The FDA granted accelerated approval to venetoclax in combination with azacitidine, decitabine or low-dose cytarabine to treat newly diagnosed adults with acute myeloid leukemia who are 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.
“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."