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The US FDA Grants Accelerated Approval to Iovance’s Amtagvi (lifileucel) as a Treatment for Metastatic Melanoma (MM)

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The US FDA Grants Accelerated Approval to Iovance’s Amtagvi (lifileucel) as a Treatment for Metastatic Melanoma (MM)

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  • 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

Related News:- Iovance Biotherapeutics Reports the First Patient Randomizing of Lifileucel in P-III Trial (TILVANCE-301) for Frontline Advanced Melanoma

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Shivani Chandra

Shivani was a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She was covering news related to Product approvals, clinical trial results, and updates. We can be contacted at connect@pharmashots.com.

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