FDA Approves Venetoclax (VENCLEXTA) For CLL ... - CLL Support

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FDA Approves Venetoclax (VENCLEXTA) For CLL or SLL with or without 17p deletion, who have received at least one prior therapy

lankisterguy
lankisterguyVolunteer

FDA Approves Venetoclax (VENCLEXTA) For Chronic Lymphocytic Leukemia or Small Lymphocytic Leukemia

support.lymphoma.org/site/M...

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)

6 Replies

Great news for patients. Thanks for the update.

Michael

Hi Len. Thank you for this post. My oncologist tells me if I fail Imbruvica he would add Venetoclax to Imbruvica. I know there clinical trails based on the two combo but I am assuming he would give it to me off label. He never mentioned Venetoclax + Rituximab. Maybe he is not up to date on all these.

lankisterguy
lankisterguyVolunteer in reply to shazie

If your nodes are small you may not need Rituxan. I believe that Ibrutinib and Venetoclax is proving to be the best combo and adding Rituxan doesn't help much, but ask your doctor about the pros and cons

shazie
shazie in reply to lankisterguy

Thanks

Perfect timing. This is terrific. Taking the great news to my Dr next week. Thanks

Cllcanada
CllcanadaTop Poster CURE Hero

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