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July 30, 2024OTHER ANNOUNCEMENTS AND ARTICLES
August 2, 2024August 01, 2024 - Adaptimmune Therapeutics plc announced U.S. Food and Drug Administration (FDA) accelerated approval of Tecelra (afamitresgene autoleucel) for
- the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy,
- who 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.
This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
- Tecelra is the first engineered cell therapy for a solid tumor cancer approved in the U.S.
- It is the first new therapy option in more than a decade for synovial sarcoma, a rare, soft tissue cancer that most commonly impacts young adults.
- Tecelra uses each patient’s own immune cells to recognize and attack their cancer cells in a one-time infusion treatment and is significantly different than the current standards of care for advanced synovial sarcoma.
Source: Adaptimmune Therapeutics plc