Novartis' CAR-T Therapy Faces Quality, Safety Concerns At FDA Advisory Panel

Unusual meeting agenda indicates that effectiveness of tisagenlecleucel-T in acute lymphoblastic leukemia is not a primary issue for US FDA advisory committee consideration at first-ever review of a CAR-T therapy; agency's draft questions focus on product quality considerations and measures for mitigating risk of cytokine release syndrome.

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US FDA briefing documents on Novartis AG's tisagenlecleucel-T (CTL109) suggest the first advisory committee review of a CART-T therapy will focus more on product quality considerations, safety and risk mitigation measures than on clinical efficacy.

The Oncologic Drugs Advisory Committee will meet July 12 to consider tisagenlecleucel-T (formerly CTL109) for the treatment of pediatric and young adult patients ages three to 25 years old

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EU CHMP Opinions And MAA Updates

 

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