AstraZeneca Plc (LON:AZN), a global, science-led biopharmaceutical company, announced on Wednesday the receipt of marketing authorisation from China's National Medical Products Administration (NMPA) for Tagrisso (osimertinib) as a first-line treatment for adults with locally-advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have the genetic mutations of epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitutions.

Reportedly, this approval followed the Priority Review Pathway and is based on results from the phase III FLAURA trial, which were published in the New England Journal of Medicine.

According to the company, in the phase III FLAURA trial, Tagrisso significantly increased the time patients lived without disease progression versus the comparator. Tagrisso is the only medicine demonstrating statistically-significant overall survival benefit in this setting.

AstraZeneca announced recently that Tagrisso additionally showed a statistically-significant and clinically-meaningful improvement in overall survival in this patient population. Also, safety data for Tagrisso in the FLAURA trial were in line with those observed in prior clinical trials.

Tagrisso was approved in China in March 2017 and added to the National Reimbursement Drug List (NRDL) effective from January 2019 for the second-line treatment of adult patients with locally-advanced or metastatic EGFR T790M mutation-positive NSCLC, whose disease has progressed on or after EGFR-TKI therapy.

AstraZeneca is focused on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in the three therapy areas of Oncology, CVRM and Respiratory.