Roche submits supplemental new drug application to FDA for Venclexta plus Gazyva for previously untreated chronic lymphocytic leukaemia with co-existing medical conditions

F. Hoffmann-La Roche Ltd / Roche submits supplemental new drug application to FDA for Venclexta plus Gazyva for previously untreated chronic lymphocytic leukaemia with co-existing medical conditions . Processed and transmitted by West Corporation. The issuer is solely responsible for the content of this announcement.

• Application is being reviewed under FDA's Real-Time Oncology Review pilot programme

Combination was granted Breakthrough Therapy Designation, the fifth for Venclexta

Basel, 7 March 2019 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the submission of a supplemental New Drug Application to the US Food and Drug Administration (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 programme, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible.

"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," said Sandra Horning, MD, Roche's Chief Medical Officer and Head of Global Product Development. "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, 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 [PFS] as assessed by investigator) compared to standard-of-care Gazyva plus chlorambucil. Safety for the Venclexta plus Gazyva combination appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination. Data from the CLL14 study will be presented at an upcoming medical meeting. The CLL14 study is being conducted in cooperation with the German CLL Study Group (GCLLSG), headed by Michael Hallek, MD, University of Cologne.