IOVA - AMTAGVI Receives Accelerated FDA Approval for Advanced Melanoma

2024-02-16 15:52:13 ET

DENVER, Colo., Feb 16, 2024 (www.247marketnews.com)- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA ) announced, a few minutes ago, that the U.S. Food and Drug Administration approved its AMTAGVI (lifileucel) suspension for intravenous infusion. AMTAGVI is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody and this indication is approved under an accelerated approval based on overall response rate (ORR) and duration of response. Iovance is also conducting TILVANCE-301, a Phase 3 trial to confirm clinical benefit.

“The accelerated approval of AMTAGVI™ is the first step in realizing Iovance’s ambition to usher in the next generation of cell therapy by bringing this breakthrough to patients with advanced solid tumors,” said Frederick Vogt, Ph.D., J.D., Interim Chief Executive Officer and President of Iovance. “Given the significant unmet needs in the advanced melanoma community, we are proud to offer a personalized, one-time therapeutic option for these patients. We are continuing our development efforts to address additional unmet medical needs in patients with solid tumor cancers, making our novel cell therapies available to more patients with melanoma and other types of cancers.”

IOVA is trading at $9.6056, down $0.2644 (-2.68%), on trading volume of 3,203,136 shares.

Its 52-week range is $3.21 to $10.31 and this news could help it set a new 52-week high.

“The approval of AMTAGVI™ offers hope to those with advanced melanoma who have progressed following initial standard of care therapies, as the current treatment options are not effective for many patients,” said Samantha R. Guild, J.D., President, AIM at Melanoma Foundation. “This one-time cell therapy represents a promising innovation for the melanoma community, and we are excited by its potential to transform care for patients who are in dire need of additional therapeutic options.”

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