Roche files Venclexta plus Gazyva in CLL

Roche has filed Venclexta (venetoclax) in combination with Gazyva (obinutuzumab) with the FDA for a new front line use in patients with previously untreated chronic lymphocytic leukaemia (CLL) and co-existing medical conditions.

Venclexta (Venclyxto outside the US) is co-marketed by AbbVie and Roche and if approved, the combination with Gazyva in first line treatment of CLL could see its use expanded greatly.

The drug is one of a new generation of CLL treatments now expanding into frontline use. Roche’s marketing partner AbbVie has a stake in a direct rival, Imbruvica, which it co-markets with J&J.

In January, Imbruvica gained approval in first line treatment in combination with Gazyva, making it the first non-chemo combination in this setting.

Chemotherapy-free treatment for these previously untreated patients is the new paradigm the competitors are pushing for, with trials showing advances over the standard therapy.

However, the added cost of this shift, and the availability of biosimilar rituximab (Gazyva’s precursor) will raise cost effectiveness objections from European payers.

The combination will open up new options for those patients who are ineligible for chemotherapy treatment, however.

Sandra Horning

"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.

Roche also announced that the new combination had been selected for appraisal under the new FDA Real-Time Oncology Review pilot programme, which is aiming to develop more fast and efficient ways to review treatments.

Horning added: "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."

The combination has already been awarded Breakthrough Therapy Designation based on the phase 3 CLL14 study of Venclexta plus Gazyva, compared to Gazyva plus chlorambucil in 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, with a good safety profile.