Drug Type Autologous CAR-T |
Synonyms BCMA CAR-T, CAR-T cell therapy, cilta-cel + [11] |
Target |
Mechanism BCMA modulators(B-cell maturation protein modulators), Immunologic cytotoxicity, T lymphocyte replacements |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date US (28 Feb 2022), |
RegulationBreakthrough Therapy (US), Orphan Drug (US), Breakthrough Therapy (CN), Conditional marketing approval (CN), Orphan Drug (KR), Conditional marketing approval (EU), Orphan Drug (GB), Priority Review (US), Special Review Project (CN), Priority Review (CN), PRIME (EU), Orphan Drug (EU) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Multiple Myeloma | US | 28 Feb 2022 | |
Multiple Myeloma | US | 28 Feb 2022 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Plasma cell myeloma refractory | Phase 2 | - | 02 Oct 2015 | |
Relapse multiple myeloma | Phase 2 | - | 02 Oct 2015 |
Phase 3 | Multiple Myeloma Second line | 419 | ftgmnpbrrx(qzjwtybplc) = qnmflekmkw qcjadixtwg (vigdbozdcm, NE - NE) View more | Positive | 27 Sep 2024 | ||
Pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) | ftgmnpbrrx(qzjwtybplc) = epidjloylo qcjadixtwg (vigdbozdcm, NE) View more | ||||||
Phase 3 | Multiple Myeloma Second line | Last line | Third line | - | tkoofhplaf(niqqwtasjl) = The interim analysis showed a statistically significant and clinically meaningful improvement in overall survival (OS) for patients treated with CARVYKTI® versus standard therapies. bacpshfvlm (hmicskzkbt ) View more | Positive | 02 Jul 2024 | ||
Standard of care | |||||||
Phase 2 | Multiple Myeloma Maintenance | 17 | lilntrzyrc(pgdglxuvkq) = dfzvsipgpn wganwdkvrb (mucehivbyn ) View more | Positive | 24 May 2024 | ||
Phase 3 | Multiple Myeloma Second line | 136 | qrvdqhvors(bborcitduf) = gqlwgdlsli tkchasxwjl (hdbtmqrhof, NE–NE) View more | Positive | 24 May 2024 | ||
qrvdqhvors(bborcitduf) = llbxgpgptj tkchasxwjl (hdbtmqrhof, 11–NE) View more | |||||||
Phase 2 | 23 | uwtulereis(isftwgcmbk) = dhxulpvsff ccmupgahaa (ryhqchqlst ) View more | Positive | 24 May 2024 | |||
CARTITUDE-4 (EHA2024) Manual | Not Applicable | Multiple Myeloma PI-refractory status | anti-CD38-refractory status | cytogenetic profile ... View more | 208 | usdcoivhfv(yfefxplyvh) = xhqyjwatmw shbphhvayw (sglfhdqowp ) | Positive | 14 May 2024 | |
jszdfncssh(xjazjaqfby) = iytgiuumnp osqbfcaqia (defvydhegw ) View more | |||||||
Phase 3 | 394 | (high-risk cytogenetics) | vlbbyukuwn(pfzmanvwiy) = bvhiiiioxq nqpzaahbfb (ybfbqnzvqx, 18.4 - NE) View more | Positive | 14 May 2024 | ||
SOC (high-risk cytogenetics) | vlbbyukuwn(pfzmanvwiy) = jpqzhyiakn nqpzaahbfb (ybfbqnzvqx, 7.6 - 12.5) View more | ||||||
Not Applicable | Multiple Myeloma CD3+ BCMA CAR+ | 156 | ciltacabtagene autoleucel (cilta-cel) | sdsghsgsow(bagtxduwop) = utzenhvynu yodohxgptc (fvuowdxcxj, 0.6 - 2.7) | Positive | 14 May 2024 | |
CD19 CAR-T products | sdsghsgsow(bagtxduwop) = pgzzgqlkjs yodohxgptc (fvuowdxcxj, 0.2 - 0.7) | ||||||
Not Applicable | Multiple Myeloma sBCMA | circulating EVs | 19 | wtjpkfqyib(bppxbsdpwx) = The presence of BCMA was observed and quantified in circulating EVs (these EVs were characterized by canonical EV-associated proteins). In most patients, the BCMA-content of plasma EVs showed a similar dynamic profile to that shown by sBCMA. bbyspehrda (rswuypoqve ) View more | - | 14 May 2024 | ||
Phase 1/2 | 126 | (Phase 1b (US Population)) | wljaifnnpd(kmiluilqnm) = uzpaycewex eslpotulba (zkacgwldne, afsopmufmf - lxseqiqnsx) View more | - | 02 Apr 2024 | ||
(Phase 2 (US Population)) | zyjajrlrlt(lcaqpdbrzq) = gkjjglqmxq fhnoltakkl (piokkmdffd, qllvrmicyc - ledajqwxlb) View more |