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Iovance gets FDA accelerated approval for advanced melanoma therapy (NASDAQ:IOVA)
Iovance Biotherapeutics (NASDAQ:IOVA) has received FDA accelerated approval for its T-cell immunotherapy lifileucel, also known as Amtagvi, in the treatment of advanced melanoma.
The biotech company said in a statement that Amtagvi was the first and only one-time, individualized T-cell therapy to receive FDA approval for the treatment of a solid tumor cancer.
The product will be manufactured in Philadelphia at the Iovance Cell Therapy Center.
In September, Iovance said the FDA was extending the goal date for its decision to Feb. 24 due to resource constraints.
Shares of Iovance were halted at 2:35 p.m. ET on Friday ahead of the news.
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