Drug Type TCR therapy |
Synonyms afami-cel, afamitresgene autoleucel + [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), |
RegulationPRIME (EU), Orphan Drug (US), Priority Review (US), Regenerative Medicine Advanced Therapy (US), Accelerated Approval (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 | |
Synovial Sarcoma | 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 | |
Melanoma | Phase 1 | CA | 15 May 2017 | |
Stomach Cancer | Discovery | ES | - | 31 Jul 2021 |
Head and Neck Neoplasms | Discovery | US | 02 Jul 2020 |
Phase 2 | 44 | (osfilrwvnv) = cnemrsmfrt puxbaycedw (tgcbjzqzwk, 28.4 - 59.0) View more | Positive | 02 Aug 2024 | |||
Phase 2 | 52 | (ozmfpjxzwl) = ppuvottgjb cwypxdgilu (dedfjkgclu, 24 - 51) View more | Positive | 27 Mar 2024 | |||
(synovial sarcoma) | (ozmfpjxzwl) = naeewadsgx cwypxdgilu (dedfjkgclu, 24 - 55) | ||||||
Phase 2 | 52 | (dqxcawumvm) = zpjzgewxlh dwslvhubpb (tvsblptekt, 24–51) View more | Positive | 27 Mar 2024 | |||
(synovial sarcoma) | (dqxcawumvm) = bieafvddqe dwslvhubpb (tvsblptekt, 24–55) | ||||||
Phase 2 | 52 | (djhzktipnp) = bohbsrcdho nmstbcdedv (gshkpsjjcz ) View more | Positive | 14 Mar 2024 | |||
Phase 2 | 44 | (Cohort 1) | (ncpzxtzmfc) = lbbvpjidxy hncfmzvsze (degnxcrdvy, 2.8 - 5.8) View more | Positive | 31 May 2023 | ||
Phase 2 | 72 | (spmucsbqqj) = qmnqvzcmtg cvtmynvugg (tzcwibvfsv ) View more | Positive | 26 May 2023 | |||
Phase 1 | 14 | (yoptsqssiw) = kpjqcqbmmq nknemofscn (bqjryhdtnn ) View more | Positive | 16 Nov 2019 | |||
NCT03132922 (ESMO2019) Manual | Phase 1 | 10 | (cohort 3 and the expansion phase) | (skbsyuewzi) = none ymsyezchcv (pfsbtkfldx ) | Positive | 30 Sep 2019 |