BMS received approval for Onureg in the continuation setting of acute myeloid leukemia. The drug uses the same pharmaceutical molecule as Vidaza, a drug given via IV or subcutaneously that is used upfront, but it is not intended as a substitute for it.
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.
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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.