WuXi Advanced Therapies (WuXi ATU) has received approval from the US Food and Drug Administration (FDA) to begin the analytical examination and production of Iovance’s Amtagvi (lifileucel) at its facility in Philadelphia, US.
WuXi ATU is WuXi AppTec‘s wholly owned subsidiary.
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The move marks a significant milestone as Amtagvi is the first individualised T-cell therapy approved by the US regulator for adults with unresectable or metastatic melanoma.
The tumour-derived autologous T-cell immunotherapy received accelerated approval for its biologics licence application from the FDA.
It is intended for patients who received treatment with a programmed cell death 1-hindering antibody and in cases where the BRAF V600 mutation is positive and has a BRAF inhibitor with or without a mitogen-activated protein kinase inhibitor.
Amtagvi utilises the T-cells of the patient extracted from tumour tissue and manufactured for re-infusion as a single dose.
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By GlobalDataWuXi ATU’s site in Philadelphia became the first US external manufacturing location authorised to support the commercial production and supply of an individualised T-cell therapy for solid tumours.
It is the first contract testing, development and manufacturing organisation to receive such an endorsement.
Iovance operates an FDA-approved Iovance Cell Therapy Center adjacent to WuXi ATU in the Navy Yard, Philadelphia.
WuXi ATU CEO and WuXi AppTec vice-chairman Edward Hu stated: “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.”
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
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