Iovance Biotherapeutics initiates rolling submission with FDA for Contego in advanced (unresectable or metastatic) melanoma.
Iovance Biotherapeutics announced that it has initiated a rolling Biologics License Application (BLA) submission to the FDA for Contego (lifileucel), a tumor infiltrating lymphocyte (TIL) therapy, in patients with advanced (unresectable or metastatic) melanoma who progressed on or after prior anti-PD-1/L1 therapy, and if BRAF mutation positive, also prior BRAF or BRAF/MEK inhibitor therapy. There are no FDA approved therapies in this treatment setting.
The BLA submission for lifileucel is supported by positive clinical data from the C-144-01 clinical trial in patients with advanced melanoma. Iovance plans to present additional results from the C-144-01 trial at a medical meeting later this year.
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