BASEL (dpa-AFX) - Swiss drugmaker Novartis AG (NVS) said Monday that the United States Food and Drug Administration has granted Breakthrough Therapy status to CTL019, an investigational chimeric antigen receptor (CAR) therapy for the treatment of pediatric and adult patients with relapsed/refractory acute lymphoblastic leukemia.
The Breakthrough Therapy filing was submitted by the University of Pennsylvania's Perelman School of Medicine which has an exclusive global agreement with Novartis to research, develop and commercialize personalized CAR T cell therapies for the treatment of cancers.
This is the fifth Breakthrough Therapy designation for Novartis.
The FDA Breakthrough Therapy designation is intended to expedite the development and review of new medicines that treat serious or life-threatening conditions if the therapy has demonstrated substantial improvement over an available therapy on at least one clinically significant endpoint.
The designation includes all of the fast track program features, as well as more intensive FDA guidance. It is a distinct status from both accelerated approval and priority review, which can also be granted to the same drug if relevant criteria are met.
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