Weigh! Amgen bluemomab was approved by FDA quickly and became the first listed bispecific antibody

Source: biological exploration: two days before December 5, 2014, the author wrote a report "bispecific antibodies: new tools for cancer treatment, layout of pharmaceutical giants in succession", and analyzed the recent progress of bispecific antibodies At present, there are more than 35 kinds of bispecific antibodies in clinical development stage, but no bispecific antibodies have been approved by FDA However, the author found that in fact, on December 3, this sentence was rewritten On December 3, the bispecific antibody blinatumomab, which is most likely to be the first listed Amgen company, was approved by the FDA The decision took only two months, five months ahead of its expected audit period! The news is undoubtedly great news for Amgen Blinatumomab is an antibody drug of bite (bispecific T-cell engager), which targets CD19 antigen on the surface of tumor cells and CD13 antigen on the surface of T cells Blinatumoma B was initially developed by cancer drug R & D company micromet In 2011, micromet company published a small-scale phase II clinical trial results of blinatumoma B The results showed that the complete remission rate of patients with acute lymphoid leukemia with small residual lesions after chemotherapy reached 80% In January 2012, Amgen acquired micromet and obtained the development right of blinatumomab In 2012, Amgen released the results of a large-scale phase II clinical trial of blinatumoma B the complete remission rate of patients with relapsed or refractory acute lymphoid leukemia after using blinatumoma B reached 43% In October this year, Amgen announced that the FDA has accepted their application (BLA) for the treatment of Philadelphia chromosome negative (pH -) recurrent / refractory precursor B-cell acute lymphoblastic leukemia In addition, FDA has granted a priority review to bluemomab, dated May 19, 2015 Now it seems that this date has no meaning In addition, blinatumomab has become the first FDA approved CD19 drug in the world The FDA's early approval decision is undoubtedly a huge good news for Amgen Because Novartis, Juno and kite are all stepping up the development of their own CD19 tumor drugs These five months will give Amgen more time to occupy the market