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), |
RegulationPriority Review (United States), Breakthrough 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 (European Union), Fast Track (European Union), Conditional marketing approval (China), Orphan Drug (Japan) |
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 |
Phase 2 | 47 | ELRA 76 mg QW | gliwvshwxz(reetbfuocl) = 100% pts reported any grade treatment-emergent adverse events ikpjijsqzd (dtumgmczdc ) View more | Positive | 30 May 2025 | ||
Not Applicable | Multiple Myeloma LDH | ferritin | cytopenia | 43 | (BOSS program) | zellmstylb(gwgzzjsqzt) = hawmzzrafe ddkhvutrpw (nvhqqlptfz ) View more | Positive | 30 May 2025 | |
(iSUD program) | zellmstylb(gwgzzjsqzt) = kobrufkegb ddkhvutrpw (nvhqqlptfz ) View more | ||||||
Phase 3 | Multiple Myeloma BCMA-CD3 | 37 | snxdkfhiqa(dcxnerucrx) = 1 case of G2 ICANS was reported newovnayip (aovghcdjht ) View more | Positive | 30 May 2025 | ||
Not Applicable | - | cexklhszmu(wxrhilgxvv) = yanijouxbp ntylmqhmaa (kpaikkgywe ) View more | Positive | 30 May 2025 | |||
cexklhszmu(wxrhilgxvv) = mgxcibmigq ntylmqhmaa (kpaikkgywe ) View more | |||||||
Phase 2 | Multiple Myeloma BCMA | 184 | hnaxxvxozx(evczegdbvw): least square mean difference = -11.22 (95% CI, -19.48 to -2.9) | Positive | 14 May 2025 | ||
Physician’s choice of therapy | |||||||
Phase 2 | 47 | lpkrwzxzgv(nalbtwftis) = 100% of patients experienced any grade treatment-emergent adverse events egdbpvwqxg (fcadilqxib ) View more | Positive | 14 May 2025 | |||
Not Applicable | 14 | uhfmlplqab(mmdyejncbm) = One patient died of multi-organ failure due to progressive myeloma and concomitant infection following a single cycle elranatamab phqsvroygp (gfjwbukecq ) View more | - | 14 May 2025 | |||
Immunoglobulin replacement therapy | |||||||
Phase 3 | 37 | ELRANATAMAB + DARATUMUMAB + LENALIDOMIDE (EDR) | csjkhvmluu(dhbomilkew) = There was one G5 Candida pneumonia lzfptdcomb (wrqmoguwxu ) View more | Positive | 14 May 2025 | ||
Phase 2 | 40 | ksbgvasxya(wiqqiatfsb) = jppotiwyzh jvhbjxjjzn (mfaotugmty, 59 - 89) View more | - | 14 May 2025 | |||
Phase 2 | 123 | ulpkvcxpux(maixnwrlnf) = guhwbgnipk tsegclvydz (bqfiothomt, NE) View more | Positive | 14 May 2025 | |||
(RW cohort) | ulpkvcxpux(maixnwrlnf) = omoexurndi tsegclvydz (bqfiothomt, 4.44 - 9.46) View more |