Venclexta was previously granted provisional approval by FDA in late 2018.
FDA granted full approval of venetoclax (Venclexta, Genentech) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC)to treat acute myeloid leukemia (AML).
Venclexta, specifically designated to treat newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older or who have comorbidities that preclude use of intensive induction chemotherapy, was previously granted provisional approval under FDA’s accelerated approval program in late 2018.
Related: FDA clears oral leukemia drug
“Today’s full approval is supported by the significant results that showed that Venclexta in combination with azacitidine extended overall survival for people with newly diagnosed acute myeloid leukemia who cannot tolerate intensive induction chemotherapy,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development for at Genentech, in a press release.
“We are very pleased that this application was reviewed under the FDA’s Real-Time Oncology Review pilot and Project Orbis initiative, helping to bring this treatment option more rapidly to patients in the United States and other countries,” Garraway added.
The approval is primarily based on the results of two Phase 3 studies. Results of the VIALE-A study showed Venclexta plus azacitidine significantly reduced the risk of death by 34% compared to azacitidine alone (the median overall survival was 14.7 months vs. 9.6 months).
In addition, patients receiving Venclexta plus azacitidine had significantly higher rates of complete remission (CR) with 37% compared to 18% in people treated with azacitidine alone.
“Based on the results of this study, this treatment regimen represents a significant advance for older AML patients, including higher response rates, greater transfusion independence, longer durations of remission, and ultimately significantly improved overall survival compared to azacitidine alone,” said Courtney DiNardo, Md, associate professor of the Department of Leukemia, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center.
The National Comprehensive Cancer Network (NCCN) guidelines recently recommended Venclexta plus azacitidine as a Category 1 Preferred AML treatment regimen for patients ineligible for intensive chemotherapy, Genentech said.
Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the U.S. and commercialized by AbbVie outside of the country.