According to the financial news app Intelligence Finance, on June 25th, the National Medical Products Administration (NMPA) of China announced on its official website that AstraZeneca's application for a new indication of sorafenib tosylate tablets has been approved for marketing. Osimertinib is an irreversible third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) developed by AstraZeneca. It is reported that the newly approved indication of this drug is its use as a first-line treatment for EGFR-mutated advanced non-small cell lung cancer (NSCLC) combined with chemotherapy.

Currently, osimertinib has been approved for use as a monotherapy in more than 100 countries and regions, including the United States, the European Union, China, and Japan. The approved indications include first-line treatment for locally advanced or metastatic EGFRm non-small cell lung cancer patients, second-line treatment for locally advanced or metastatic EGFR T790M-positive non-small cell lung cancer patients, and adjuvant therapy for early-stage EGFRm non-small cell lung cancer. In addition, the drug has also been approved for use in combination with chemotherapy for first-line treatment of locally advanced or metastatic EGFRm non-small cell lung cancer patients in the United States and some other countries.

It is reported that the approval of osimertinib's new indication this time is mainly based on the results of the global multicenter phase III study FLAURA2. In September 2023, AstraZeneca announced the results of the phase III clinical study FLAURA2 at the 2023 World Lung Cancer Congress (WCLC) hosted by the International Lung Cancer Research Association(IASLC). The results showed that:

Compared with osimertinib monotherapy, osimertinib combined with chemotherapy reduced the risk of disease progression or death by 38%;

The results evaluated by the researchers showed that compared with osimertinib monotherapy, osimertinib combined with chemotherapy prolonged the median progression-free survival (PFS) of patients by 8.8 months, which is consistent with the PFS results evaluated by the blinded independent central review committee (BICR) - osimertinib combined with chemotherapy prolonged the median PFS of patients by 9.5 months;

In addition, clinically significant improvements in PFS were observed in all prespecified subgroups, regardless of patient gender, race, EGFR mutation type, age at diagnosis, smoking history, or baseline presence of central nervous system metastasis.