FDA approves AbbVie’s new chronic lymphocytic leukemia treatment

SILVER SPRING, Md. — The Food and Drug Administration on Monday approved a new treatment from AbbVie for chronic lymphocytic leukemia (CLL). The drug, Venclexta (venetoclax) is the first drug to gain FDA approval that targets a protein that supports cancer cell growth and is overexpressed in many CLL patients, about 15,000 of whom are diagnosed every 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 drug is indicated for daily use following detection of 17p deletion — an abnormality in which patients lack a part of a chromosome that suppresses cancer growth that presents in 10% of untreated CLL patients and 20% of those with relapsed CLL. Venclexta received priority review, accelerated approval and the breakthrough therapy designation from the FDA.