AbbVie Gets European Expanded Approval of Venclyxto

By Colin Kellaher

AbbVie Inc. on Tuesday said the European Commission approved the expanded use of its cancer drug Venclyxto in combination with a hypomethylating agent for the treatment of adults with newly diagnosed acute myeloid leukemia who are ineligible for intensive chemotherapy.

The North Chicago, Ill., biopharmaceutical company said the approval is based on a Phase 3 study in which patients who received Venclyxto in combination with the hypomethylating agent azacitidine showed statistically significantly greater median overall survival than patients receiving azacitidine alone.

AbbVie and Roche Holding AG are jointly developing Venclyxto, which is approved for indications in chronic lymphocytic leukemia and acute myeloid leukemia. The drug is jointly marketed by AbbVie and Roche's Genentech in the U.S., and by AbbVie alone outside the U.S.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

May 25, 2021 08:55 ET (12:55 GMT)

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