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Iovance Biotherapeutics Reports Second Quarter and First Half 2023 Financial Results and Corporate Updates
FDA Priority Review of Biologics License Application (BLA) on Track for Lifileucel in Advanced Melanoma with Prescription Drug User Fee Act (PDUFA) Action
About this update from Iovance Biotherapeutics, Inc.
[{"type":"text","content":"FDA Priority Review of Biologics License Application (BLA) on Track for Lifileucel in Advanced Melanoma with Prescription Drug User Fee Act (PDUFA) Action Date of November 25, 2023 Preparing for Potential Commercial Launch of Lifileucel as First Approved TIL Therapy in 2023 Post-Anti-PD-1 Non-Small Cell Lung Cancer TIL Program Advances into Registrational Development SAN CARLOS, Calif., Aug. 08, 2023 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today reported second quarter and first half 2023 financial results and corporate updates. Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, “Iovance is making significant progress in executing on our goals. The Priority Review of our BLA for lifileucel in advanced melanoma remains on track and continues to progress well as we work collaboratively with FDA and approach a potential approval and launch this year. We acquired Proleukin®, which will provide revenue, streamline our supply chain and logistics, reduce our future cost of goods and lower expenses for IL-2 used with TIL therapies. We are also excited about our NSCLC pipeline, with a registrational trial and positive preliminary data in post-anti-PD-1 patients and the upcoming full data presentation for TIL therapy in combination with pembrolizumab in ICI naïve patients. We are well positioned to execute on our regulatory, pipeline, manufacturing and commercial launch activities to advance our mission to be the global leader in TIL therapy.” Recent and Second Quarter 2023 Highlights and Corporate Updates Iovance TIL Therapy (Lifileucel) in Advanced MelanomaRegulatory Highlights The U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) for lifileucel for patients with advanced melanoma. The FDA granted lifileucel Priority Review and assigned November 25, 2023, as the target action date for a decision under the Prescription Drug User Fee Act (PDUFA).The first patient was randomized in the registrational Phase 3 global TILVANCE-301 trial to support accelerated and full approvals of lifileucel in combination with pembrolizumab in frontline advanced melanoma. TILVANCE-301, which ...