The FDA granted accelerated approval to Venetoclax (Venclexta) in combination with azacitidine, decitabine or low-dose cytarabine to treat newly diagnosed patients with acute myeloid leukemia (AML) aged 75 years or older.

The approval also applies to adults with AML who are ineligible for intensive chemotherapy. Because many patients with AML are unable to tolerative intensive chemotherapy due to age, poor health or comorbidities, venetoclax (Venclexta; AbbVie, Genentech) provides a new treatment option for this population.

The approval is based on findings from the M14-358 study and the M14-387 study, 2 phase Ib/II trials in this setting. Results from the M14-358 trial showed combining venetoclax with azacitidine led to a complete remission (CR) rate of 37% and a CR with partial hematological recovery (CRh) rate of 24%, compared with 54% and 7.7%, respectively, with the combination of venetoclax and decitabine.

The M14-387 trial examined venetoclax in combination with low-dose cytarabine. The CR and CRh rates with the combination were both 21%.

“AML is an extremely aggressive and debilitating blood cancer, and outcomes for patients ineligible for intensive chemotherapy are very poor,” Michael Severino, MD, executive vice president of research and development and chief scientific officer of AbbVie, said in a press release. “This new approval for Venclexta marks a significant milestone for AbbVie and, more importantly, for patients diagnosed with this deadly disease. We look forward to continuing our work developing Venclexta and advancing treatment options in other aggressive cancers.”