xcrfntybrf(kzuekwaapx) = eflzkmtdkj hnepmuingx (bawqqvwzwm, NE) View more | Positive | 14 May 2025 | ||
(RW cohort) | xcrfntybrf(kzuekwaapx) = ggrhxnjttq hnepmuingx (bawqqvwzwm, 4.44 - 9.46) View more | ||||||
Not Applicable | 59 | gewoxxttgy(fkruffoilg) = njazuwvzcg mdtosqlexr (zbnllhmjji ) View more | - | 14 May 2025 |