Wuxi ATU Gets FDA Nod for Amtagvi Production in Advanced Melanoma

WuXi Advanced Therapies (WuXi ATU), a subsidiary of WuXi AppTec, announced that its Philadelphia site has received FDA approval to begin analytical testing and manufacturing of Amtagvi for Iovance.This approval comes after Iovance received FDA-accelerated approval of its Biologics License Application (BLA) on February 16, 2024.

Amtagvi is a type of tumor-derived autologous T-cell immunotherapy that is used to treat adult patients with unresectable or metastatic melanoma.  It is used mainly for patients who have previously received treatment with a PD-1 blocking antibody and, if BRAF mutation is positive, a BRAF inhibitor with or without an MEK inhibitor. 

Amtagvi is the first and only one-time, individualized T-cell therapy to receive FDA approval for solid tumor cancer. With this announcement, WuXi ATU’s Philadelphia site becomes the first external manufacturing site in the US and the first third-party contract testing, development, and manufacturing organization (CTDMO) to receive FDA approval to support the commercial manufacturing and release of an individualized T-cell therapy for a solid tumor cancer. 

“We congratulate Iovance on this major milestone in their quest to address unmet patient needs in treating 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, the 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, headquartered in San Carlos, California, has an FDA-approved built-to-suit custom manufacturing facility, the Iovance Cell Therapy Center (CTC), adjacent to WuXi ATU in the Navy Yard Philadelphia. The company is dedicated to innovating, developing, and delivering tumor-infiltrating lymphocyte (TIL) cell therapies, including gene-edited cell therapies, for patients with cancer.