The companies said Venclexta extended overall survival in untreated acute myeloid leukemia patients when combined with Bristol-Myers Squibb's Vidaza. A prior Phase III confirmatory trial, combining the drug with low-dose cytarabine, failed.
AbbVie said Tuesday that the FDA had placed a partial clinical hold on all Venclexta studies in myeloma due to a higher rate of deaths in the Phase III BELLINI study.
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The drug, combined with Celgene's Vidaza, Otsuka's Dacogen or low-dose cytarabine, showed strong response rates in elderly and unfit AML patients, historically a hard-to-treat population.