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FDA grants breakthrough therapy designation to CTL019 for DLBCL
The FDA granted breakthrough therapy designation to CTL019 for the treatment of adults with relapsed and refractory diffuse large B-cell lymphoma who failed two or more prior therapies, according to the drug’s manufacturer.
CTL019 (Novartis) is an investigational chimeric antigen receptor T-cell therapy.
“At Novartis, we are eager to unlock the full potential of CTL019, including the potential to help patients with relapsed and refractory DLBCL,” Vas Narasimhan, global head of drug development and chief medical officer of Novartis, said in a company-issued press release. “We look forward to working closely with the FDA to help bring this potential new treatment option to patients as soon as possible.”
The FDA based the designation on data from the multicenter phase 2 JULIET study, designed to evaluate the safety and efficacy of CTL019 in adults with relapsed and refractory DLBCL.
Findings are expected to be presented at an upcoming medical congress, according to the press release.
The FDA previously granted priority review to CTL019 for the treatment of pediatric and young adult patients with relapsed and refractory B-cell acute lymphoblastic leukemia.
“We are encouraged by the FDA’s recognition in the potential of CTL019 for this indication, which follows our promising studies of this therapy for ALL and the FDA filing by Novartis in pediatric and young adult ALL that received priority review,” Carl June, MD, director of the Center for Cellular Immunotherapies at Perelman School of Medicine at University of Pennsylvania, said in the release. “Work with our collaborators at trial sites across the world is paving a path to bring personalized cell therapies to more patients with these devastating blood cancers.”