Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has granted accelerated approval to Venclexta® (venetoclax), in combination with a hypomethylating agent (azacitidine or decitabine), or low dose cytarabine (LDAC), for the treatment of people with newly-diagnosed acute myeloid leukaemia (AML), who are age 75 years or older, or for those ineligible for intensive induction chemotherapy due to coexisting medical conditions. AML is the most common type of aggressive leukaemia in adults and has the lowest survival rate for all types of leukaemia.
“Today’s approval marks a significant advance for people with acute myeloid leukaemia, a highly aggressive and difficult-to-treat blood cancer,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “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.”
This accelerated approval was based on results from the M14-358 study and the M14-387 study in people newly-diagnosed with AML including those who were ineligible for intensive induction chemotherapy. In M14-358, the rate of complete remission (CR) was 37% (n=25/67) and the rate of complete remission with partial blood count recovery (CRh) was 24% (n=16/67) for those who received Venclexta plus azacitidine. For those who received Venclexta plus decitabine, the rate of CR was 54% (n=7/13) and the rate of CRh was 8% (n=1/13). M14-387 showed a CR rate of 21% (n=13/61) and a CRh rate of 21% (n=13/61) for those who received Venclexta in combination with LDAC.
The most common serious side effects of these regimens (occurring in at least 5% of patients) were low white blood cell count with fever, pneumonia, bacteria in the blood, inflammation of tissue under the skin, device-related infection, diarrhoea, fatigue, bleeding, localized infection, multiple organ dysfunction syndrome, and respiratory failure.