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WuXi ATU gains approval for Amtagvi manufacturing at US site
21 Feb 2024
ImmunotherapyCell TherapyDrug ApprovalGene TherapyClinical Study
WuXi Advanced Therapies’ 55,000ft² commercial non-viral cell therapy manufacturing site in Philadelphia, US. Credit: WuXi AppTec.
WuXi Advanced Therapies (WuXi ATU) has received approval from the US Food and Drug Administration (FDA) to begin the anWuXi AppTecamination and production of Iovance’s Amtagvi (lifileucel) at its facility in Philadelphia, US.
WuXi ATU is WuXi AppTec‘s wholly owned subsidiary.
WuXi Advanced TherapiesicWuXi ATUstone as Amtagvi is the first indiviFood and Drug Administration (FDA)y the US regulator for adults with unresectable or metaIovancemelanoma.
WuXi ATUur-dWuXi AppTeclogous T-cell immunotherapy received accelerated approval for its biologics licence application from the FDA.
It is intended for patients who received tAmtagvit with a programmed cell death 1-hindering antibody and in cases where the BRAF V600 mutaunresectable or metastatic melanomaibitor with or without a mitogen-activated protein kinase inhibitor.
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Apilimod mesylate by OrphAI Therapeutics for Amyotrophic Lateral Sclerosis: Likelihood of ApprovalBRAFmitogen-activated protein kinase inhibitormitogen-activated protein kinase
Amtagvi utilises the T-cells of the patient extracted from tumour tissue and manufactured for re-infusion as a single dose.
WuXi 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.
Apilimod mesylateontrOrphAI TherapeuticspmentAmyotrophic Lateral Sclerosison to receive such an endorsement.
Iovance operates an FDA-approved Iovance Cell Therapy Center adjacent to WuXi ATU in the Navy Yard, Philadelphia.
WuXi ATUU 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 manuT-celling to FDA apsolid tumours
“We are proud of our track record of enabling healthcare innovators to advance medical discoveries and deliver groundbreaking treatments to patients globally.”
WuXi ATUl contentWuXi AppTecdently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.advanced melanoma
The cell and gene industry is gaining momentum, with a new wave of therapies promising to transform the way doctors treat, and even cure, disease. In this report, Cytiva and GlobalData have collaborated to explore the rise of the cell and gene therapy industries, the current state of the market, present and future opportunities for advancement, and the challenges that lie ahead.
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