CHMP recommends approval of Roche's Gazyvaro for CLL

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP)had recommended that the European Commission approves Swiss drug major Roche’s (ROG: SIX) Gazyvaro (obinutuzumab) in combination with chlorambucil for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL) who have co-morbidities making them unsuitable for a certain type of chemotherapy (full-dose fludarabine).

Gazyvaro is marketed as Gazyva in the rest of the world, including the USA where it was approved last November, in combination with chlorambucil for people with previously untreated chronic lymphocytic leukemia. Globally, Gazyvaro is also being investigated in a large clinical program, including multiple head-to-head phase III studies compared to Roche’s MabThera/Rituxan (rituximab) in indolent non-Hodgkin lymphoma (NHL) and diffuse large B-cell lymphoma (DLBCL). Roche expects a final decision from the European Commission in the coming months.

“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, global product development. “Typically, around half of patients diagnosed with CLL have co-morbidities 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,” she noted.