US regulators have issued a green light for AbbVie’s novel blood cancer drug Venclexta, approving its use in patients with chronic lymphocytic leukaemia who carry the 17p deletion chromosomal abnormality and have been treated with a least one prior therapy.
Venclexta (venetoclax) is now the first treatment approved by the US Food and Drug Administration that targets the B-cell lymphoma 2 (BCL-2) protein, which supports cancer cell growth and is over-expressed in many CLL patients.
The decision comes on the back of efficacy data from a single-arm clinical trial of 106 pre-treated CLL patients with 17p deletion, which showed that 80 percent taking the drug experienced a complete or partial remission of their cancer.
“These patients now have a new, targeted therapy that inhibits a protein involved in keeping tumour 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 favourable outcomes with other therapies, Venclexta may provide a new option for their specific condition.”
The FDA has approved its daily use after detection of 17p deletion (present in around 20 percent of patients with relapsed CLL) is confirmed through the use of the approved companion diagnostic Vysis CLL FISH probe kit.
The drug was developed in partnership with Genentech and Roche, and picked up a breakthrough designation in the US in May last year, and is also being assessed by regulators in Europe.