Don Tracy, Associate Editor

Amtagvi is the first one-time, individualized T-cell therapy approved by the FDA for any solid tumor cancer.

WuXi Advanced Therapies announced that it has officially received approval from the FDA to begin analytical testing and manufacturing of Amtagvi (lifileucel), Iovance Biotherapeutics’ recently approved treatment for advanced melanoma. According to a company press release, the treatment is a tumor-derived autologous T cell immunotherapy, specifically developed for adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody. This also marks the first one-time, individualized T cell therapy to be approved by the FDA for any solid tumor 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, CEO, WuXi ATU, Vice Chairman, WuXi AppTec, in the press release. "We are proud of our track record of enabling healthcare innovators to advance medical discoveries and deliver groundbreaking treatments to patients globally."

WuXi ATU’s Philadelphia manufacturing site will now begin work as the first US external manufacturing site and the first third-party contract testing, development, and manufacturing organization (CTDMO) approved by the FDA to support the commercial manufacturing of an individualized T-cell therapy for solid tumor 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, PhD, JD, interim CEO, president, Iovance, in the release. "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."

As previously alluded to, the FDA approved Amtagvi earlier this week for adults with unresectable or metastatic melanoma who received prior treatment with a PD-1 antibody, and in patients who are BRAF V600-positive who received prior treatment a BRAF inhibitor with or without a MEK inhibitor. Amtagvi was approved through the agency’s Accelerated Approval pathway, which allows the FDA to give the go ahead for drugs that treat serious or life-threatening illnesses or conditions for which there is an unmet medical need. Furthermore, the drug is required to show effective clinical benefit to patients.

“Melanoma is a life-threatening cancer that can cause devastating impacts to affected individuals, with a significant risk of metastasizing and spreading to other areas in the body,” said Nicole Verdun, MD, director, Office of Therapeutic Products in CBER. “Today’s approval reflects the FDA’s dedication and commitment to the development of innovative, safe and effective treatment options for cancer patients.”