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FDA Extends Review for Lifileucel to Treat Melanoma
The date has been extended by three months to Feb. 24, 2024, because of resource constraints at the regulatory agency.
The FDA has extended the Prescription Drug User Fee Act (PDUFA) date for Iovance Biotherapeutics’ lifileucel to treat patients with advanced melanoma from Nov. 25, 2023, to Feb. 24, 2024. Agency officials said they need more time because of resource constraints.
The review of the biologics license application continues under priority review. The FDA indicated there are no major review issues, and there are no plans to hold an advisory committee meeting. In addition, all preapproval inspections of clinical sites, manufacturing and testing facilities have been completed.
Frederick Vogt, Ph.D.
“We are confident in the potential for lifileucel to redefine the treatment paradigm for these patients,” Frederick Vogt, Ph.D., J.D., interim president and CEO of Iovance, said in a press release. “With the strength of our clinical data, manufacturing capabilities, and commercial readiness efforts, Iovance is well positioned to rapidly serve the U.S. melanoma community immediately following an approval.”
Melanoma is a type of skin cancer involving the uncontrolled growth of pigment-producing cells. It is one of the most aggressive and therapy-resistant types of cancer. According to estimates from the American Cancer Society, more than 97,000 new melanomas will be diagnosed in the United States this year, with close to 8,000 deaths expected from melanoma.
Lifileucel is a tumor-infiltrating lymphocyte (TIL) therapy designed for patients with advanced melanoma who have experienced progression after previous treatment. If approved, it would be the first TIL therapy for patients with advanced melanoma and the first one-time cell therapy for a solid tumor cancer.
Lifileucel is an individualized therapy intended for patients with advanced melanoma who progressed on or after prior anti-PD-1/L1 therapy and targeted therapy. The therapy requires a patient’s cancer-fighting cells to be collected so they can be used to manufacture an individualized treatment.
Related: FDA Accepts BLA for Lifileucel for Difficult-to-Treat Melanoma
The regulatory application is supported by data from a phase 2 trial that enrolled 153 patients. Overall response rate was 31.4% with eight complete responses and 40 partial responses. Median overall survival was 13.9 months and progression-free survival was 4.1 months.
FDA Approves Xolremdi for Ultra Rare Immune Disorder
April 29th 2024Xolremdi is the first therapy for WHIM syndrome, which can cause recurrent lung infections and papillomavirus-related warts. It’s available in two doses: 400 mg for an annual cost of $496,400 and 300 mg for an annual cost of $372,300.
FDA Approves Pfizer’s Gene Therapy Beqvez for Hemophilia
April 26th 2024Beqvez (fidanacogene elaparvovec) is priced at $3.5 million, which is on parity with Hemgenix, the first one-time therapy to treat adults with hemophilia B. Pfizer’s warranty will refund insurers and continue to provide coverage for patients if they change insurers.
