Venetoclax was granted approval in combination with azacitidine, decitabine, or low dose cytarabine earlier this month for adults 75 years or older with newly diagnosed acute myeloid leukemia or those who have comorbidities precluding intensive induction chemotherapy.
Earlier this month, the FDA granted regular approval to venetoclax (Venclexta) in combination with azacitidine (Vidaza), decitabine, or low dose cytarabine (LDAC) for adults 75 years or older with newly diagnosed acute myeloid leukemia (AML) or those who have comorbidities precluding intensive induction chemotherapy.
The FDA initially granted accelerated approval to venetoclax for this indication in November 2018. The efficacy of venetoclax was therefore confirmed in 2 randomized, double-blind, placebo-controlled trials in the aforementioned patient population, including in the VIALE-A (NCT02993523) study and the VIALE-C study (NCT03069352).
This review was conducted under Project Orbis, where the FDA collaborated with the Australian Therapeutic Goods Administration, the Brazilian Health Regulatory Agency, Health Canada, and Switzerland’s Swissmedic.
Further, using the real-time oncology review (RTOR) pilot program, and the assessment aid, the application for the venetoclax combination was approved 5 weeks ahead of the FDA PDUFA date.
In an interview with CancerNetwork®, Courtney DiNardo, MD, MSCE, associate professor in the department of Leukemia at The University of Texas MD Anderson Cancer Center in Houston, discussed this recent approval and what it means for patients with AML.
This segment comes from the CancerNetwork® portion of the MJH Life Sciences Medical World News, airing daily on all MJH Life Sciences channels.
FDA grants regular approval to venetoclax in combination for untreated acute myeloid leukemia [news release]. FDA. Published October 16, 2020. Accessed October 29, 2020. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-regular-approval-venetoclax-combination-untreated-acute-myeloid-leukemia