Novartis Leads Pipeline NewsBy
A roundup of the latest market developments from the pipelines of the pharmaceutical majors and other related news, featuring news from Novartis.
Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday April 12, 2017 to Tuesday April 18, 2017.
Novartis’ CAR-T Therapy Granted Breakthrough Therapy Status
Novartis has been granted breakthrough therapy designation by the US Food and Drug Administration (FDA) for tisagenlecleucel-T (CTL019), its investigational chimeric antigen receptor T cell (CAR-T) therapy, for treating relapsed and refractory (r/r) diffuse large B-cell lymphoma (DLBCL). This marks the second indication for which tisagenlecleucel-T has received breakthrough therapy designation from the FDA, the first being for treating r/r B-cell acute lymphoblastic leukemia (ALL).
Novartis, which is developing tisagenlecleucel-T through an August 2012 global collaboration with the University of Pennsylvania (Penn), which first developed the compound, holds the worldwide rights to CARs developed with Penn for all cancer indications. In March 2017, Novartis announced that the FDA accepted the company’s biologics license application filing and granted priority review for tisagenlecleucel-T for treating r/r B-cell ALL.