The FDA has approved venetoclax (Venclexta) as a treatment for certain patients with chronic lymphocytic leukemia.
The FDA has approved venetoclax (Venclexta) as a treatment for certain patients with chronic lymphocytic leukemia (CLL).
Venclexta is designed for patients who have a chromosomal abnormality called 17p deletion and who have already been treated with at least 1 prior therapy.
It is now the first FDA-approved treatment that targets the B-cell lymphoma 2 protein.
“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, in a press release. “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 FDA’s approval was based on a clinical trial involving 106 CLL patients with a 17p deletion.
The patients took Venclexta once daily orally with doses starting at 20 mg and ending at 400 mg over a 5-week period.
Around 80% of the patients had complete or partial remission of their cancer by the end of the study period.
The most common adverse effects associated with Venclexta are diarrhea, nausea, low red blood cell count, and upper respiratory tract infection. It may also cause fertility problems in males.
Other serious complications including pneumonia, neutropenia with fever, fever, autoimmune hemolytic anemia, anemia, and metabolic abnormalities are also possible.
Pharmacists should be aware that patients taking Venclextta should not receive live attenuated vaccines.