FDA Approves Venetoclax Combinations for Certain AML Indications

The FDA approved venetoclax (Venclexa) plus azacitadine, decitabine, or low-dose cytarabine (LDAC) for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) who are 75 years or older or have comorbidities that make them ineligible for intensive induction chemotherapy.

The FDA approved venetoclax (Venclexa) plus azacitadine, decitabine, or low dose cytarabine (LDAC) for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) who are 75 years or older or have comorbidities that make them ineligible for intensive induction chemotherapy.

The approval is based off findings from 2 double-blind, placebo-controlled trials, VIALE-A and VIALE-C.

In VIALE-A, 286 patients were randomized to receive venetoclax plus azacytidine, while 145 were randomized to receive placebo azacitadine. The venetoclax-containing regimen improved overall survival (OS) (14.7 months, compared 9.6 months in the venetoclax and placebo arms, respectively). Additionally, patients who received venetoclax had a complete remission (CR) rate of 37% compared to 18% in the placebo arm.

VIALE-C randomized 143 patients to receive venetoclax plus LDAC and 68 patients to receive placebo plus LDAC. Twenty-seven percent of patients on the venetoclax arm had a CR compared to only 7.4% on the placebo arm. The venetoclax-containing regimen also bested placebo when it came to median duration of response, with 11.1 months and 8.3 months, respectively. However, there was no significant improvement in OS with venetoclax.

Common adverse events in the venetoclax-contatining regimens included nausea, diarrhea, thrombocytopenia, constipation, neutropenia, febrile neutropenia, fatigue, vomiting, edema, pyrexia, pneumonia, dyspnea, hemorrhage, anemia, rash, abdominal pain, sepsis, musculoskeletal pain, dizziness, cough, oropharyngeal pain, and hypotension.