- Iovance Biotherapeutics ( NASDAQ: IOVA ) on Thursday said it had submitted a rolling biologics license application (BLA) to the U.S. FDA for its cancer therapy lifileucel for the treatment of advanced melanoma, the most serious type of skin cancer.
- IOVA said it expects to complete the BLA submission in Q4 .
- The rolling nature of the submission will allow the company to submit parts of the BLA to the FDA on an ongoing basis, enabling the regulator to begin review as early as possible while documents are received, IOVA said.
- The exact indication for the rolling BLA submission was 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.
- The company said there were no FDA approved therapies in this treatment setting. The submission was supported by clinical data from the C-144-01 clinical trial in patients with advanced melanoma.
- IOVA stock +1% to $11.76 in premarket trading.
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Iovance submits rolling license application to FDA for skin cancer treatment lifileucel