Gazyva obinutuzumab regulatory update

FDA approved an sBLA from Roche’s Genentech unit for Gazyva obinutuzumab to treat chronic lymphocytic leukemia (CLL) in combination with chlorambucil in previously untreated patients to include data from Stage 2 of the Phase III CLL11 (BO21004) trial. The open-label, international study compared the combination vs. Rituxan rituximab plus chlorambucil for the approved indication (see BioCentury, Nov. 11, 2013). The glycoengineered humanized mAb against CD20 is approved in the EU as Gazyvaro (see BioCentury, Aug. 4, 2014). ...