Roche Receives Positive Opinion from EMA Advisory Panel for Gazyvaro

Roche reports that the EU Committee for Medicinal Products for Human Use has recommended that the European Commission approve Gazyvaro (obinutuzumab) in combination with chlorambucil for the treatment of adult patients with previously untreated chronic lymphocytic leukemia who have comorbidities making them unsuitable for a certain type of chemotherapy (full-dose fludarabine). Gazyvaro is marketed as Gazyva in the US and the rest of the world. It received FDA approval in November 2013.

Roche expects a final decision from the European Commission in the coming months. Gazyvaro/Gazyva is a monoclonal antibody designed to attach to CD20, a protein found only on B cells. It attacks targeted cells both directly and together with the body’s immune system. It was discovered by Roche Glycart AG, now known as Roche Innovation Center Zurich, a part of the company’s Pharma Research and Early Development organization. In the US, Gazyva was approved in November 2013 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 (rituximab) in indolent non-Hodgkin lymphoma and diffuse large B-cell lymphoma (DLBCL).

Source: Roche

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