AZ's Tagrisso under review in U.S. for first-line EGFR-mutant NSCLC

AstraZeneca plc (LSE:AZN; NYSE:AZN) said FDA accepted for review an sNDA for Tagrisso osimertinib (AZD9291) as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR mutations, which include exon 19 deletions or exon 21 (L858R) substitution mutations. AstraZeneca declined to disclose the candidate's PDUFA date.

Tagrisso is also under review in Europe as a first-line treatment for adults with locally advanced or metastatic, EGFR-mutant non-small cell lung cancer (NSCLC) (see BioCentury, Dec. 7)...