AstraZeneca's Osimertinib Receives NMPA Approval in China for First-Line Treatment of EGFR-Mutated Advanced NSCLC in Combination with Chemotherapy

Intelligent Finance APP learned on June 25 that the official website of China's National Medical Products Administration (NMPA) announced that the new indication marketing application for Tagrisso (osimertinib mesylate) tablets submitted by AstraZeneca (AZN.US) has been approved. Osimertinib, developed by AstraZeneca, is an irreversible third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI). It is reported that the newly approved indication for this drug is for first-line treatment in combination with chemotherapy for EGFR-mutated advanced non-small cell lung cancer (NSCLC).

Currently, Osimertinib has been approved as a monotherapy in over 100 countries and regions, including the United States, the European Union, China, and Japan. Approved indications include first-line treatment for patients with locally advanced or metastatic EGFRm non-small cell lung cancer (NSCLC), second-line treatment for patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC, and adjuvant treatment for early-stage EGFRm NSCLC. Additionally, the drug has also been approved in the United States and some other countries for use in combination with chemotherapy as a first-line treatment for patients with locally advanced or metastatic EGFRm NSCLC.

It is reported that the approval of Osimertinib for this new indication was mainly based on the results of the global multicenter Phase 3 study, FLAURA2. In September 2023, AstraZeneca announced the results of the Phase 3 clinical study FLAURA2 at the 2023 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer (IASLC). The study results showed:

Compared with osimertinib monotherapy, the combination of osimertinib and chemotherapy reduced the risk of disease progression or death by 38%.

The results assessed by the researchers showed that, compared with osimertinib monotherapy, osimertinib combined with chemotherapy extended the median PFS of patients by 8.8 months, which was consistent with the PFS results evaluated by the Blinded Independent Central Review (BICR) — osimertinib combined with chemotherapy extended the median PFS of patients by 9.5 months.

Moreover, a clinically meaningful improvement in PFS was observed across all predefined subgroups, regardless of patient gender, race, EGFR mutation type, age at diagnosis, smoking history, or the presence of central nervous system metastases at baseline.