CHMP recommends approval of Roche’s Gazyvaro for chronic lymphocytic leukemia

May 27, 2014 9:39 AM

Roche announced that CHMP adopted a positive opinion recommending approval of Gazyvaro in combination with chlorambucil for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL) who have comorbidities making them unsuitable for full-dose fludarabine.

“We are delighted the CHMP has recognized the strength of the Gazyvaro data established in the CLL11 study,” said Sandra Horning, Roche’s Chief Medical Officer. “Typically, around half of patients diagnosed with CLL have comorbidities that make full-dose fludarabine based treatment unsuitable for them. We are pleased to be one step closer to making Gazyvaro available as a new foundation of treatment for their disease.”

The committee’s recommendation is based on the data from phase III CLL11 study. The study showed that Gazyvaro plus chlorambucil met its primary endpoint by significantly lengthening the amount of time people lived without their disease worsening (progression free survival; PFS) compared to chlorambucil alone and compared to MabThera (rituximab) plus chlorambucil while also increasing the depth of remissions as measured by Minimal Residual Disease. Gazyvaro plus chlorambucil also increased survival time for previously untreated CLL patients compared to those who received treatment with chlorambucil alone.

Obinutuzumab, also known as GA101, is marketed as Gazyva in the U.S. and the rest of the world. The new monoclonal antibody, like rituximab, is 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.

In the U.S., Gazyva was approved in November 2013 in combination with chlorambucil for people with previously untreated chronic lymphocytic leukemia. Roche states that, the product 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 (NHL) and diffuse large B-cell lymphoma (DLBCL).

Editor’s note:  After the successful approvals of pertuzumab (Perjeta) and TDM-1 (Kadcyla) in breast cancer area, Roche now gets the approval for GA101 in EU, which can be called as the next generation rituximab.

Roche is not against biosimilars as the CEO Severin Schwan says but the company is continuously developing new & successful  strategies against the upcoming biosimilar monoclonal antibodies in the EU & US markets. We will all see what will happen and how will Roche manage to market these new but costly therapies.

Source: Roche press release

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