Novartis CTL019 granted breakthrough therapy designation in certain diffuse large B-cell lymphoma cases
The FDA recently designated CTL019 a breakthrough therapy, approving it for treatment of adult patients with relapsed and refractory (r/r) diffuse large B-cell lymphoma (DLBCL) whose treatments with two or more prior therapies have failed, Novartis said in a release.
"At Novartis, we are eager to unlock the full potential of CTL019, including the potential to help patients with r/r DLBCL," Novartis Global Head of Drug Development and Chief Medical Officer Vas Narasimhan aid in the release. "We look forward to working closely with the FDA to help bring this potential new treatment option to patients as soon as possible."
CTL019 is an investigational chimeric antigen receptor T cell (CAR-T) first developed at the University of Pennsylvania in 2012. In March, the FDA granted CTL019 priority review for treating r/r B-cell acute lymphoblastic leukemia (ALL).
"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," Penn Center for Cellular Immunotherapies Director Carl June, who led the Penn team, 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."
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