Novartis announced that the company has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for CTL019 (tisagenlecleucel) for two indications. The application is for the treatment of children and young adults with relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (ALL) and for adult patients with r/r diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant (ASCT). CTL019 is a novel immunocellular therapy and a one-time treatment that uses a patient’s own T cells to fight cancer.
“Since the historic FDA approval of Kymriah, formerly CTL019, we have launched, manufactured and supplied this highly individualized immunocelluar therapy in a commercial setting and the submission to the EMA is a major step toward our goal of delivering it to more critically ill cancer patients around the world,” said Vas Narasimhan, Global Head of Drug Development and Chief Medical Officer, Novartis. “We look forward to working with the EMA to make CTL019 available to the children and adults who may benefit from this novel therapy.”
There has been a dire need for innovative therapies to treat pediatric and young adult patients with r/r B-cell ALL and adult patients with r/r DLBCL, who have few options and historically poor outcomes. DLBCL is the most common subtype of non-Hodgkin lymphoma (NHL), accounting for 40% of all NHL cases globally[1]. If left untreated, r/r DLBCL has a life expectancy of three to four months[2]. In Europe, ALL accounts for approximately 80% of leukemia cases among children[3]. Less than 10% of patients with relapsed or refractory ALL survive five years[4].
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