CHMP Recommends Roche's Gazyvaro For CLL

Roche announced that the EU Committee for Medicinal Products for Human Use (CHMP) gave a positive recommendation for Gazyvaro (obinutuzumab) plus chlorambucil for treatment-naïve adult patients suffering from chronic lymphocytic leukemia (CLL) with comorbidities who are unsuitable for full-dose fludarabine chemotherapy.

Sandra Horning, Roche’s CMO and Head, Global Product Development, said, “We are delighted the CHMP has recognized the strength of the Gazyvaro data established in the CLL11 study. 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.”

Chronic lymphocytic leukemia is the most prevalent type of leukemia in the Western world. The disease accounts for an estimated 10,000 deaths across Europe every year.

Gazyvaro (brand name Gazyva in the U.S.) is a novel monoclonal antibody designed to bind to B cell protein CD20. The drug attacks targeted cells directly and works with the body’s immune system to fight the diseased cells. The FDA approved obinutuzumab in combination with chlorambucil for previously untreated chronic lymphocytic leukemia in November 2013. The drug is also being investigated worldwide under a clinical program, including multiple head-to-head phase III studies versus MabThera/Rituxan in indolent non-Hodgkin lymphoma (NHL) and diffuse large B-cell lymphoma (DLBCL).

The recommendation was supported by data from the pivotal Phase III CLL11 study, where patients treated with Gazyvaro (obinutuzumab) plus chlorambucil lived longer without the disease worsening. The drug also increased survival time for treatment-naïve CLL patients versus treatment with chlorambucil alone. Results from the study were published in the New England Journal of Medicine.

The company says it expects a final decision from the European Commission regarding its application for Gazyvaro in the next few months.