AstraZeneca wins U.S. FDA approval for 1st-line use of lung cancer drug
April 18 (Reuters) - AstraZeneca Plc said on Wednesday the U.S. Food and Drug Administration (FDA) has approved the 1st-line use of its lung cancer drug, Tagrisso.
The U.S. FDA approved the 1st-line use of Tagrisso to treat non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutations, the company said.
Drugs like Tagrisso are designed for patients with certain mutations on a gene called EGFR. They can hold disease at bay in these patients but cancer cells often adapt and develop new resistance mechanisms.
AstraZeneca won the full approval for Tagrisso in March last year.
The pill is under regulatory review in the European Union and Japan for use in the 1st-line treatment setting and regulatory decisions are expected in the second half of 2018, the company said. (Reporting by Mekhla Raina in Bengaluru; Editing by Sandra Maler)
