BioCentury
ARTICLE | Clinical News

Gazyva regulatory update

May 26, 2014 7:00 AM UTC

EMA's CHMP backed approval of Gazyvaro obinutuzumab from Roche to treat previously untreated chronic lymphocytic leukemia (CLL) in combination with chlorambucil in patients unsuitable for fludarabine-based therapy. Roche expects a decision from the European Commission in the "coming months." Roche already markets obinutuzumab in the U.S. as Gazyva for first-line CLL in combination with chlorambucil. ...