AbbVie, Roche's Venclexta approved by FDA for some patients with chronic lymphocytic leukaemia

The FDA on Monday cleared AbbVie and Roche's Venclexta (venetoclax) for the treatment of patients with chronic lymphocytic leukaemia (CLL) who carry the 17p deletion and who have been treated with at least one prior therapy. The agency noted that Venclexta is the "first FDA-approved treatment that targets the B-cell lymphoma 2 (BCL-2) protein, which supports cancer cell growth and is overexpressed in many patients with CLL."

The approval was supported by safety and efficacy data from a clinical study of 106 patients with CLL who carry the 17p deletion and who had received at least one prior therapy. In the study, the results of which were previously reported in December last year, nearly 80 percent of patients exhibited complete or partial remission of their cancer.

The FDA noted that the BCL-2 inhibitor, which analysts forecast will have peak annual sales of $1.7 billion, is indicated for daily use after p17 deletion has been confirmed using the FDA-approved companion diagnostic Vysis CLL FISH probe kit.

The agency granted priority review status to Venclexta in January for the treatment of certain patients with CLL after previously awarding the drug breakthrough therapy designation in May last year. The drug additionally received breakthrough therapy status from the FDA earlier this year for the treatment of relapsed/refractory CLL in combination with Roche's Rituxan (rituximab).

Venclexta is being developed by AbbVie and Roche's Genentech unit, and will be marketed by both companies in the US and by AbbVie outside of the US. AbbVie said it expects the drug to be commercially available in the US within a week.

To read more Top Story articles, click here.