FDA Decision Looms for Iovance's Lifileucel as a Potential Melanoma Breakthrough Treatment
• Iovance Biotherapeutics is developing a new cancer treatment, lifileucel, using tumor-infiltrating lymphocytes. It's under FDA review to treat melanoma.
• In a trial, lifileucel shrank tumors for half of advanced mucosal melanoma patients who had worsened despite other treatments. 4 of 6 responders were still responding at 24 months.
• The FDA decision on approving lifileucel for melanoma is expected by February 24, 2024. Iovance is also testing it in cervical cancer.
• Wall Street analysts think lifileucel could lead to Iovance being acquired. Its market cap is $1.6 billion but it has no revenue yet and lost $328 million in the first 9 months of 2023.
• The stock could fall hard if the FDA delays approval again. It's high-risk but analysts see 219% upside by 2024.