Posted by Michael Wonder on 07 Mar 2019
Genentech submits supplemental new drug application to FDA for Venclexta plus Gazyva for previously untreated chronic lymphocytic leukaemia with co-existing medical conditions
7 March 2019 - Combination was granted breakthrough therapy designation, the fifth for Venclexta.
Genentech today announced the submission of a supplemental new drug application to the U.S. FDA for Venclexta (venetoclax) in combination with Gazyva (obinutuzumab) in people with previously untreated chronic lymphocytic leukaemia (CLL) and co-existing medical conditions.
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.
Breakthrough therapy designation was granted based on results of the randomised 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.
