FDA approves Venclexta for tough-to-treat type of leukemia

Venclexta is being developed by AbbVie and Genentech. It is the first therapy approved by the FDA, targeting the the B-cell lymphoma 2 (BCL-2) protein which supports cancer cell growth and often is overexpressed in CLL.

The FDA’s approval was based on the results of a single-arm trial of 106 patients with CLL and 17p deletion who had received at least one prior therapy.

Patients received doses of venetoclax that increased from 20 mg to 400 mg over a 5-week period.

In total, 80% of the patients achieved a complete or partial remission of their cancer.

The most common adverse events associated with venetoclax include neutropenia, diarrhea, nausea, anemia, upper respiratory tract infection, thrombocytopenia and fatigue.

Severe adverse events can include pneumonia, neutropenia with fever, fever, autoimmune hemolytic anemia, anemia and tumor lysis syndrome.

Venetoclax earlier secured breakthrough therapy designation, priority review status, accelerated approval and orphan drug designation for this indication.

AbbVie executive vice president of research and development and chief scientific officer Michael Severino said: "The approval of Venclexta as a first-in-class BCL-2 inhibitor gives physicians an important option for the treatment of relapsed/refractory CLL harboring the 17p deletion.

"With the efficacy observed in this patient population, Venclexta has the potential to be an important and new therapy, advancing our efforts to bring novel treatment options to patients with this type of cancer."

Image: AbbVie US Headquarters. Photo: courtesy of AbbVie Inc.