The approval is for patients whose tumours have certain mutations have epidermal growth factor receptor (EGFR) mutations.
Tagrisso has been used as a second-line treatment in the US since last March, while the pill is still under regulatory review in the EU and Japan for use in the first-line treatment setting, with decisions expected later this year.
“Today's FDA approval of Tagrisso in the 1st-line setting is an exciting milestone for patients and our company,” Astra’s head of oncology Dave Fredrickson.
“Tagrisso delivered unprecedented median progression-free survival data across all pre-specified patient subgroups, including patients with or without CNS metastases, and could prolong the lives of more patients without their tumours growing or spreading.”
AstraZeneca shares edged 6p higher to £49.70 in early deals on Thursday.