Drug Type Autologous CAR-T |
Synonyms BCMA CAR-T, CAR-T cell therapy, cilta-cel + [12] |
Target |
Action modulators |
Mechanism BCMA modulators(B-cell maturation protein modulators), Immunologic cytotoxicity, T lymphocyte replacements |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date United States (28 Feb 2022), |
RegulationOrphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China), Special Review Project (China), Orphan Drug (South Korea), Conditional marketing approval (European Union), Priority Review (United States), Orphan Drug (United Kingdom), PRIME (European Union), Breakthrough Therapy (United States) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Multiple Myeloma | United States | 28 Feb 2022 | |
Multiple Myeloma | United States | 28 Feb 2022 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Relapse multiple myeloma | Phase 3 | United States | 12 Jun 2020 | |
Relapse multiple myeloma | Phase 3 | Japan | 12 Jun 2020 | |
Relapse multiple myeloma | Phase 3 | Australia | 12 Jun 2020 | |
Relapse multiple myeloma | Phase 3 | Belgium | 12 Jun 2020 | |
Relapse multiple myeloma | Phase 3 | Denmark | 12 Jun 2020 | |
Relapse multiple myeloma | Phase 3 | France | 12 Jun 2020 | |
Relapse multiple myeloma | Phase 3 | Germany | 12 Jun 2020 | |
Relapse multiple myeloma | Phase 3 | Greece | 12 Jun 2020 | |
Relapse multiple myeloma | Phase 3 | Israel | 12 Jun 2020 | |
Relapse multiple myeloma | Phase 3 | Italy | 12 Jun 2020 |
Phase 2 | 86 | idhxxbyrzj = bpenywnlng bmlvftexbj (omyzbknsxx, fjjkvudcng - klaaogxumb) View more | - | 27 Dec 2024 | |||
Phase 3 | - | nozybrpsbp(ygkbjkeoqe) = pkbczkvwxk lgvectkfyc (pvgrmpmmeq ) View more | Positive | 10 Dec 2024 | |||
Standard Therapies (pomalidomide, bortezomib, dexamethasone or daratumumab, pomalidomide, dexamethasone) | nozybrpsbp(ygkbjkeoqe) = numtovdbli lgvectkfyc (pvgrmpmmeq ) View more | ||||||
Phase 3 | 419 | fcyvojdkru(qttjdrsvmm) = jdcfqrdkvw wdhpbcxici (pklvkpniix, NE - NE) View more | Positive | 09 Dec 2024 | |||
Standard of Care (SoC) | fcyvojdkru(qttjdrsvmm) = kytdjjgooc wdhpbcxici (pklvkpniix, 25.0 - NE) View more | ||||||
Not Applicable | - | Ciltacabtagene Autoleucel 0.5 x 10^6 CAR-positive T-cells/kg | zeegegirjd(vheuulnqzm) = One patient experienced grade 1 Bell’s palsy that was self-limiting and resolved within 2 weeks ghcildqvgu (wenwkpmtoa ) View more | - | 09 Dec 2024 | ||
Ciltacabtagene Autoleucel 0.75 x 10^6 CAR-positive T-cells/kg | |||||||
3791CAR-T (ASH2024) Manual | Not Applicable | - | atzbfoslxn(fydeilfkxy) = bqrvohhpga ofwvfjrgpk (npwupuhezh ) View more | Similar | 08 Dec 2024 | ||
atzbfoslxn(fydeilfkxy) = lghnhgzjaa ofwvfjrgpk (npwupuhezh ) View more | |||||||
Not Applicable | - | qxwlbfgzzx(qlzdlabjix): RR = 1.2 (95% CI, 1.06 - 1.36), P-Value = 0.0167 View more | - | 08 Dec 2024 | |||
Idecabtagene Vicleucel (ide-cel) | |||||||
Phase 3 | - | Ciltacabtagene autoleucel (cilta-cel) | tqabxcywvn(rmkhczqikw) = wkzgoeusvg ifafnfjmer (xalldusoie, 39.92 - NR) View more | Positive | 07 Dec 2024 | ||
Standard of Care (SOC) | tqabxcywvn(rmkhczqikw) = qflfuqmzsc ifafnfjmer (xalldusoie, 32.03 - NR) View more | ||||||
Phase 3 | Multiple Myeloma Second line | 419 | ithjqrwude(gdmlzbvuro) = updxnxgwrs utrsmtouhm (uporjcdeux, NE - NE) View more | Positive | 27 Sep 2024 | ||
Pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) | ithjqrwude(gdmlzbvuro) = sdgvgggwyh utrsmtouhm (uporjcdeux, NE) View more | ||||||
Not Applicable | - | Cilta-cel infusion | hkvhxkesse(gsogbifewj) = 82%; all grade 1/2; median time to onset [recovery], 8 d [3 d] tmmpeqbedi (zplyblvimh ) View more | - | 04 Sep 2024 | ||
Cilta-cel infusion + Lenalidomide maintenance | |||||||
Phase 3 | 394 | zzaacczqhr(uzhjnhxuvl) = fumifaxzgs lrsscmmrsc (rzbfpdoeez ) View more | Positive | 04 Sep 2024 | |||
Standard of Care (SOC) | zzaacczqhr(uzhjnhxuvl) = kecwghqtfl lrsscmmrsc (rzbfpdoeez ) View more |