BioCentury
ARTICLE | Clinical News

Gazyva obinutuzumab regulatory update

March 23, 2015 7:00 AM UTC

The U.K.’s NICE issued a final appraisal determination (FAD) recommending 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. The recommendation is only if bendamustine-based therapy is not suitable and Roche provides the drug at an undisclosed discount under a patient access scheme (PAS). The decision is in line with the second preliminary appraisal issued in December (see BioCentury, Dec. 8, 2014). Final guidance is expected in May. ...