How Much Do You Know About the First Bispecific Antibody Approved by FDA?

It is reported that the market value of bispecific antibody will reach 4.4 billion US dollars by 2023. Because of the great potential in this market, pharmaceutical giants are striving to share this cake.

Different from fab antibody, bispecific antibodies can work as a vector to redirect immune effector cells by simultaneously identifying two targets, such as natural killer cell and T cell, which enhance the killing ability on tumor cells. In addition, by targeting two different receptors on the same cell, bispecific antibodies can induce changes in cellular signals, including cancer spread signals or inflammatory signals.

The therapeutic potential of bispecific antibodies has led to a number of biotech companies conducting related studies. There are more than 35 bispecific antibodies are in clinical development, but no bispecific antibodies have approved by the US Food and Drug Administration. However, that’s the case before December 3, 2014.

On December 3, Blinatumomab of Amgen, the one that most likely to be the first FDA approved bispecific antibody, received a YES from FDA. This decision which is expected to go through a-five-month review took only two months to make. It is undoubtedly a breaking news to Amgen.

Blinatumomab is a bispecific T cell engager (BiTE) antibody drug that targets CD19 antigen on the surface of tumor cells and CD13 antigen on the surface of T cells.

Blinatumomab was initially developed by Micromet, an anti-cancer drug research and development company. In 2011, Micromet released a small phase II Blinatumomab clinical trial result showing that minimal residual disease after chemotherapy in acute lymphoblastic leukemia patients got a complete remission rate of 80% with the use of Blinatumomab.

In January 2012, Amgen acquired Micromet, obtaining the right to develop Blinatumomab. In the same year, Amgen announced a large-scale Phase II clinical trial result of Blinatumomab, showing that patients with relapsed or refractory acute lymphoblastic leukemia got a complete remission rate of 43%.

In October 2014, Amgen announced that the FDA has accepted their Biologics License Application (BLA) for the treatment of Philadelphia chromosome-negative (Ph-) recurrent/refractory precursor B-cell acute lymphoblasts leukemia. What’s more, the FDA granted the priority review of blinatumomab, which dated May 19, 2015. While, this date now turns out pointless.