FDA Approves Venetoclax (VENCLEXTA) For Chronic Lymphocytic Leukemia or Small Lymphocytic Leukemia
On June 8, 2018, the U.S. Food and Drug Administration (FDA) approved the use of venetoclax (VENCLEXTA) for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy. All approved venetoclax regimens begin with a 5-week ramp-up.
This approval is based on data from a clinical trial evaluating venetoclax in combination with rituximab (Rituxan). The trial compared venetoclax plus rituximab with bendamustine plus rituximab in CLL patients who had received at least one prior line of therapy. Patients in the venetoclax arm completed a five-week ramp-up schedule before receiving 400 mg of venetoclax once daily for 24 months. Rituximab, which was administered after the ramp-up schedule, was given for six 28-day cycles (375 mg/m2 intravenously on cycle one day one and 500 mg/m2 intravenously on day one of cycles two through six).
Read more about this approval on lymphoma.org/cllfdaupdates or on the FDA's website. You can also read the Lymphoma Research Foundation's (LRF) official statement.
For additional information on this approval, contact the LRF Helpline at (800) 500-9976 or helpline@lymphoma.org. LRF's trained Helpline staff is available to provide you with tailored information on chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), its treatment options, clinical trials, resources for the disease, and answer your specific questions about this approval.
LRF is committed to providing those impacted by lymphoma and CLL with the resources they need to better understand their disease and make the most informed decisions about their treatment and long term care. The Foundation has developed a series of educational resources specifically for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), including:
Website:
Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma Lymphoma Learning Center
Free Publications:
Chronic Lymphocytic Leukemia Comprehensive Guide
Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma Fact Sheet
Videos and Webcasts:
Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma Video
Bruce D. Cheson, MD, FACP, FAAS
Chronic Lymphocytic Leukemia/ Small Lymphocytic Webcast
Neil Kay, MD
Mobile App:
Focus On Lymphoma Mobile App
Featuring a medication reminder tool to help with adherence to oral therapy schedule.
Educational Programs:
North American Educational Forum on Lymphoma
Featuring CLL/SLL specific sessions with leading expert, Steven Rosen, MD (City of Hope)
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