Venclexta Granted Accelerated Approval by FDA for Acute Myeloid Leukemia

Officials with the FDA have granted accelerated approval to venetoclax (Venclexta) for treating newly-diagnosed acute myeloid leukemia (AML) in patients who are ineligible for intensive induction chemotherapy, according to Genentech.

The agency today also approved Pfizer’s glasdegib (Daurismo) for the treatment of AML. 

Venetoclax is indicated for use in combination with a hypomethyelating agent (azacitidine or decitabine) or low-dose cytarabine (LDAC), in patients who are aged 75 years and older or are ineligible for intensive chemotherapy due to coexisting medical conditions. With this approval, venetoclax offers a new treatment option for individuals with AML, regardless of subtypes.

Venetoclax is designed to selectively bind and inhibit the B-cell lymphoma-2 protein, a protein that builds up in some blood cancers and tumors and prevents cancer cells from dying or self-destructing, according to the press release.

The accelerated approval is based on 2 studies: M14-358 and M14-387. In both studies, treatment with venetoclax plus LDAC showed durable remission in patients with newly-diagnosed AML who were 60 years or older, or who were ineligible for intensive induction chemotherapy.

In the M14-358 study, 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 venetoclax plus azacitidine. At the time of analysis, for patients who achieved CR, the median observed time in remission was 5.5 months.

The CR rate was 54% and the CRh was 8% for patients treated with venetoclax plus decitabine. The median observed time in remission in these patients was 4.7 months.

In the M14-387 study, there was a CR rate was 21% and the CRh rate was 21% for those who received venetoclax in combination with LDAC. At the time of analysis, the median observed time in remission was 6 months.

“Today’s approval marks a significant advance for people with acute myeloid leukemia, a highly aggressive and difficult-to-treat blood cancer,” Sandra Horning, MD, chief medical officer and head of Global Product Development, said in a statement. “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.”

Venetoclax is being jointly developed by AbbVie and Genentech, a member of the Roche Group.


Genentech Announces FDA Grants Venclexta Accelerated Approval for People With Newly-Diagnosed Acute Myeloid Leukemia or Those Who Are Ineligible For Intensive Induction Chemotherapy [news releases]. Genentech’s website. Accessed November 21, 2018.

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