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    Roche Venclexta/Venclyxto combination shows promising results in phase III VIALE-A study in Leukemia patients

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2020-03-29T12:15:02+05:30  |  Updated On 29 March 2020 12:15 PM IST
    Roche Venclexta/Venclyxto combination shows promising results in phase III VIALE-A study in Leukemia patients

    Venclexta/Venclyxto is being developed by AbbVie and Roche.

    Basel: Roche has announced that the phase III VIALE-A study met its dual primary endpoints of overall survival and composite complete remission rate (CR + CRi). Venclexta®/Venclyxto® (venetoclax) in combination with azacitidine, a hypomethylating agent, showed a statistically significant improvement in overall survival in people with previously untreated acute myeloid leukaemia (AML) who were ineligible for intensive induction chemotherapy, compared to azacitidine alone. Safety for Venclexta/Venclyxto plus azacitidine appeared consistent with the known safety profile of these medicines.

    "Acute myeloid leukemia remains a challenging blood cancer, with particularly low median survival rates in patients who cannot tolerate intensive chemotherapy given their age or underlying health," said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. "These data validate the benefit that this Venclexta/Venclyxto-based combination can bring to patients and we look forward to discussing the results with health authorities."

    Data from the VIALE-A study will be shared with global health authorities and presented at an upcoming medical meeting. Venclexta has previously been granted accelerated approval by the US Food and Drug Administration (FDA) in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of people with newly-diagnosed AML who are aged 75 years or older, or for those ineligible for intensive induction chemotherapy due to coexisting medical conditions, based on response rates from the M14-358 and M14-387 studies. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory studies. Venclexta has also been granted five Breakthrough Therapy Designations by the FDA, including two for previously untreated AML.

    Venclexta/Venclyxto is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the US, and commercialized by AbbVie outside of the US.

    Read also: Roche begins Phase III clinical trial of Actemra in hospitalised patients with severe COVID-19 pneumonia

    rochevenclextaazacitidinemyeloid-leukaemialevi-garraway

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    Medical Dialogues Bureau
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      Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers.  Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in. Check out more about our bureau/team here

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