Roche announced that the EU Committee for Medicinal Products for Human Use (CHMP) recommended that the European Commission approve Gazyvaro in combination with chlorambucil for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL) who have comorbidities making them unsuitable for a certain type of chemotherapy (full-dose fludarabine). Gazyvaro is marketed as Gazyva in the United States and the rest of the world.

 

“We are delighted the CHMP has recognized the strength of the Gazyvaro data established in the CLL11 study,” said Sandra Horning, Roche’s chief medical officer and head of global product development. “Typically, around half of patients diagnosed with CLL have comorbidities that make full-dose fludarabine based treatment unsuitable for them. We are pleased to be one step closer to making Gazyvaro available as a new foundation of treatment for their disease.”

 

The CHMP opinion is based primarily on data from the Phase 3 CLL11 study that was conducted in close collaboration with the German CLL Study Group. The study showed that Gazyvaro plus chlorambucil met its primary endpoint by significantly lengthening the amount of time people lived without their disease worsening (progression free survival; PFS) compared to chlorambucil alone and compared to MabThera (rituximab) plus chlorambucil while also increasing the depth of remissions as measured by Minimal Residual Disease (MRD)

 

Gazyvaro plus chlorambucil also increased survival time for previously untreated CLL patients compared to those who received treatment with chlorambucil alone. Data from the study was recently published in the New England Journal of Medicine.

 

Roche expects a final decision from the European Commission in the coming months.