AbbVie gets FDA clearance for new Venclexta indication

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AbbVie gets FDA clearance for new Venclexta indication

By Sandra Levy - 11/27/2018
AbbVie has received the Food and Drug Administration’s nod for Venclexta (venetoclax tablets) in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia, or AML, in adults age 75 years old or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

"AML is an extremely aggressive and debilitating blood cancer, and outcomes for patients ineligible for intensive chemotherapy are very poor," AbbVie executive vice president of research and development and chief scientific officer Michael Severino said."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."

Venclexta is an oral B-cell lymphoma-2 inhibitor. It is now approved for use in two different blood cancers: newly-diagnosed AML and relapsed/refractory chronic lymphocytic leukemia.

The approval in AML is the third provided under priority review by the FDA for Venclexta, which has been granted four Breakthrough Therapy Designations by the FDA.

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