Clinical trial results published in the journal Nature Medicine show 91 percent response rate to the combination of venetoclax with azacitidine in older adults newly diagnosed with acute myeloid leukemia (AML). Of 33 patients given combination venetoclax and azacitidine, 20 experienced a complete response (aka complete remission) and eight experienced a complete response but with continued low blood counts. Of the three patients who did not respond to treatment, two discontinued the study before the first week due to personal reasons unrelated to treatment or side-effects.
Based on these results, on November 21, the U.S. Food and Drug Administration (USFDA) granted accelerated approval for venetoclax to treat patients who are aged 75 years and older or are ineligible for intensive chemotherapy due to coexisting medical conditions. Updated clinical trial results and scientific findings will be presented December 1-4 at the 60th annual American Society of Hematology (ASH) meeting in San Diego, CA.
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