Pfizer subcutaneous injection of BCMA × CD3 dual antibody is proposed to be included in CDE priority evaluation
芊芊551
发表于 2024-1-31 15:06:31
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On January 31st, the official website of the Drug Evaluation Center (CDE) of the National Medical Products Administration announced that Pfizer has submitted an application for the marketing of Elanatamab injection in China and has been accepted. At the same time, the product is also proposed to be included in the CDE's priority review, targeting adult patients with recurrent or refractory multiple myeloma (MM) who have received at least three treatments in the past.
Elanatamab is a subcutaneous injection of BCMA × CD3 bispecific antibody has been approved by the US FDA in August 2023 for the treatment of recurrent/refractory MM patients.
According to publicly available information from Pfizer, elranatamab is a bispecific antibody that targets BCMA and CD3 through subcutaneous injection. One end of the antibody binds to BCMA on myeloma cells, while the other end binds to CD3 receptors on the surface of T cells, causing them to bind together and activate T cells to kill myeloma cells. In addition, elranatamab is used to treat patients through subcutaneous injection, which is more convenient than intravenous injection and may slow down the occurrence of potential side effects such as cytokine release syndrome (CRS).
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Disclaimer: The views expressed in this article are those of the author only, this article does not represent the position of CandyLake.com, and does not constitute advice, please treat with caution.
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