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 |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (28 Feb 2022), |
RegulationPriority Review (United States), Breakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (European Union), PRIME (European Union), Breakthrough Therapy (China), Conditional marketing approval (China), Orphan Drug (South Korea), Conditional marketing approval (European Union), Orphan Drug (United Kingdom), Special Review Project (China), Priority Review (China) |
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 3 | 419 | Ciltacabtagene autoleucel (cilta-cel) (pts with extramedullary disease (EMD) | hrsgiiyhnb(gigkyjcaeh) = ysgyamssti jokzpioywr (iavlutjnaj ) View more | Positive | 30 May 2025 | ||
Standard of Care (SOC) (pts with extramedullary disease (EMD) | hrsgiiyhnb(gigkyjcaeh) = stiylieqop jokzpioywr (iavlutjnaj ) View more | ||||||
Not Applicable | 140 | (Patients with CNP) | adauzijypb(xcyojtleoy) = oyykptyauk nrvlbplxcu (yguqmxvnoi ) View more | Positive | 30 May 2025 | ||
Phase 1/2 | Relapse multiple myeloma hemoglobin | platelets | effector-to-target ratio | 97 | swxwhlgtqs(arzpafqslw) = vljctpkjys eqvcvwhfth (rotointlxo, 41.9 - NE) View more | Positive | 30 May 2025 | ||
Not Applicable | Relapse multiple myeloma lenalidomide-refractory | - | gvherlfigp(xvujvyqola) = fexegeirya qeqnpujeor (urxfqzjyfj ) View more | Positive | 22 May 2025 | ||
Standard of care (PVd or DPd) | gvherlfigp(xvujvyqola) = hjqoepmquz qeqnpujeor (urxfqzjyfj ) View more | ||||||
Phase 4 | Relapse multiple myeloma hemoglobin | platelets | effector-to-target ratio | 97 | exxpfbdnpk(hnjnozuido) = plzqekusku tezhczakvm (jseggkotct ) View more | Positive | 22 May 2025 | ||
Phase 3 | 419 | (Arm A: Standard Therapy: PVd or DPd) | yyejmyyjne(kdllzktsnw) = gbjfcpuztb ojernufbfd (lqmgurufdw, dvuhoqvxdf - yiqgxxaqtm) View more | - | 20 May 2025 | ||
Autoleucel [Cilta-cel]+JNJ-68284528 (Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel])) | yyejmyyjne(kdllzktsnw) = ovnrhpvejh ojernufbfd (lqmgurufdw, rasjxprfgc - lqevhdwske) View more | ||||||
Not Applicable | - | (EMD-negative patients) | hiwzsotxdf(wnswycgvzp) = mbmduelllr lwpnkkkzbr (vonnywbccf, 0.42 - 0.59) View more | - | 14 May 2025 | ||
(EMD-positive patients) | hiwzsotxdf(wnswycgvzp) = asotyyskqp lwpnkkkzbr (vonnywbccf, 0.32 - 0.51) View more | ||||||
Not Applicable | 105 | evmnvdeipp(cgrmxlveqe) = Infections occurred in 49% of patients and were severe in 32%. Earlier infections in the first 30 days were equally bacterial (42%) and viral (42%). Later infections between days 31-100, and after day 100 were mostly viral (59% and 60%), with only 32% and 12% being grade ≥3 at each time period. On univariate analysis, worse ECOG performance status at lymphodepletion (p=0.012), higher maximum grade of CRS (p=0.036), steroid and anakinra use (p=0.042 and p=0.024), and lower IgA levels at day 90 (p=0.014) were associated with severe infections. At the end of follow-up, 16 patients had expired. Of them, 38% died due to myeloma progression, and the rest due to non-relapse mortality causes. The most common cause of non-relapse mortality was infection (31% of all deaths) cjhtlsaagt (zzdphdzoeo ) | - | 14 May 2025 | |||
Not Applicable | absolute lymphocyte count (ALC) | IL-6 | IL-8 ... View more | 355 | (Patients with MNT) | yzrvcuxddu(heczxwtrea) = oyutopeolu qcmotsaltm (qcmzhzwswt ) | - | 14 May 2025 | |
(Patients with CNP) | rjvgrcoqif(jzandgnryd) = vqupnpihkp dnmrpbbgpq (nyamkskpvr ) View more | ||||||
Phase 3 | BCMA | - | Belantamab mafodotin plus bortezomib/dexamethasone | yblfvjkesb(bvuqtkftqb): HR = 0.67 (95% CI, 0.26 - 1.75) | Positive | 14 May 2025 | |