Roche announces FDA grants Venclexta accelerated approval for people with newly-diagnosed acute myeloid leukaemia or those who are ineligible for intensive induction chemotherapy

F. Hoffmann-La Roche Ltd / Roche announces FDA grants Venclexta accelerated approval for people with newly-diagnosed acute myeloid leukaemia or those who are ineligible for intensive induction chemotherapy . Processed and transmitted by West Corporation. The issuer is solely responsible for the content of this announcement.

• Approval based on two studies that showed durable remissions in people with newly-diagnosed acute myeloid leukaemia, who are age 75 years or older, or for those ineligible for intensive induction chemotherapy

Venclexta represents a new treatment option for people with acute myeloid leukaemia regardless of subtypes

Basel, 21 November 2018 - 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.