Grey Approved Stamp

EU Approves Venclyxto Combinations for Acute Myeloid Leukemia

May 26, 2021

The European Commission has authorized Roche’s and AbbVie’s Venclyxto (venetoclax) combined with the hypomethylating agents azacitidine and decitabine for treating adults with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy.

The approval was supported by a phase 3 study showing Venclyxto plus azacytidine reduced the risk of death by 34 percent vs. azacytidine alone, with median overall survival of 14.7 months for the Venclyxto cohort vs. 9.6 months in participants who received azacytidine alone. In addition, a phase 1/2 study showed Venclyxto plus decitabine achieved a robust complete response in patients.

Venclyxto works by blocking the action of B-cell lymphoma protein-2 that promotes the spread of certain blood cancers and tumors.

The drug is marketed as Venclexta in the U.S., where the FDA has approved it for use in combination with azacitidine, decitabine or low-dose cytarabine for newly diagnosed AML in adults age 75 years or older who have comorbidities that rule out intensive chemotherapy.

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