Iovance Biotherapeutics Reports the US FDA Acceptance of BLA for Lifileucel to Treat Advanced Melanoma
Shots:
- The US FDA has accepted the BLA for lifileucel to treat patients with advanced melanoma & granted Priority Review with an expected PDUFA on Nov 2023. The submission was based on the (C-144-01) trial who progressed on or after prior anti-PD-1/L1 therapy and targeted therapy
- The results showed ORR (31.4%) with 9 CRs and 39 PRs, the median time to best response was 1.5mos. and responses deepened over time, m-DOR (not reached) at 36.5mos. median study follow-up, 41.7% of responses lasted for ≥24mos. (47.8% in cohort 2; 36.0% in cohort 4), the long-term benefit was also reported
- Lifileucel, a TIL therapy received an RMAT designation from the US FDA for advanced melanoma
Ref: GlobeNewswire | Image: Iovance
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