FDA give accelerated approval to Roche’s Venclexta

Roche has announced that the FDA has granted accelerated approval to Venclexta, in combination with a hypomethylating agent (azacitidine or decitabine), or low-dose cytarabine, for the treatment of patients 75 years or older, with newly-diagnosed acute myeloid leukaemia, or for those ineligible for intensive induction chemotherapy due to coexisting medical conditions. The approval was based on the M14-358 and M14-387 studies which showed durable remissions in these patients. At least 5% of patients in the studies experienced some serious side effects such as fatigue, device-related infection, pneumonia, bacteria in the blood, low white blood cell count with fever, inflammation of tissue under the skin, multiple organ dysfunction syndrome, diarrhoea, bleeding, localized infection, and respiratory failure.

Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development, said: “Today’s approval marks a significant advance for people with acute myeloid leukaemia, a highly aggressive and difficult-to-treat blood cancer. Many people with acute myeloid leukaemia are unable to tolerate standard intensive chemotherapy, and the Venclexta combination regimens represent important new options for these patients.”