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Home » FDA Accepts Novartis, Kite Pharma’s Personalized Cancer Treatments for Review
FDA Accepts Novartis, Kite Pharma’s Personalized Cancer Treatments for Review
April 6, 2017
The FDA has accepted for review the first two novel, personalized cancer treatments — known as chimeric antigen receptor T-cell therapies, or CAR-T — using immune system cells drawn from the blood and reprogrammed to target cancer cells.
Novartis was granted priority review for its CTL019 (tisagenlecleucel-T) treatment for younger patients with B-cell acute lymphoblastic leukemia. Also last week, Kite Pharma completed its rolling BLA for axicabtagene ciloleucel, previously known as KTE-C19, for non-Hodgkin lymphoma patients ineligible for stem cell transplants.
Novartis is basing its application in part on a global Phase II study, where 82 percent of 50 patients infused with CAR-T cells achieved complete remission or complete remission with incomplete blood count recovery after three months. Nearly half of the patients in the trial experienced grade 3 or 4 cytokine release syndrome, but there were no deaths. Novartis said it plans to submit an application with the European Medicines Agency later this year.
In December 2015, Kite’s axicabtagene received a Breakthrough Therapy designation in three types of lymphoma. If approved, Kite plans to commercially launch axicabtagene ciloleucel in 2017; an EMA application is also planned for this year.
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