Pharma Focus Asia

WuXi Advanced Therapies Receives FDA Approval for Manufacturing Iovance's AMTAGVI™ (lifileucel) for Advanced Melanoma

Thursday, February 22, 2024

WuXi Advanced Therapies (WuXi ATU), a subsidiary of WuXi AppTec, has received approval from the U.S. Food and Drug Administration (FDA) to initiate analytical testing and manufacturing of AMTAGVI for Iovance. This approval follows the FDA's accelerated approval of Iovance's Biologics License Application (BLA) on February 16, 2024.

AMTAGVI is a personalized T cell immunotherapy designed for adult patients with advanced melanoma who have previously received specific treatments. It marks a significant advancement as the first one-time, personalized T cell therapy approved for solid tumor cancer in the United States.

With this milestone, WuXi ATU's Philadelphia site becomes the first external manufacturing site in the U.S. and the first third-party contract testing, development, and manufacturing organization (CTDMO) approved by the FDA for commercial production of an individualized T cell therapy for solid tumors.

WuXi ATU and Vice Chairman of WuXi AppTec, congratulated Iovance on achieving this milestone and expressed pride in their partnership since 2015. He emphasized WuXi ATU's commitment to supporting healthcare innovators and delivering groundbreaking treatments to patients worldwide.

Iovance, headquartered in San Carlos, California, operates the Iovance Cell Therapy Center (iCTC) adjacent to WuXi ATU in the Navy Yard Philadelphia. The company focuses on developing tumor-infiltrating lymphocyte (TIL) cell therapies, including gene-edited cell therapies, for cancer patients.

Iovance, highlighted the significance of AMTAGVI's accelerated approval in addressing the unmet needs of patients with advanced melanoma. He praised the partnership with WuXi ATU, spanning close to a decade, and emphasized the collaborative advantage of having a contract testing, development, and manufacturing partner adjacent to their facilities.



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