By Mary de Wet
Iovance Biotherapeutics shares rose 15% in after-hours trade Friday after the company’s biologics license application for lifileucel to treat advanced skin cancer was approved by the Food and Drug Administration.
The stock was at $8.67 after closing at $7.55 in regular trade. Shares are up 18% for the year.
“The FDA is not currently planning to hold an advisory committee meeting to discuss this application and, after a preliminary review, has not at this time identified any potential review issues,” the San Carlos, Calif.-based company said.
Lifileucel is a tumor infiltrating lymphocyte therapy intended for patients with advanced melanoma who progressed on or after prior anti-PD-1/L1 therapy and targeted therapy, Iovance said.
There are no FDA-approved therapies to treat these patients, the company said.
With the biologics license application approved, Iovance can get a license to market lifileucel in the U.S.
Write to Mary de Wet at [email protected]
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