Novartis personalized cell therapy CTL019 receives FDA Breakthrough Therapy designation

Designation supports the advancement of CTL019 to help address the unmet need of patients with relapsed/refractory acute lymphoblastic leukemia (r/r ALL). The filing was submitted by the University of Pennsylvania's Perelman School of Medicine which is conducting the CTL019 Phase I/II clinical trials - Novartis and Penn have exclusive global collaboration to research, develop and commercialize CAR'T cell therapies for the investigational treatment of cancers Basel, July 7, 2014 - Novartis announced today that the United States Food and Drug Administration (FDA) 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 (r/r ALL). The Breakthrough Therapy filing was submitted by the University of Pennsylvania's Perelman School of Medicine (Penn) 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, continuing the company's trajectory as a leader in developing innovative therapies to help treat diseases in which there remains significant unmet medical need , , , . Novartis' Zykadia^(TM) (ceritinib, previously known as LDK378), for the treatment of anaplastic lymphoma kinase positive (ALK+) metastatic non-small cell lung cancer (NSCLC), is one of the first medicines to receive an FDA approval following earlier receipt of Breakthrough Therapy designation by the FDA.