The US FDA Grants Accelerated Approval to Iovance’s Amtagvi (lifileucel) as a Treatment for Metastatic Melanoma (MM)
Shots:
- The approval was supported by the results from the P-II (C-114-01) trial assessing the safety & efficacy of Amtagvi (IV) in MM patients (n=153) previously treated with PD-1 blocking Ab or BRAF/MEK inhibitors
- The efficacy analysis in arm 4 (n=73) demonstrated that 31.5% of patients achieved ORR with mDoR not reached at 18.6mos. follow-up & the supporting pooled data from arms 4 & 2 (n=153) revealed ORR achieved in 31.4% of patients with mDoR not reached at 21.5mos. follow-up.
- Amtagvi, a tumor-derived T-cell immunotx., is being investigated in a P-III (TILVANCE-301) confirmatory trial. Additionally, Iovance has launched IovanceCares, a patient support program for Amtagvi
Ref: Iovance | Image: Iovance
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Shivani is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
