FDA to review Roche’s supplemental new drug application for Venclexta plus Gazyva

Roche has submitted a supplemental New Drug Application to the FDA for Venclexta (venetoclax) in combination with Gazyva (obinutuzumab) in people with previously untreated chronic lymphocytic leukaemia and co-existing medical conditions. It will be reviewed under the FDA’s Real-Time Oncology Review pilot programme.

Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development, said: “More than 20,000 people will be diagnosed with untreated chronic lymphocytic leukaemia in the US this year, and many are ineligible for intensive chemotherapy-based options. We are encouraged that this chemotherapy-free, fixed-duration combination is being reviewed under the FDA’s Real-Time Oncology Review pilot programme, and we are working closely with the agency to bring this new option to people with previously untreated chronic lymphocytic leukaemia as quickly as possible.”



Breakthrough Therapy Designation was granted based on results of the randomised phase III CLL14 study which met its primary endpoint and showed a statistically significant reduction in the risk of disease worsening or death versus the standard-of-care Gazyva plus chlorambucil.