Venclexta (venetoclax) in combination with azacitidine was granted Breakthrough Therapy Designation from FDA for the treatment of adult patients with previously untreated intermediate, high- and very high-risk myelodysplastic syndromes based on the revised International Prognostic Scoring System.
This designation was granted based on interim results from the phase Ib M15-531 study investigating Venclexta plus azacitidine in people with previously untreated, higher-risk MDS.
This is the 38th BTD for Genentech’s portfolio of medicines, and the 11th designation for its hematology portfolio.
Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group.
