The company has received marketing authorisation from China’s National Medical Products Administration (NMPA) for Tagrisso (osimertinib) as a 1st-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.

The 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.

“The FLAURA trial has demonstrated the potential of Tagrisso as a new standard of careand as an important new 1st-line treatment option for non-small cell lung cancer patients in China, where approximately 30-40% are diagnosed with an EGFR mutation – more than any other country in the world,” says Dave Fredrickson, Executive Vice President, Oncology, AstraZeneca.

Photo of Dave Fredrickson: AstraZeneca