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31 monoclonal antibodies to watch for in 2018
Source:药事纵横 | Author:pro954f45 | Published time: 2018-01-14 | 2977 Views | Share:

       Avelumab
       Avelumab (Bavencio, MSB0010718C), a human IgG1 monoclonal antibody targeting PD-L1, was first approved on May 23, 2017. The indications approved were metastatic Merkel-cell carcinoma in adults and children over 12 years of age. The indication was also approved in Europe in September 2017. Avelumab was approved based on data from the Javelin Merkel 200 study (NCT02155647), A key phase II clinical trial in which Part A patients underwent chemotherapy prior to initial treatment with Avelumab in Part B. At a dose of 10mg/kg, intravenous injection is given fortnightly. In Part A, 88 patients who had undergone prior chemotherapy were treated with this product and their conditions were controlled. The median follow-up period was 10.4 months, and the objective remission rate was 31.8%, among which 8% had complete remission and 20% had partial remission. In Part B, 39 patients were treated for the first time with this product, and data on the median remission time of the primary endpoint is expected to be available in September 2019. Avelumab has previously been granted orphan status for Merckle cell cancer in Europe and Australia, as well as FDA breakthrough therapy designation. On May 9, 2017, THE FDA granted Avelumab a priority review of indications for locally advanced or metastatic urothelial carcinoma that has progressed after platinum chemotherapy. In addition, four phase III clinical trials of the product for non-small cell lung cancer, renal cell cancer, ovarian cancer and gastric cancer will be completed in 2018 and have been awarded orphan drug status for gastric cancer in both the United States and Europe.