Gazyva (obinutuzumab, also known as GA101) was approved by the FDA in combination with chlorambucil chemotherapy for patients with previously untreated chronic lymphocytic leukemia (CLL).
Gazyva is Roche ’s fifth anti-cancer drug approved by the FDA in the past three years. The approval of this drug will reduce biosimilars to Roche ’s blockbuster drug Rituxan (common name: rituximab, rituximab) Impact.
Prior to this, the FDA has granted Gazyva Breakthrough Therapy Designation and Priority Review to speed up drug development and approval.
Gazyva's approval was based on the results of the Phase III CLL11 trial. This study showed that compared with the chlorambucil chemotherapy group, patients with Gazyva combined with chlorambucil chemotherapy group had a 84% reduction in disease progression or death (HR = 0.16, p <0.0001), and disease-free survival The period was significantly extended (PFS = 23.0 months vs 11.1 months).
In July of this year, Roche published positive data for the CLL11 study. In an established mid-term analysis, an independent data monitoring committee found that the study reached its primary endpoint: in previously untreated chronic lymphocytic leukemia (CLL) Among patients, compared with Rituxan + chemotherapeutic drug chlorambucil, GA101 + chlorambucil significantly prolonged the progression-free survival (PFS) of the disease. The CLL11 study is currently being carried out in collaboration between Genentech and the German Leukemia Research Group (GCLLSG). The final data will be submitted to the 55th annual meeting of the American Society of Hematology in December 2013.
GA101 is the first glycosylated type II anti-CD20 monoclonal antibody, which means that specific sugar molecules in GA101 can be modified to change its interaction with human immune cells. This modification creates a unique antibody designed to be used as an immunotherapy, using the patient's own immune system to help attack cancer cells. In addition, the combination of GA101 and CD20 can directly induce cell death.
GA101 aims to enhance the antibody-dependent cellular cytotoxicity (Antibody-Dependent Cellular Cytotoxicity, ADCC) and direct cell death induction (Direct Cell Death induction).
GA101 was developed by GlyArt AG, a wholly-owned subsidiary of Roche, using its proprietary antibody modification technology, GlycoMAb technology. Both the drug and meruohua selectively target the CD20 protein on B cells. Currently, rituximab has been recommended by Japan and overseas to be included in non-Ho Chikin's lymphoma treatment guidelines.
Rituxan is a chimeric mouse / human monoclonal antibody. It is the world's first monoclonal antibody approved for clinical treatment of non-Hodgkin's lymphoma (NHL). The European patent for this drug will be at the end of 2013 maturity.
In April this year, based on the CLL11 test data, Roche has submitted GA101 marketing application to the FDA and EMA respectively.
CLL is one of the most common blood cancers, and it is estimated that nearly 5,000 people died of the disease in the United States in 2013. Patients in the CLL11 study included older CLL patients who were previously untreated, and these patients often cannot afford existing active treatment options.
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