Biologics

FDA Grants Approval to WuXi Advanced Therapies for the Manufacturing of Iovance’s AMTAGVI™ (lifileucel) for Advanced Melanoma

Published March. 26. 2024
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WuXi Advanced Therapies has secured FDA approval for the manufacturing of Iovance’s AMTAGVI™ (lifileucel), marking a significant milestone as the first and only one-time, individualised T-cell therapy to gain U.S. FDA approval for treating solid tumour cancer. AMTAGVI is specifically indicated for adult patients with unresectable or metastatic melanoma who were previously treated with a PD-1 blocking antibody, and, if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.

This development establishes WuXi ATU’s Philadelphia site as the inaugural U.S. external manufacturing site and the first third-party contract testing, development, and manufacturing organization (CTDMO) to receive FDA approval for supporting the commercial manufacturing and release of an individualized T-cell therapy for solid tumour cancer. WuXi ATU has collaborated with Iovance since 2015, contributing to their journey from research and clinical manufacturing to FDA approval.

Iovance, headquartered in San Carlos, California, operates the FDA-approved Iovance Cell Therapy Center (iCTC), a custom manufacturing facility adjacent to WuXi ATU in the Navy Yard Philadelphia. The company is dedicated to advancing tumour infiltrating lymphocyte (TIL) cell therapies, including gene-edited cell therapies, for cancer patients.

The accelerated approval of AMTAGVI™ represents a crucial step in Iovance’s mission to introduce the next generation of cell therapy for patients with advanced solid tumours. Frederick Vogt, Ph.D., J.D., Interim Chief Executive Officer and President of Iovance, emphasized the significant contribution of WuXi ATU in manufacturing this cell therapy over nearly a decade, underscoring the partnership’s positive impact on patients and the healthcare community.

 

About Iovance Biotherapeutics, Inc.

Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) aspires to lead globally in innovating, developing, and delivering tumour-infiltrating lymphocyte (TIL) cell therapies for cancer patients. Pioneering a transformative approach, Iovance aims to leverage the human immune system’s capability to identify and eliminate diverse cancer cells in each individual. The Iovance TIL platform has shown promising clinical data across various solid tumors, with AMTAGVI™ being the first FDA-approved T-cell therapy for a solid tumor indication. The commitment extends to continuous innovation in cell therapy, including gene-edited cell therapy, offering potential solutions for cancer patients.

 

About WuXi Advanced Therapies (WuXi ATU)

WuXi Advanced Therapies (WuXi ATU), the advanced therapies business unit of WuXi AppTec, operates as a Contract Testing, Development, and Manufacturing Organization (CTDMO). WuXi ATU provides advanced platforms and comprehensive solutions that facilitate the exploration, development, testing, manufacturing, and commercialization of cell and gene therapies. Their services and solutions accelerate time to market, supporting customer programs worldwide.

 

Source: https://www.prnewswire.com/news-releases/wuxi-advanced-therapies-receives-fda-approval-to-manufacture-iovances-amtagvi-lifileucel-for-advanced-melanoma-302065790.html

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