Genentech announced the submission of a supplemental New Drug Application to FDA for Venclexta (venetoclax) in combination with Gazyva (obinutuzumab) in people with previously untreated chronic lymphocytic leukemia and co-existing medical conditions.
Genentech is a unit of Roche.
The FDA is reviewing the application under the Real-Time Oncology Review pilot program, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible.
Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the United States and commercialized by AbbVie outside of the United States.
Breakthrough Therapy Designation was granted based on results of the randomized phase III CLL14 study, evaluating the fixed-duration combination of Venclexta plus Gazyva, compared to Gazyva plus chlorambucil, in people with previously untreated CLL and co-existing medical conditions. The study met its primary endpoint and showed a statistically significant reduction in the risk of disease worsening or death (progression-free survival as assessed by investigator) compared to standard-of-care Gazyva plus chlorambucil.