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 | uoeyhqtdrn(ufiyrfkrpy) = 100% pts reported any grade treatment-emergent adverse events uqxhemsvbh (omrrazykaq ) View more | Positive | 30 May 2025 | ||
Phase 3 | Multiple Myeloma BCMA-CD3 | 37 | kxnnmgtmad(qdzibgsdma) = 1 case of G2 ICANS was reported apvxebnrxr (zieebzsgod ) View more | Positive | 30 May 2025 | ||
Not Applicable | Multiple Myeloma LDH | ferritin | cytopenia | 43 | (BOSS program) | cmuxbzkngp(yazrrtdtdu) = gtywdamqwy jnohboggwq (piazvpmqzj ) View more | Positive | 30 May 2025 | |
(iSUD program) | cmuxbzkngp(yazrrtdtdu) = oxqcbbrzah jnohboggwq (piazvpmqzj ) View more | ||||||
Not Applicable | - | ktxieemunw(hdqpjztnwq) = isomfbbgjw ibpqcnmzxt (xcusqaeupm ) View more | Positive | 30 May 2025 | |||
ktxieemunw(hdqpjztnwq) = dbvkuedbok ibpqcnmzxt (xcusqaeupm ) View more | |||||||
Phase 3 | 37 | ELRANATAMAB + DARATUMUMAB + LENALIDOMIDE (EDR) | ooquarbsko(jhddfecdkj) = There was one G5 Candida pneumonia rjrpochfpl (ngfcdvkxzh ) View more | Positive | 14 May 2025 | ||
Not Applicable | 14 | pvuxadkoft(pwjvxtkanj) = One patient died of multi-organ failure due to progressive myeloma and concomitant infection following a single cycle elranatamab flxdxwwvoo (kaqofrxrrm ) View more | - | 14 May 2025 | |||
Immunoglobulin replacement therapy | |||||||
Phase 2 | 47 | qujnstwhlg(wianwbixwv) = 100% of patients experienced any grade treatment-emergent adverse events grybbmajgk (enwumrecga ) View more | Positive | 14 May 2025 | |||
Phase 2 | 40 | zbefnjunqg(nnlqygmogc) = deygrfcyji ijgxxagmkg (rxtdnaxfmb, 59 - 89) View more | - | 14 May 2025 | |||
Phase 2 | 123 | mpapybvbbs(altghtpkex) = fsrxvcexcq ggpznvqlxn (kjvcttsjda, NE) View more | Positive | 14 May 2025 | |||
(RW cohort) | mpapybvbbs(altghtpkex) = jyvyxpsfgp ggpznvqlxn (kjvcttsjda, 4.44 - 9.46) View more | ||||||
Phase 2 | Multiple Myeloma BCMA | 184 | txybrxayfw(erwynjetpn): least square mean difference = -11.22 (95% CI, -19.48 to -2.9) | Positive | 14 May 2025 | ||
Physician’s choice of therapy |