Venclexta Indicated for CLL or SLL, Alone or in Combination with Rituxan

August 2018, Vol 8, No 8 - FDA Approvals, News & Updates


On June 8, 2018, the FDA approved venetoclax (Venclexta; AbbVie/Genentech) for patients with chronic lymphocytic leukemia (CLL) or with small lymphocytic lymphoma (SLL), regardless of 17p deletion, who received previous therapy, as monotherapy or in combination with rituximab (Rituxan; Genentech).

The new indication for venetoclax plus rituximab was based on MURANO, a multicenter, open-label clinical trial of 389 patients with CLL who received ≥1 previous therapies. Patients received venetoclax plus rituximab or bendamustine plus rituximab. Patients in the venetoclax arm received venetoclax 400 mg once daily for 2 years after completing a 5-week ramp-up of venetoclax. Rituximab was added on day 1 of each of the 6 cycles of 28-day length. Patients in the bendamustine plus rituximab arm received the combination for 6 cycles of 28-day length (bendamustine on days 1-2 of each cycle, and rituximab on day 1 of each cycle).

At 23 months, the median progression-free survival was not reached in the venetoclax arm and was 18.1 months in the bendamustine arm (P <.0001). The overall response rate was 92% in the venetoclax plus rituximab arm versus 72% in the bendamustine plus rituximab arm.

Grade 3 or 4 neutropenia was 64% in the venetoclax plus rituximab arm; grade 4 neutropenia was 31%. Serious adverse events (46%) and serious infections (21%) were also reported. The most common (9%) serious infection was pneumonia. Tumor lysis syndrome is a significant risk associated with venetoclax.