FDA Approves New Treatment Option for Previously Treated Chronic Lymphocytic Leukemia
June 8th, 2018
On June 8, 2018, the FDA approved Venclexta® (venetoclax) in combination with Rituxan® (rituximab) for the treatment of people with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL), with or without 17p deletion, who have received at least one prior therapy.
News in brief
- The approval is primarily based on results from the Phase III MURANO study, which compared Venclexta plus Rituxan against a current standard of care in previously treated CLL.
- CLL is the most common type of adult leukemia. CLL is considered incurable, and although signs of CLL may disappear for a while after initial treatment, many people require additional treatment due to the return of cancerous cells. SLL is a disease similar to CLL, but primarily occurs in the lymph nodes.
- The FDA has also converted Venclexta’s accelerated approval to a full approval. Venclexta was previously granted accelerated approval in April 2016 as a single agent for the treatment of people with CLL with 17p deletion.
Supporting Information
“We are pleased that this approval makes Venclexta, a first-of-its-kind targeted therapy, available for more people with chronic lymphocytic leukemia whose disease has returned after previous treatment. Venclexta plus Rituxan provides a new chemotherapy-free option shown to help people live longer without their disease progressing compared to a standard-of-care therapy.”