First TIL Therapy BLA Submission to the U.S. Food and Drug Administration
SAN CARLOS, Calif., March 24, 2023 (GLOBE NEWSWIRE) — Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, today announced rolling Announced completion of biologics. Lifileucel License Application (BLA) submitted to the U.S. Food and Drug Administration (FDA). Lifileucel is a tumor-infiltrating lymphocyte (TIL) therapy for patients with advanced (unresectable or metastatic) melanoma that has progressed after or after anti-PD-1/L1 therapy and targeted therapy (if applicable). intended for treatment. There are no FDA-approved therapies in this therapeutic setting.
Frederick Vogt, Ph.D., JD, Interim President and Chief Executive Officer of Iovance, said: tumor. We would like to thank the patients and physicians who participated in the C-144-01 clinical trial and the FDA review team for their commitment and support. Preparations for commercialization are well underway and will support a launch later this year. We look forward to continued collaboration with the FDA as it reviews this new class of treatment for patients with advanced melanoma who have limited options. “
The BLA submission of lifileucel is supported by positive clinical trials. data From the C-144-01 clinical trial in patients with advanced melanoma after anti-PD1. Following a successful pre-BLA meeting with the FDA, Iovance is aiming for accelerated approval for this indication.Iovance arrives agreement With FDA on Phase 3 registration trial design Tilvanth-301 A trial of lifileucel in combination with pembrolizumab in frontline advanced melanoma. TILVANCE-301 is intended to support the full approval of lifileucel in advanced melanoma after anti-PD-1 and the potential for lifileucel in combination with pembrolizumab as a frontline treatment for advanced melanoma. It is also designed to support registration. Start-up activity for TILVANCE-301 is ongoing and trials are expected to progress well with the potential for early approval of lifileucel in advanced melanoma after anti-PD-1.
Dr. Marc Hurlbert, CEO of the Melanoma Research Alliance (MRA) said: We want FDA approval as soon as possible for patients with significant unmet need for whom there are no approved treatment options. “
After receiving Lifileucel’s full rolling BLA application, FDA has 60 days to determine the acceptability of the BLA for review. The rolling BLA allowed Iovance to submit portions of the BLA to the FDA on an ongoing basis, allowing the FDA to begin review as soon as possible once the documentation was received. Rolling BLA submissions and Priority Review eligibility are benefits available under the FDA. guidance Serious Condition Emergency Program to allow expedited review for 6 months from the time of BLA approval. In addition, the FDA has previously approved advanced therapies for regenerative medicine (RMATs) Refile cell designation in advanced melanoma.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics aims to be a global leader in the innovation, development and delivery of tumor-infiltrating lymphocyte (TIL) therapies for cancer patients. We are pioneering innovative approaches to treating cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells in each patient. Our lead late-stage TIL product candidate, lifileucel for metastatic melanoma, has the potential to become the first approved, one-time cell therapy for solid tumor cancers.of Iovance TIL platform show promising clinical data across multiple solid tumors. We are committed to continued innovation in cell therapies that extend and enable cancer patients to live longer, including gene-editing cell therapies. For more information, see: www.iovance.com.
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contact address
Iovance Biotherapeutics, Inc.:
Sarah Pellegrino, IRC
Senior Vice President, Investor Relations and Corporate Communications
650-260-7120 extension 264
[email protected]
jen sanders
Board of Directors, Investor Relations and Public Relations
267-485-3119
[email protected]
