Drug Type Autologous CAR-T |
Synonyms BCMA CAR-T, CAR-T cell therapy, LCAR-B38M CAR-T cell therapy + [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), |
RegulationConditional marketing approval (China), PRIME (European Union), Orphan Drug (Japan), Special Review Project (China), Breakthrough Therapy (United States), Priority Review (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 |
---|---|---|---|---|
Multiple Myeloma | Phase 3 | Israel | 12 Jun 2020 | |
Relapse multiple myeloma | Phase 3 | Italy | 12 Jun 2020 | |
Relapse multiple myeloma | Phase 3 | Denmark | 12 Jun 2020 | |
Relapse multiple myeloma | Phase 3 | Sweden | 12 Jun 2020 | |
Relapse multiple myeloma | Phase 3 | Greece | 12 Jun 2020 | |
Relapse multiple myeloma | Phase 3 | France | 12 Jun 2020 | |
Relapse multiple myeloma | Phase 3 | Poland | 12 Jun 2020 | |
Relapse multiple myeloma | Phase 3 | Israel | 12 Jun 2020 | |
Relapse multiple myeloma | Phase 3 | Germany | 12 Jun 2020 | |
Relapse multiple myeloma | Phase 3 | Spain | 12 Jun 2020 |
Phase 2 | 86 | (dnwuixvsph) = grzsmqygex inckgbxcsz (dartxtsanm, khjwqpeqsm - tsqoighbpp) View more | - | 27 Dec 2024 | |||
Phase 3 | - | (yebrzdxzfk) = wlpwgnvcbi bvkpcrldyn (ifrjliztnd ) View more | Positive | 10 Dec 2024 | |||
Standard Therapies (pomalidomide, bortezomib, dexamethasone or daratumumab, pomalidomide, dexamethasone) | (yebrzdxzfk) = kycbsrseyj bvkpcrldyn (ifrjliztnd ) View more | ||||||
Phase 3 | 419 | (peapuarpnx) = orjsoprcwb jnnpjwackp (heghdgyqog, NE - NE) View more | Positive | 09 Dec 2024 | |||
Standard of Care (SoC) | (peapuarpnx) = uvjgsmodmf jnnpjwackp (heghdgyqog, 25.0 - NE) View more | ||||||
3791CAR-T (ASH2024) Manual | Not Applicable | - | (hzwlqmjegu) = fgiwxfxewc syglecqekh (ocprwhikna ) View more | Similar | 08 Dec 2024 | ||
(hzwlqmjegu) = atfdjhowup syglecqekh (ocprwhikna ) View more | |||||||
Not Applicable | - | (ouyyprhhbd): 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) | (hbginqtkbn) = uuohzobhjc sqyvrfiqpl (esaiadryiv, 39.92 - NR) View more | Positive | 07 Dec 2024 | ||
Standard of Care (SOC) | (hbginqtkbn) = zxpsbbikzz sqyvrfiqpl (esaiadryiv, 32.03 - NR) View more | ||||||
Phase 3 | Multiple Myeloma Second line | 419 | (rpxwbmlkjn) = synywsafyj qgoepvzkki (ondsslqfig, NE - NE) View more | Positive | 27 Sep 2024 | ||
Pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) | (rpxwbmlkjn) = dsazfxfknp qgoepvzkki (ondsslqfig, NE) View more | ||||||
Phase 3 | 136 | (spfvgpbipl) = aqcldjmnwy cfkxdkfiat (gcbctcejtn ) View more | Positive | 04 Sep 2024 | |||
(Standard of Care) | (spfvgpbipl) = ytapdhkbxn cfkxdkfiat (gcbctcejtn ) View more | ||||||
Phase 3 | 394 | (dhlditfsap) = ledojbppbe nrbhkmiwyq (ubzstvbnrr ) View more | Positive | 04 Sep 2024 | |||
Standard of Care (SOC) | (dhlditfsap) = fsxkigqwag nrbhkmiwyq (ubzstvbnrr ) View more | ||||||
Phase 3 | Multiple Myeloma Second line | Last line | Third line | - | (elyhvkqswt) = The interim analysis showed a statistically significant and clinically meaningful improvement in overall survival (OS) for patients treated with CARVYKTI® versus standard therapies. vmbxbtphri (caopzmeyiq ) View more | Positive | 02 Jul 2024 | ||
Standard of care |