ARTICLE | Clinical News

Gazyva regulatory update

October 6, 2014 7:00 AM UTC

The U.K.'s NICE issued a preliminary appraisal determination recommending against the use of Gazyvaro obinutuzumab from Roche in combination with chlorambucil as first-line therapy for chronic lymphocytic leukemia (CLL) in patients who have comorbidities making them unsuitable for full-dose fludarabine-based therapy -- its approved indication in the EU. NICE said Gazyvaro is clinically effective, but said there were "too many uncertainties" in Roche's submission and the most likely incremental cost-effectiveness ratios (ICER) were above the range NHS England typically deems cost effective. The closing date for comments is Oct. 23, with a second appraisal committee meeting scheduled for Nov. 5.

The pharma markets the glycoengineered humanized mAb against CD20 in the U.S. as Gazyva for the indication. Obinutuzumab is also in Phase III testing for non-Hodgkin's lymphoma (NHL) and diffuse large B cell lymphoma (DLBCL). Roche gained obinutuzumab, which was developed using GlycoMAb glycosylation technology, through its 2005 acquisition of Glycart Biotechnology AG. ...