Afamitresgene autoleucel
| Clinical data | |
|---|---|
| Trade names | Tecelra |
| Other names | MAGE-A4C1032T |
| License data | |
| Routes of administration | Intravenous infusion |
| ATC code |
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| Legal status | |
| Legal status | |
| Identifiers | |
| UNII | |
Afamitresgene autoleucel, sold under the brand name Tecelra is a T cell immunotherapy used for the treatment of synovial sarcoma.[1][2]
The most common adverse reactions include cytokine release syndrome, nausea, vomiting, fatigue, infections, pyrexia, constipation, dyspnea, abdominal pain, non-cardiac chest pain, decreased appetite, tachycardia, back pain, hypotension, diarrhea, and edema.[3]
Afamitresgene autoleucel was approved for medical use in the United States in August 2024.[2][3][4]
Medical uses
[edit]Afamitresgene autoleucel is a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices.[1][3]
Adverse effects
[edit]The US Food and Drug Administration (FDA) prescribing information includes a boxed warning for serious or fatal cytokine release syndrome, which may be severe or life-threatening.[3]
The most common adverse reactions include cytokine release syndrome, nausea, vomiting, fatigue, infections, pyrexia, constipation, dyspnea, abdominal pain, non-cardiac chest pain, decreased appetite, tachycardia, back pain, hypotension, diarrhea, and edema.[3] The most common grade 3 or 4 laboratory abnormalities include lymphocyte count decreased, neutrophil count decreased, white cell blood count decreased, red blood cell decreased, and platelet count decreased.[3]
History
[edit]Efficacy was evaluated in SPEARHEAD-1, cohort 1, a multicenter, single-arm, open-label clinical trial that enrolled HLA-A*02:01-03 and 06 allele positive participants with inoperable or metastatic synovial sarcoma who had received prior systemic therapy with either doxorubicin and/or ifosfamide and whose tumor expressed the MAGE-A4 tumor antigen.[3] Participants received lymphodepleting chemotherapy with fludarabine and cyclophosphamide.[3] Fifty-two participants with synovial sarcoma were enrolled and underwent leukapheresis, eight of whom did not receive afamitresgene autoleucel due to death (n=3), loss of eligibility prior to lymphodepleting chemotherapy (n=3), withdrawal by patient (n=1), and investigator decision (n=1).[3] Forty-five participants received lymphodepletion and one patient withdrew consent before treatment, for a total of 44 participants who received a single infusion of afamitresgene autoleucel.[3]
Society and culture
[edit]Legal status
[edit]Afamitresgene autoleucel was approved for medical use in the United States under the accelerated approval pathway in August 2024.[2][3] The FDA granted the application for famitresgene autoleucel regenerative medicine advanced therapy, priority review, and orphan drug designations.[3]
Names
[edit]Afamitresgene autoleucel is the international nonproprietary name.[5]
References
[edit]- ^ a b c "Tecelra (afamitresgene autoleucel) suspension, for intravenous infusion". U.S. Food and Drug Administration (FDA). Archived from the original on 5 August 2024. Retrieved 5 August 2024.
- ^ a b c d "Tecelra (afamitresgene autoleucel)". U.S. Food and Drug Administration. 1 August 2024. Archived from the original on 5 August 2024. Retrieved 5 August 2024.
- ^ a b c d e f g h i j k l "FDA grants accelerated approval to afamitresgene autoleucel for unresectable or metastatic synovial sarcoma". U.S. Food and Drug Administration (FDA). 2 August 2024. Archived from the original on 4 August 2024. Retrieved 5 August 2024.
This article incorporates text from this source, which is in the public domain.
- ^ "Adaptimmune Receives U.S. FDA Accelerated Approval of Tecelra (afamitresgene autoleucel), the First Approved Engineered Cell Therapy for a Solid Tumor" (Press release). Adaptimmune. 2 August 2024. Archived from the original on 4 August 2024. Retrieved 5 August 2024 – via Business Wire.
- ^ World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 84". WHO Drug Information. 34 (3). hdl:10665/340680.
Further reading
[edit]- D'Angelo SP, Araujo DM, Abdul Razak AR, Agulnik M, Attia S, Blay JY, et al. (April 2024). "Afamitresgene autoleucel for advanced synovial sarcoma and myxoid round cell liposarcoma (SPEARHEAD-1): an international, open-label, phase 2 trial". Lancet (London, England). 403 (10435): 1460–1471. doi:10.1016/S0140-6736(24)00319-2. PMID 38554725.
- Hong DS, Van Tine BA, Biswas S, McAlpine C, Johnson ML, Olszanski AJ, et al. (January 2023). "Autologous T cell therapy for MAGE-A4+ solid cancers in HLA-A*02+ patients: a phase 1 trial". Nature Medicine. 29 (1): 104–114. doi:10.1038/s41591-022-02128-z. PMC 9873554. PMID 36624315.
External links
[edit]- "Afamitresgene Autoleucel (Code C175738)". NCI Thesaurus.
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