Roche announces positive CHMP opinion for Venclyxto-based combinations in certain patients with acute myeloid leukaemia
Basel, 23 April 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency ’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Venclyxto® (venetoclax) in combination with a hypomethylating agent for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy. Bas ed on this positive CHMP recommendation, a final decision regarding the approval of Venclyxto in certain patients with untreated AML is expected from the European Commission in the near future.“Today’s recommendation by the CHMP is a major step towards bringing Venclyxto combinations to patients living with this difficult-to-treat and aggressive blood cancer,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “This treatment may provide a meaningful improvement on existing options, particularly for older AML patients who typically have a poor prognosis.”The positive recommendation is based on results from the phase III VIALE-A and the phase I/II M14-358 studies of Venclyxto in people with newly diagnosed AML who are ineligible for intensive chemotherapy. Results of the VIALE-A study showed Venclyxto plus azacitidine significantly reduced the risk of death by 34% (overall survival; OS), compared to azacitidine alone (HR=0.66; 95% CI: 0.52, 0.85; p
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