WuXi ATU gains approval for Amtagvi manufacturing at US site
21 Feb 2024
ImmunotherapyCell TherapyDrug ApprovalGene TherapyClinical Study
Preview
Source: Pharmaceutical Technology
WuXi Advanced Therapies’ 55,000ft² commercial non-viral cell therapy manufacturing site in Philadelphia, US. Credit: WuXi AppTec.
Preview
Source: Pharmaceutical Technology
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.
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 inhibitormitogen-activated protein kinase inhibitor.
See Also:Telehealth abortion is an “effective, safe” tool for equitable healthcare – US study
Preview
Source: Pharmaceutical Technology
Apilimod mesylate by OrphAI Therapeutics for Amyotrophic Lateral Sclerosis: Likelihood of Approval
Preview
Source: Pharmaceutical Technology
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.
It is the first contract testing, development and manufacturing organisation to receive such an endorsement.
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.
“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.
Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.
Free WhitepaperCell and gene therapies: Pipe dream to pipeline
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.
Preview
Source: Pharmaceutical Technology
-->
By downloading this case study, you acknowledge that GlobalData may share your information with Cytiva Thematic and that your personal data will be used as described in their Privacy Policy
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Indications
Hot reports
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.