Medication Monitor

Generic Name (Trade Name—Company)
June 12, 2019


(Venclexta—AbbVie, Genentech)
FDA approves venetoclax for CLL and SLL

FDA approved venetoclax for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Approval was based on CLL14, a randomized (1:1), multicenter, open-label, actively controlled trial of venetoclax in combination with obinutuzumab (VEN+G) versus obinutuzumab in combination with chlorambucil (GClb) in 432 patients with previously untreated CLL with coexisting medical conditions.

The trial demonstrated a statistically significant improvement in progression-free survival (PFS) for patients who received VEN+G compared with those who received GClb. The overall response rate was 85% in the VEN+G arm compared with 71% in the GClb arm.

The trial also demonstrated statistically significant improvements in rates of minimal residual disease negativity (< 1 CLL cell per 104 leukocytes) in bone marrow and peripheral blood. Overall survival data were not mature at this analysis.

In CLL/SLL, the most common adverse reactions (≥20%) for venetoclax when administered with obinutuzumab, rituximab, or as monotherapy were neutropenia, thrombocytopenia, anemia, diarrhea, nausea, upper respiratory tract infection, cough, musculoskeletal pain, fatigue, and edema.

View full prescribing information for recommended starting and ramp-up dosages.