New indication for AstraZeneca osimertinib is about to be approved

Recently, the official website of the State Food and Drug Administration showed that AstraZeneca's application for the new indication for osimertinib mesylate tablets (acceptance number: JXHS2000150/JXHS2000151) has been in the "under review" stage and is expected to be approved by the NMPA in the near future.

Osimertinib is an irreversible third-generation EGFR tyrosine kinase inhibitor, which can simultaneously inhibit EGFR sensitive mutations and EGFR-T790M resistance mutations.

Osimertinib was first approved in China in March 2017 for the treatment of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) during or after treatment with disease progression, and the presence of EGFR was confirmed by testing Adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) positive for the T790M mutation.

In December 2020, based on ADAURA research data, osimertinib was approved in the United States for the use of epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R mutation in non-small cell lung cancer (NSCLC) adult patient tumors Adjuvant treatment after resection.

The results of the Phase III study code-named ADAURA showed that in the main analysis population of patients with stage II and IIIA EGFRm non-small cell lung cancer, as well as in the key secondary study endpoints of the total study population of IB-IIIA patients, osimertinib Shows statistically different and clinically significant disease-free survival (DFS) benefits.

Adjuvant osimertinib can reduce the risk of recurrence or death of DFS disease by 83% in patients with stage II and IIIA, the primary endpoint (hazard ratio [HR] 0.