Adaptimmune’s Tecelra Gains the US FDA’s Accelerated Approval to Treat Synovial Sarcoma
Shots:
- The US FDA has granted accelerated approval to Tecelra (afamitresgene autoleucel) for treating unresectable or metastatic synovial sarcoma adults previously treated with CT, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P +ve & their tumors express MAGE-A4. Full approval depends upon the confirmatory study
- Approval was supported by data of cohort 1 from the P-II (SPEARHEAD-1) study assessing the safety & efficacy of Tecelra in adults (n=44) with metastatic or inoperable synovial sarcoma (cohorts 1, 2 & 3) or MRCLS (cohort 1)
- The study showed an ORR of 43%, CRR of 4.5% & mDoR of 6mos.; DoR was 12mos. or longer among 39% of the responders. Data was published in The Lancet earlier in 2024
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
