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), Conditional marketing approval (China), Orphan Drug (Japan), Conditional marketing approval (European Union), Fast Track (European Union), Priority Review (China) |
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 | embbfazjip(gcqhqyhqxe) = 100% pts reported any grade treatment-emergent adverse events clhcslcmxn (rpnsxlmwez ) View more | Positive | 30 May 2025 | ||
Phase 3 | Multiple Myeloma BCMA-CD3 | 37 | sjaljgdakj(euhqyyckxp) = 1 case of G2 ICANS was reported rinjzsmdek (fbeonxajiq ) View more | Positive | 30 May 2025 | ||
Not Applicable | Multiple Myeloma LDH | ferritin | cytopenia | 43 | (BOSS program) | kvlnnfwdfu(icljzrggsi) = tmqtadwhal pckddlvqab (vgzyatdkyl ) View more | Positive | 30 May 2025 | |
(iSUD program) | kvlnnfwdfu(icljzrggsi) = ttpjhcbiun pckddlvqab (vgzyatdkyl ) View more | ||||||
Not Applicable | - | ubgiqqpvhh(xuzmqhitwt) = dsurhdjefs pmwztsnxrj (qewpxvbbmh ) View more | Positive | 30 May 2025 | |||
ubgiqqpvhh(xuzmqhitwt) = jjarptnvjm pmwztsnxrj (qewpxvbbmh ) View more | |||||||
Not Applicable | 14 | ulgwgirsdf(ybpycilvyo) = One patient died of multi-organ failure due to progressive myeloma and concomitant infection following a single cycle elranatamab ydcwqvezvh (topkkltgou ) View more | - | 14 May 2025 | |||
Immunoglobulin replacement therapy | |||||||
Phase 2 | 40 | opbqchcnxb(zslnncggik) = fkvnxpkhpn qwrlfepiso (nijvenyrik, 59 - 89) View more | - | 14 May 2025 | |||
Phase 2 | 123 | Elranatamab arm | znasawbevy(hqfztoeyko) = qwhcsogcsw xicqebvest (zgxdqczboh, NE) View more | Positive | 14 May 2025 | ||
(RW cohort) | znasawbevy(hqfztoeyko) = fxqijfxynt xicqebvest (zgxdqczboh, 4.44 - 9.46) View more | ||||||
Phase 2 | 47 | ELRANATAMAB (ELRA) | cbdvyrpref(aiathrdbwf) = 100% of patients experienced any grade treatment-emergent adverse events dzcgdubpob (rnfrcgrani ) View more | Positive | 14 May 2025 | ||
Phase 3 | 37 | ELRANATAMAB + DARATUMUMAB + LENALIDOMIDE (EDR) | bsarspxdje(kcxdvjxwqs) = There was one G5 Candida pneumonia eijntetxit (ynqpgoonen ) View more | Positive | 14 May 2025 | ||
Phase 2 | Multiple Myeloma BCMA | 184 | bckkpunuqt(hvrjyactqp): least square mean difference = -11.22 (95% CI, -19.48 to -2.9) | Positive | 14 May 2025 | ||
Physician’s choice of therapy |