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

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 ā‰„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.

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