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Novartis CAR-T Therapy's Swift Approval Aided By REMS And New US FDA Review Model

 
• By Brenda Sandburg

Risk Evaluation and Mitigation Strategy for Kymriah requires the acute lymphoblastic leukemia treatment be administered by certified centers, while a postmarketing study will assess safety over 15 years. FDA's early approval reflects efforts by the biologics center and new cross-cutting Oncology Center for Excellence to implement a more collaborative review model.

Decorin protein

FDA's swift approval of Novartis AG's chimeric antigen receptor T-cell therapy Kymriah (tisagenlecleucel) was aided by the company's Risk Evaluation and Mitigation Strategy (REMS), which requires hospitals dispensing the treatment to be certified.

FDA approved Kymriah, the first gene therapy to clear the agency, on Aug. 30 for the treatment of patients up...

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More from Approvals

US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
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The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.

Autolus’s Aucatzyl And GSK’s Blenrep Among 10 New Drugs To Get EMA Nod

 
• By Vibha Sharma

The European Medicines Agency has OKd 10 new medicines for EU-wide approval, including a CAR-T therapy for treating acute lymphoblastic leukemia. Two drugs were, however, rejected.

EU Authorization Before US? Biologics Manufacturing Is Likely To Blame

 
• By Bridget Silverman

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New EU Approvals

 
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US FDA Meeting Drought Ends … With A Vengeance

 
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EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.