Tags: Cancer | leukeumia | drug | approved

New Therapy Approved for Leukemia Patients

New Therapy Approved for Leukemia Patients
(Copyright DPC)

Tuesday, 19 April 2016 05:08 PM

The U.S. Food and Drug Administration has approved a new drug, Venclexta (venetoclax), for the treatment of chronic lymphocytic leukemia (CLL).

The drug is approved for patients who have a chromosomal abnormality called 17p deletion and who have been treated with at least one prior therapy. It 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.

According to the National Cancer Institute, CLL is one of the most common types of leukemia in adults, with approximately 15,000 new cases diagnosed each year.

“These patients now have a new, targeted therapy that inhibits a protein involved in keeping tumor cells alive,” said Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “For certain patients with CLL who have not had favorable outcomes with other therapies, Venclexta may provide a new option for their specific condition.”

The approval was granted after a clinical trial of 106 patients with CLL who took Venclexta orally every day. The results showed that 80 percent of the study participants experienced a complete or partial remission of their cancer.

The FDA granted the Venclexta application breakthrough therapy designation, priority review status, and accelerated approval for this indication.

Venclexta is manufactured by AbbVie Inc. of North Chicago, Illinois, and marketed by AbbVie and Genentech USA Inc. of South San Francisco, California. The Vysis CLL FISH probe kit is manufactured by Abbott Molecular of Des Plaines, Illinois.

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The FDA has approved a new drug, Venclexta, for the treatment of chronic lymphocytic leukemia (CLL).
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2016-08-19
Tuesday, 19 April 2016 05:08 PM
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