Duvelisib approved for Relapsed and Refractory CLL after failing 2 lines of therapy
April 11, 2016 – The U.S. Food and Drug Administration approved Venclexta (venetoclax) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have a chromosomal abnormality called 17p deletion and who have been treated with at least one prior therapy. Venclexta is the first FDA-approved treatment that targets the B-cell lymphoma 2 (BCL-2) protein, which supports cancer cell growth and is overexpressed in many patients with CLL.
“These patients now have a new, targeted therapy that inhibits a protein involved in keeping tumor cells alive. For certain patients with CLL who have not had favorable outcomes with other therapies, Venclexta may provide a new option for their specific condition.” said Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
You can read more at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm495253.htm
http://www.gene.com/media/press-releases/14623/2016-04-11/genentech-announces-fda-grants-venclexta
Prescribing Information: http://www.rxabbvie.com/pdf/venclexta.pdf
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