AbbVie’s Venclexta approved for AML in adults
SAN JUAN – The Food and Drug Administration (FDA) granted accelerated approval to venetoclax in combination with azacitidine, decitabine or low-dose cytarabine to treat newly diagnosed adults with acute myeloid leukemia (AML) who are age 75 or older.
AML is one of the most aggressive blood cancers, with a very low survival rate and few options for patients who are ineligible for intensive chemotherapy. Because many patients with AML are unable to tolerate intensive chemotherapy due to age, poor health or comorbidities, venetoclax (Venclexta; AbbVie, Genentech) provides a new treatment option.
The approval also applies to adults with AML who are ineligible for intensive chemotherapy.
Venetoclax is being studied in several other hematologic malignancies including chronic lymphocytic leukemia (CLL), multiple myeloma (MM), non-Hodgkin lymphoma (NHL) and myelodysplastic syndrome (MDS). Venetoclax is being developed by AbbVie and Roche and is jointly commercialized by AbbVie and Genentech.
“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.”
AbbVie’s Puerto Rico facilities in Barceloneta are part of several that support biologics, active pharmaceutical ingredients and drug production around the world.