Advisory committee to review Novartis’ CAR T therapy

FDA’s Oncologic Drugs Advisory Committee (ODAC) is to meet on July 12 to discuss a BLA from Novartis AG (NYSE:NVS; SIX:NOVN) for tisagenlecleucel-T (CTL019) to treat relapsed or refractory B cell acute lymphoblastic leukemia (ALL) in patients ages 3 to 25. The advisory committee meeting will be the first for a chimeric antigen receptor T cell therapy.

Tisagenlecleucel-T is under Priority Review from FDA, with a PDUFA date in early October. The therapy comprises autologous T cells loaded with a lentiviral vector expressing CART-19, which consists of a cancer antigen-binding domain targeting CD19 linked to CD3zeta/CD137 immunostimulatory domains. It has breakthrough therapy designation from FDA to treat acute ALL and relapsed and refractory diffuse large B cell lymphoma...