Iovance Says Amtagvi Gets Accelerated Approval for Advanced Melanoma

By Stephen Nakrosis

Iovance Biotherapeutics on Friday said the U.S. Food and Drug Administration granted an accelerated approval to Amtagvi suspension for intravenous infusion as a treatment for certain adult patients with unresectable or metastatic melanoma.

The company said Amtagvi, or lifileucel, "is the first and the only one-time, individualized T cell therapy to receive FDA approval for a solid tumor cancer." The treatment is manufactured via a proprietary process that collects and expands patient-specific T cells, called TIL cells, from a portion of the patient's tumor, the company said.

Amtagvi will be manufactured at the Iovance Cell Therapy Center in Philadelphia, the company said. The facility has capacity for up to several thousand patients annually, including a nearby contract manufacturer, and additional expansion is underway, "which will significantly increase this capacity over the next few years," Iovance said.

Trade in the company's stock was halted earlier Friday, pending news.

Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

(END) Dow Jones Newswires

February 16, 2024 15:54 ET (20:54 GMT)

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