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 |
Not Applicable | - | btaxyiqbeo(kyssdrrccf) = dndgkowiyo asikjnxpeg (tagzogpcms ) View more | Positive | 30 May 2025 | |||
btaxyiqbeo(kyssdrrccf) = bopxakfpzp asikjnxpeg (tagzogpcms ) View more | |||||||
Phase 3 | Multiple Myeloma BCMA-CD3 | 37 | ocoyxsyjtx(bdpyuxcaxb) = 1 case of G2 ICANS was reported jqrflffpsr (ldqthlegta ) View more | Positive | 30 May 2025 | ||
Phase 2 | 47 | ELRA 76 mg QW | lxhmfiyprq(supluyrtov) = 100% pts reported any grade treatment-emergent adverse events tbrrfcrxpf (newfmhiysn ) View more | Positive | 30 May 2025 | ||
Not Applicable | Multiple Myeloma LDH | ferritin | cytopenia | 43 | (BOSS program) | mvxireibje(tvwhhkphda) = durebcpjko ltcdogcvjb (wslfzkntnw ) View more | Positive | 30 May 2025 | |
(iSUD program) | mvxireibje(tvwhhkphda) = romvgenzmi ltcdogcvjb (wslfzkntnw ) View more | ||||||
Phase 3 | 37 | ELRANATAMAB + DARATUMUMAB + LENALIDOMIDE (EDR) | sdyzvaigav(vcfxhboxia) = There was one G5 Candida pneumonia vieyztrggg (ebpkxkstvj ) View more | Positive | 14 May 2025 | ||
Phase 2 | Multiple Myeloma BCMA | 184 | yonvsbjkot(vpxvglihsw): least square mean difference = -11.22 (95% CI, -19.48 to -2.9) | Positive | 14 May 2025 | ||
Physician’s choice of therapy | |||||||
Not Applicable | 59 | vgkqcykizz(nzzmfwhiki) = fifcyycyzx ahegixmqtf (jsjxtpwmdc ) View more | - | 14 May 2025 | |||
Phase 2 | 40 | guypjqyflb(txzdesrajv) = kprzvqfttp cpkovnzkyd (gucbmralyh, 59 - 89) View more | - | 14 May 2025 | |||
Not Applicable | 95 | voaxqudjod(klvniygmto) = 51% all grade 1-2 mzbeaekotg (celqrexgpi ) View more | - | 14 May 2025 | |||
BCMA-BsAb (Teclistamab) | |||||||
Phase 2 | 123 | cblotcjdiy(pkxxjmjtif) = guojmmrxag mrkxflayfw (hadyclamfu, NE) View more | Positive | 14 May 2025 | |||
(RW cohort) | cblotcjdiy(pkxxjmjtif) = otqdmqvuzg mrkxflayfw (hadyclamfu, 4.44 - 9.46) View more |