FDA Grants Chronic Lymphocytic Leukemia Drug Priority Review

Article

Venetoclax is a B-cell lymphoma-2 protein inhibitor for the treatment of CLL patients who received a least one prior therapy.

The FDA granted priority review for a drug to be used on adults with chronic lymphocytic leukemia (CLL).

Venetoclax is an inhibitor of B-cell lymphoma-2 (BCL-2) protein for the treatment of CLL patients who received a least one prior therapy, including those with 17p deletion. Researchers believe that venetoclax can induce apoptosis.

In April 2015, the FDA granted venetoclax Breakthrough Therapy Designation for previously treated CLL patients with the 17p deletion genetic mutation. Venetoclax selectively inhibits the function of the BCL-2 protein, which can be overexpressed in some types of cancer.

"The FDA acceptance and EMA (European Medicines Agency) validation of AbbVie's Venetoclax submissions mark a major step forward as we work to become a global leader in oncology, providing new therapies for patients with cancer," said Executive Vice President of Research and Development at AbbVie, Michael Severino, MD, in a press release. "Patients are always our number one priority and we accelerated our efforts to bring venetoclax, the first BCL-2 inhibitor, to patients with CLL in need of new therapies, including those with 17p deletion who typically have a poor prognosis."

The New Drug Application and Marketing Authorization Application were supported by data from a phase 2 study of patients with relapsed CLL with 17p deletion. According to AbbVie, the study met its primary endpoint of achieving an overall response rate.

Venetoclax is currently under evaluation in phase 3 clinical trials for relapsed/refractory CLL, in addition to being studied in several other types of cancer.

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