Roche Gains EU Approval for Leukemia Drug Gazyvaro
Roche reports that the European Commission has approved Gazyvaro (obinutuzumab) in combination with chlorambucil chemotherapy for the treatment of people with previously untreated chronic lymphocytic leukemia who have comorbidities making them unsuitable for an intensive therapy (full-dose fludarabine based therapy). Outside of the EU and Switzerland, Gazyvaro is marketed as Gazyva.
Gazyvaro was discovered by Roche Glycart AG, a part of the company’s Pharma Research and Early Development organization. In November 2013, Gazyva became the first medicine with Breakthrough Therapy Designation approved by the US Food and Drug Administration. It was approved in combination with chlorambucil for people with previously untreated chronic lymphocytic leukemia. Globally, Gazyvaro is also being investigated in a large clinical program, including multiple head-to-head phase III studies compared to MabThera/Rituxan in indolent non-Hodgkin lymphoma and diffuse large B-cell lymphoma. Additional combination studies with small- molecule biologic modifiers are planned or underway across a range of blood cancers.