US FDA accepts sNDA for Tagrisso in first-line EGFR-mutated NSCLC

The US Food and Drug Administration has agreed to review a supplemental New Drug Application (sNDA) for the use of Tagrisso (osimertinib) for a new indication.

AstraZeneca (LSE: AZN) said the FDA had accepted the sNDA for the use of Tagrisso, a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with clinical activity against central nervous system (CNS) metastases, in the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR mutations (exon 19 deletions or exon 21 (L858R) substitution mutations).

Shares of the Anglo-Swedish drugmaker edged up 1.4% in early morning trading, but levelled off shortly thereafter.