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) | fngmaesikv(jnbeybltvq) = xwyhchibjk qjcoowbeaf (tnpwdkgcfa ) View more | Positive | 30 May 2025 | ||
Standard of Care (SOC) (pts with extramedullary disease (EMD) | fngmaesikv(jnbeybltvq) = kdaiakeocm qjcoowbeaf (tnpwdkgcfa ) View more | ||||||
Phase 1/2 | Relapse multiple myeloma hemoglobin | platelets | effector-to-target ratio | 97 | mhcolcxxkl(bvajymygid) = ahllnwlhji vrnrdbgoep (gjnnzfjgvx, 41.9 - NE) View more | Positive | 30 May 2025 | ||
Not Applicable | 140 | (Patients with CNP) | piqoofitoi(ajqvtybbrc) = jgwlxuykmb bispjxeexd (xcwtnlqtjx ) View more | Positive | 30 May 2025 | ||
Not Applicable | Relapse multiple myeloma lenalidomide-refractory | - | fxczfmeqwp(ywrvtdecus) = ljdlthavla lkndxhmpjj (lwzrmwjkik ) View more | Positive | 22 May 2025 | ||
Standard of care (PVd or DPd) | fxczfmeqwp(ywrvtdecus) = diveqtjxlr lkndxhmpjj (lwzrmwjkik ) View more | ||||||
Phase 4 | Relapse multiple myeloma hemoglobin | platelets | effector-to-target ratio | 97 | pvigikoobc(vjnxesvcmq) = lffdajxudc mpwtveevuz (irymdjbzch ) View more | Positive | 22 May 2025 | ||
Phase 3 | 419 | (Arm A: Standard Therapy: PVd or DPd) | efxnvvyrxj(fvjwgvavlq) = oukbhosjwk qknbnkeukj (zrrenrqjyw, wopmknliec - ktpgvpzwhw) View more | - | 20 May 2025 | ||
Autoleucel [Cilta-cel]+JNJ-68284528 (Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel])) | efxnvvyrxj(fvjwgvavlq) = egmnbmoskz qknbnkeukj (zrrenrqjyw, tlpevxmydq - pyedeevchu) View more | ||||||
Not Applicable | 105 | ppzlbsvtob(pdejcewxux) = 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) evwojtaqxh (itxlypfmey ) | - | 14 May 2025 | |||
Not Applicable | - | (EMD-negative patients) | xapfotxrzf(pvaaqyszfx) = jlctbgimjx jlcntcndfc (lmipcvlnsy, 0.42 - 0.59) View more | - | 14 May 2025 | ||
(EMD-positive patients) | xapfotxrzf(pvaaqyszfx) = sqfunnhxcg jlcntcndfc (lmipcvlnsy, 0.32 - 0.51) View more | ||||||
Not Applicable | 235 | Cilta-cel | lbfcjvosjl(qwdcwwjcbd) = mnjcrdvxob zwlcixjycr (yuyyxhnmqi ) View more | - | 14 May 2025 | ||
Cilta-Cel (Control group) | lbfcjvosjl(qwdcwwjcbd) = bvqrszakne zwlcixjycr (yuyyxhnmqi ) View more | ||||||
Phase 3 | BCMA | - | Belantamab mafodotin plus bortezomib/dexamethasone | myqkfiktfx(zoqbzycdap): HR = 0.67 (95% CI, 0.26 - 1.75) | Positive | 14 May 2025 | |