Obinutuzumab

• CAS Number: 949142-50-1

Obinutuzumab ( GA101, R05072759, old name Afutuzumab, HuMab CD20 ) is a new humanized monoclonal antibody (NHL) can be used for therapy of recurrent or refractory non-Hodgkin's lymphoma. However, still lacking the approval because the pivotal trial is not yet complete. Only in America was achieved in November 2013 by the FDA because of the anticipated good results accelerated approval for the treatment of chronic lymphocytic leukemia ( CLL).

A German study with 781 patients now showed that Obinutuzumab achieved better results compared to rituximab in the treatment of comorbid patients with CLL. On average, the progression-free survival time was extended to 10 months, while the former was replaced with Obinutuzumab in the standard therapy rituximab and chlorambucil. However, it came under Obinutuzumab likely to infusion reactions and neutropenia.

Operation

GA101 ( Obinutuzumab ) acts similarly to rituximab and ofatumumab as a CD20 antibody. This drug is the first monoclonal CD20 antibody of the second generation, which was optimized with the technique of glycoengineered ( glycosylation). Characterized destruction of malignant B- lymphocytes by activation of other immune cells against cancer cells or direct triggering of cell death can be enhanced.

Application

GA101 ( Obinutuzumab ) can be used in patients with lymphatic indolent non -Hodgkin's lymphoma or treatment-resistant chronic leukemia, which are heavily pretreated. In a phase I and phase II study even patients responded to the treatment, in which rituximab showed no effect. The drug is currently being evaluated in a number of Phase III trials, including in direct comparison with rituximab.

Dosage

In a phase III trial of the German CLL Study Group will GA101 combined with chlorambucil: 1000 mg GA101 intravenously on days 1, 8 and 15 ( Cycle 1) and day 1 ( cycle 2-6 ) and 0.5 mg chlorambucil / kg body weight orally on days 1 and 15 of each cycle.