WuXi Advanced Therapies (WuXi ATU) has secured approval from the US Food and Drug Administration (FDA) to manufacture Iovance Biotherapeutics’ Amtagvi (lifileucel) for advanced melanoma at its Philadelphia site in Pennsylvania, US.

The contract testing, development, and manufacturing organisation (CTDMO) is a wholly owned subsidiary of WuXi AppTec. It will now begin the analytical testing and manufacturing at its 55,000ft² commercial non-viral cell therapy manufacturing site.

Amtagvi is a tumour-derived autologous T cell immunotherapy.

It is indicated to treat adults having unresectable or metastatic melanoma. The approval is for its use in patients treated with a PD-1 blocking antibody in the past and, if the tumour has a BRAF V600 mutation, a BRAF inhibitor with or without a MEK inhibitor.

Amtagvi is the first and only one-time, customised T cell therapy to be approved by the FDA for solid tumour malignancy.

Last week, Iovance secured FDA accelerated approval of its biologics license application (BLA) for Amtagvi.

WuXi ATU CEO and WuXi AppTec vice chairman Edward Hu said: “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.

“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 location will now support the commercial manufacturing and release of this individualised T cell therapy for solid tumour cancer.

Iovance interim CEO and president Frederick Vogt said: “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.”