AbbVie Inc. — Venclexta FDA Review (NDA208573, SUPPL 20, 2020)

Report summary

The FDA approved AbbVie's VENCLEXTA (venetoclax) on October 16, 2020, for newly diagnosed acute myeloid leukemia (AML) in adults 75 or older, or those with comorbidities precluding intensive chemotherapy. This approval converts a previous accelerated approval to full approval, based on efficacy and safety data from pivotal Phase 3 trials (VIALE-A, VIALE-C) and long-term follow-up studies. VENCLEXTA, in combination with azacitidine, decitabine, or low-dose cytarabine (LDAC), demonstrated improved overall survival, complete remission rates, and transfusion independence compared to placebo or monotherapy. While VIALE-A showed significant overall survival benefit with venetoclax plus azacitidine, VIALE-C's primary overall survival endpoint for venetoclax plus LDAC was not statistically significant in the initial analysis, though subsequent follow-up showed improvement. Common adverse reactions include neutropenia, infections, and tumor lysis syndrome. The safety profile is consistent with known drug effects and AML's natural history, with no increased early mortality. Pharmacokinetic analyses support the dosing regimens, and no dose adjustments are needed for renal impairment. The review also addressed labeling and postmarketing requirements.

Key findings — cited to the page