Chinese approval for Tagrisso for 1st-line EGFR-mutated NSCLC
China’s National Medical Products Administration (NMPA) has granted marketing authorization for Tagrisso (osimertinib) as a first-line treatment for adults with locally-advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have the genetic mutations of epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitutions.
The approval, granted to AstraZeneca (LSE: AZN), 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.
Tagrisso is proving to be an important revenue generator for the Anglo-Swedish pharma major, with sales in the second quarter of this year coming in at $784 million, nearly double of that achieved in the like period a year ago.
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