An Expanded Access Study for Venetoclax in Combination With Low-Dose Cytarabine in Treatment-Naive Subjects With Acute Myeloid Leukemia Who Are Ineligible for Intensive Induction Therapy in Japan [M19-916]

Overall, venetoclax was well-tolerated in subjects with AML who were not eligible for intensive chemotherapy at Japanese sites. Venetoclax + LDAC has a favorable benefit-risk profile. The AEs are consistent with the known safety profile of venetoclax in the AML population and was successfully managed with standard medical treatment. No new safety signals were observed in the study. No subject reported TLS.