Genentech Announces FDA Grants Venclexta Accelerated Approval

Genentech, a member of the Roche Group (SIX:RO,ROG;OTCQX:RHHBY), announced that the U.S. 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 leukemia (AML), who are age 75 years or older, or for those ineligible for intensive induction chemotherapy due to coexisting medical conditions.

As quoted in the press release:

“Today’s approval marks a significant advance for people with acute myeloid leukemia, a highly aggressive and difficult-to-treat blood cancer,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “Many people with acute myeloid leukemia 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 percent (n=25/67) and the rate of complete remission with partial blood count recovery (CRh) was 24 percent (n=16/67) for those who received Venclexta plus azacitidine. For those who received Venclexta plus decitabine, the rate of CR was 54 percent (n=7/13) and the rate of CRh was 8 percent (n=1/13). M14-387 showed a CR rate of 21 percent (n=13/61) and a CRh rate of 21 percent (n=13/61) for those who received Venclexta in combination with LDAC.

Click here to read the full press release.