EU's Committee for Medicinal Products for Human Use (CHMP)supported the use of Gazyvaro based on the phase III CLL11 study, wherein treatment with Gazyvaro (obinutuzumab) plus chlorambucil significantly reduced the risk of disease worsening or death by 86% and increased survival time for previously untreated CLL patients compared to those who received treatment with chlorambucil alone.
Roche (SIX: RO, ROG; OTCQX: RHHBY) today 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 U.S. 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, M.D., Roche’s Chief Medical Officer and Head, 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.”
Press release: http://bit.ly/RZZbaz