Roche's Gazyvaro Approved in Europe for Patients with the Most Common Type of Leukemia

Editor’s note: A new treatment for chronic lymphocytic leukemia (CLL) has been approved in Europe, meaning that oncologists in Europe can now start prescribing it to their patients. The treatment is specifically meant for people with CLL who have not yet been treated but who have other conditions that make them unable to use standard full-dose fludarabine-based treatment. The new treatment combines a drug called Gazyvaro with the chemotherapy drug chlorambucil. Gazyvaro is an immunotherapy drug, meaning that it boosts a patient’s own immune system to fight cancer.

“Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Gazyvaro (obinutuzumab) in combination with chlorambucil chemotherapy for the treatment of people with previously untreated chronic lymphocytic leukemia who have comorbidities making them unsuitable for an intensive therapy (full-dose fludarabine based therapy). Outside of the EU and Switzerland, Gazyvaro is marketed as Gazyva.

“ ‘We are proud to make Gazyvaro available for CLL patients in Europe,’ said Sandra Horning, M.D., Roche’s Chief Medical Officer and Head, Global Product Development. ‘Gazyvaro is a new option that helps patients achieve deep responses to treatment that translate to longer lasting remissions.’ ”

“The European approval was based on the outcomes of the CLL11 study which was conducted in close collaboration with the German CLL Study Group. The study showed that Gazyvaro plus chlorambucil met its primary endpoint by significantly reducing the risk of disease worsening or death by 61% compared to MabThera/Rituxan plus chlorambucil (progression free survival; PFS). For patients in the Gazyvaro arm, median PFS was 26.7 months compared with 15.2 months for those in the MabThera/Rituxan arm (HR 0.39, CI 0.31-0.49, p<0.001).

“Additional Gazyvaro data from the CLL11 study showed higher complete response rates (21% compared with 7%) and a ten-fold increase in the percentage of people achieving minimal residual disease (MRD) negativity* (37.7% compared with 3.3%) compared to the MabThera/Rituxan arm of the study.”