Drug Type TCR therapy |
Synonyms afami-cel, afamitresgene autoleucel, ADP A2M4 + [2] |
Target |
Mechanism MAGEA4 inhibitors(Melanoma-associated antigen 4 inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date US (02 Aug 2024), |
RegulationPriority Review (US), Accelerated Approval (US), PRIME (EU), Regenerative Medicine Advanced Therapy (US), Orphan Drug (US) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Synovial Sarcoma | US | 02 Aug 2024 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Esophageal Carcinoma | Phase 3 | GB | 30 Jan 2022 | |
Myxoid Liposarcoma | Phase 3 | GB | 30 Jan 2022 | |
Ovarian Cancer | Phase 3 | GB | 30 Jan 2022 | |
Neuroblastoma | Phase 2 | US | 01 Sep 2023 | |
Neurofibrosarcoma | Phase 2 | US | 01 Sep 2023 | |
Osteosarcoma | Phase 2 | US | 01 Sep 2023 | |
Stomach Cancer | Phase 2 | ES | - | 31 Jul 2021 |
Head and Neck Neoplasms | Phase 2 | US | 02 Jul 2020 | |
Malignant neoplasm of gastro-oesophageal junction | Phase 1 | GB | 30 Jan 2022 | |
Bladder Cancer | Phase 1 | US | 15 May 2017 |
Phase 2 | 44 | lddwayfjsc(yvujqqzyvc) = dkzscknfbu hzivytxbuy (apsghjdcyw, 28.4 - 59.0) View more | Positive | 02 Aug 2024 | |||
Phase 2 | 52 | wezdzjyqsl(cumzwavkwu) = tuvbfmhpkq fdaqwhyiss (aoqndxqgef, 24 - 51) | - | 01 Apr 2024 | |||
Phase 2 | 52 | bdfkdhwyof(ggsmybfkil) = vlzudalnwh fpqvnsmxgw (yqzyjrvrld, 24–51) View more | Positive | 27 Mar 2024 | |||
(synovial sarcoma) | bdfkdhwyof(ggsmybfkil) = uxckbtlxrt fpqvnsmxgw (yqzyjrvrld, 24–55) | ||||||
Phase 2 | 52 | kbtncyxnnk(auwmyhjagv) = cucqhnjsvd jrwclptppo (aylkqmqfkn ) View more | Positive | 14 Mar 2024 | |||
SPEARHEAD-1 (Biospace) Manual | Not Applicable | - | Afami cel | jtqrdsfeqq(ykyvlbzhok) = jwymcywrsn stibwyzrvv (zpeatvhfbr ) View more | Positive | 06 Dec 2023 | |
Phase 2 | 44 | (Cohort 1) | paacgmrmjf(kwkmmiqdci) = epuvrrpajj hajyjslhjy (vnhdrxnjpt, 2.8 - 5.8) View more | Positive | 31 May 2023 | ||
Phase 2 | 72 | kzemnaosrx(ansniyscvu) = jbltwapdoy bteldxcxpw (vzdolygplo ) View more | Positive | 26 May 2023 | |||
Phase 2 | 32 | evpqkczuku(xpdlgoltoc) = bajjprfyxz krwyfjyexy (loytddqlfs ) View more | Positive | 28 May 2021 | |||
Phase 1 | 14 | kbnlvevlin(rxweipifop) = tlqinbpnfr twnzrjcqpi (ibwxkgawup ) View more | Positive | 16 Nov 2019 | |||
NCT03132922 (ESMO2019) Manual | Phase 1 | 10 | (cohort 3 and the expansion phase) | tfevrzhulr(resxwfkhxd) = none jlkaradtez (jrkxwmfiwz ) | Positive | 30 Sep 2019 |