Home Hematology and Oncology FDA Approves Venclexta for CLL With 17p Deletion

FDA Approves Venclexta for CLL With 17p Deletion

Drug sanctioned for chronic lymphocytic leukemia in patients with a specific chromosomal abnormality

MONDAY, April 11, 2016 (HealthDay News) — Venclexta (venetoclax) has been approved by the U.S. Food and Drug Administration to treat chronic lymphocytic leukemia (CLL) characterized by a specific chromosomal abnormality, 17p deletion, in patients who have been treated with at least one prior therapy.

The newly approved drug targets the B-cell lymphoma 2 protein, which promotes cancer growth and often is overabundant in patients with CLL, the FDA said. Venclexta’s effectiveness was tested in clinical studies involving 106 patients with CLL who have a 17p deletion and who had received at least one prior therapy. Eighty percent of trial participants showed a complete or partial remission, the agency said.

The drug’s most common side effects included neutropenia, diarrhea, nausea, anemia, upper respiratory infection, thrombocytopenia, and fatigue. More serious complications included pneumonia, fever, and more severe anemia. Patients who take Venclexta should not be given live attenuated vaccines.

Venclexta is indicated for daily use following confirmation of 17p deletion via the FDA-approved companion diagnostic Vysis CLL FISH probe kit.

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

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