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CHMP recommends extended approval of Venclyxto for acute myeloid leukemia.- AbbVie

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Published:26th Apr 2021

AbbVie announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Venclyxto (venetoclax) in combination with hypomethylating agents for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. The positive CHMP opinion represents the third for an extension of indications for Venclyxto. The opinion is based on results from the double-blind, placebo-controlled VIALE-A (M15-656) and the Phase Ib open-label, nonrandomized, multicenter M14-358 trial.

Condition: Acute Myelogeous Leukemia (AML)

Type: drug

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