AbbVie and Roche's investigational BCL-2 inhibitor venetoclax was granted priority review by the FDA for the treatment of chronic lymphocytic leukaemia (CLL) in patients, including those with p17 deletion, who received at least one prior therapy, Roche announced Tuesday. Roche chief medical officer Sandra Horning said "we look forward to working with AbbVie and health authorities to bring this first-of-its-kind medicine to people who need more options."
The submission for the drug is supported by data from the Phase II M13-982 study assessing the safety and efficacy of the therapy in patients with relapsed, refractory or previously untreated CLL with 17p deletion. Study data unveiled last month illustrated a clinically meaningful response in nearly 80 percent of patients, including complete responses in 7.5 percent of patients, while no unexpected safety signals were observed.
Last May, the FDA awarded breakthrough therapy status to venetoclax for the treatment of CLL in patients with the p17 deletion. Roche added that the marketing authorisation application of the therapy has been validated by the European Medicines Agency.
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