Pfizer Ogaituzumab for Injection Approved in China to Treat Leukemia

According to the latest announcement by the National Food and Drug Administration (NMPA), Pfizer's application for Ogaituzumab for injection (previous name: Ogaituzumab for injection) has been approved in China

Screenshot source: NMPA official website

Ogaituzumab (inotuzumab ozogamicin) is an innovative ADC developed by Pfizer.

In August 2017, Ogaituzumab was approved by the U.

In China, the marketing application of Ogaituzumab was accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China in January 2020, and was included in priority review due to "innovative drugs with obvious therapeutic advantages"

According to the clinical data when Ogaituzumab was approved for this indication in the United States, in the treatment of adult relapsed or refractory B-cell precursor acute lymphoblastic leukemia, compared with chemotherapy group, Ogaituzumab The monoclonal antibody group can significantly improve the patient's complete response rate (CR) and prolong the patient's median overall survival

Acute lymphocytic leukemia is an extremely aggressive leukemia with a very poor prognosis in adult patients

Reference materials:

[1] Information to be obtained for the drug approval certificate issued by the State Drug Administration of China on December 22.