WuXi ATU receives US FDA approval to manufacture Iovance’s Amtagvi for advanced melanoma
WuXi Advanced Therapies (WuXi ATU), a wholly owned subsidiary of WuXi AppTec, announced that the US Food and Drug Administration (FDA) has approved its Philadelphia site to begin the analytical testing and manufacturing of Amtagvi for Iovance, which received FDA accelerated approval of its Biologics License Application (BLA) on February 16, 2024.
Amtagvi is a tumour-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. Amtagvi is also the first and only one-time, individualized T cell therapy to receive US FDA approval for a solid tumour cancer.
With this announcement, WuXi ATU’s Philadelphia site becomes the first US external manufacturing site and the first third-party contract testing, development, and manufacturing organization (CTDMO) to be approved by the FDA to support the commercial manufacturing and release of an individualized T cell therapy for a solid tumour cancer.
We congratulate Iovance on this major milestone in their quest to address unmet patient needs in the treatment of advanced melanoma. WuXi ATU has partnered with Iovance since 2015, and we are thrilled to help them through each step of the drug development pipeline – from research to clinical manufacturing to FDA approval,” said Edward Hu, chief executive officer of WuXi ATU and vice chairman of WuXi AppTec. We are proud of our track record of enabling healthcare innovators to advance medical discoveries and deliver groundbreaking treatments to patients globally.
• Iovance is headquartered in San Carlos, California with an FDA-approved built-to-suit custom manufacturing facility, the Iovance Cell Therapy Center (iCTC), adjacent to WuXi ATU in the Navy Yard Philadelphia.
• The company is committed to innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies, including gene-edited cell therapies, for patients with cancer.
• The accelerated approval of Amtagvi is the first step in realizing Iovance’s ambition to usher in the next generation of cell therapy by bringing this breakthrough to patients with advanced solid tumors,” said Frederick Vogt, Ph.D., J.D., interim chief executive officer and president of Iovance.
• Given the significant unmet needs in the advanced melanoma community, we are proud to offer a personalized, one-time therapeutic option for these patients. WuXi ATU has partnered with us to manufacture this cell therapy for close to a decade. It is a great benefit to both Iovance and the healthcare community to have a contract testing, development, and manufacturing partner adjacent to our facilities. Working together our teams can make a meaningful difference for patients.
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumour infiltrating lymphocyte (TIL) cell therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells in each patient.
As the advanced therapies business unit of WuXi AppTec, WuXi Advanced Therapies is a Contract Testing, Development and Manufacturing Organization (CTDMO) that offers advanced platforms and end-to-end solutions that enable the discovery, development, testing, manufacturing, and commercialization of cell and gene therapies.
As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable the pharmaceutical and healthcare industry around the world to advance discoveries and deliver groundbreaking treatments to patients.
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