Venetoclax 10mg tablets

BackgroundIn younger, fit patients with acute myeloid leukemia (AML), intensive chemotherapy (IC) followed by consolidation or allogeneic hematopoietic stem cell transplantation (HSCT) is the standard approach. The authors performed a systematic review and meta-analysis to evaluate younger patients with AML treated with hypomethylating agents (HMA) plus venetoclax.MethodsThis systematic review and meta-analysis was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. MEDLINE and the Cochrane Library were systematically searched through February 2026. Studies included AML patients with a median age ResultsEight studies (two randomized controlled trials, two phase 2 trials, and four real-world studies), comprising 429 patients with a mean age of 54 years, were included. The pooled CR/CRi rate was 66% (95% confidence interval [CI], 48%-85%), with an MRD-negative rate of 69% (95% CI, 49%-90%). The pooled 1-year OS was 75% (95% CI, 63%-86%), exceeding Surveillance, Epidemiology, and End Results database cohorts (62%). The 1-year EFS was 59% (95% CI, 53%-65%), with low between-study heterogeneity. Overall, 66% of patients successfully proceeded to HSCT. Meta-regression analyses suggested a trend toward improved EFS and OS in studies using decitabine than azacitidine.ConclusionsIn younger patients with AML, HMA plus venetoclax yielded high response rates, MRD negativity, and a substantial proportion of patients proceeding to HSCT. These findings support HMA/venetoclax as an effective induction strategy in selected younger patients and provide a rationale for prospective randomized trials comparing this approach with IC-based regimens.

Abstract licence: CC BY

AbstractThis systematic review summarizes the evidence informing 2 recommendations from the updated American Society of Hematology guidelines for the treatment of newly diagnosed acute myeloid leukemia in older adults, comparing conventional induction and postremission therapy vs hypomethylating agents (HMA)- or low-dose cytarabine (LDAC)-based strategies, with or without venetoclax. We searched Ovid MEDLINE and Embase, and Cochrane CENTRAL through February 2024, and monitored these databases for new studies throughout November 2024. We included randomized controlled trials (RCTs) and nonrandomized studies (NRS). Reviewers screened studies, extracted data, assessed risk of bias, conducted random-effects meta-analyses, and rated certainty of evidence using GRADE (grading of recommendations, assessment, development, and evaluation). We included 21 studies (3 RCTs, 18 NRS). Compared with HMA- or LDAC-based monotherapy, conventional 7+3-type remission induction therapy may reduce mortality at longest follow-up (risk ratio [RR], 0.94; 95% confidence interval [CI], 0.85-1.04; low certainty), increase complete remission rates (odds ratio, 1.75; 95% CI, 1.25-2.38; high certainty), and may reduce recurrence at longest follow-up (RR, 0.81; 95% CI, 0.64-1.04; low certainty). Conventional therapies probably increase most severe toxicities (moderate certainty). Compared with HMA or LDAC combined with venetoclax, very low certainty evidence suggests that conventional therapy may reduce 1-year mortality (RR, 0.72; 95% CI, 0.60-0.87), increase allogeneic transplant rates (RR, 2.28; 95% CI, 1.70-3.06), result in no important differences in complete remission or recurrence, and have variable effects on severe toxicities. Conventional therapy may have benefits over HMA or LDAC alone; however, compared with HMA or LDAC plus venetoclax, the evidence remains of very low certainty.

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