The US Food and Drug Administration (FDA) has authorised AstraZeneca’s Tagrisso (osimertinib) drug as a first-line treatment for metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations.
Tagrisso (osimertinib) is an oral, third-generation, irreversible EGFR-tyrosine kinase inhibitor (TKI) designed to block EGFR-sensitising as well as EGFR T790M-resistant mutations.
Once-daily 40mg and 80mg doses of the drug have been approved by the FDA for advanced NSCLC.
AstraZeneca executive vice-president and oncology business unit head Dave Fredrickson said: “Today’s FDA approval of Tagrisso in the first-line setting is an exciting milestone for patients and our company.
“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.”
The FDA decision is based on data from the Phase III FLAURA trial conducted in previously untreated subjects with locally advanced or metastatic EGFR-mutated (EGFRm) NSCLC.
Tagrisso met the primary endpoint of progression-free survival when compared to current first-line drugs, erlotinib and gefitinib, which are EGFR TKIs.The drug was well-tolerated, and the safety profile was consistent with previous data.
The FDA previously approved Tagrisso as a second-line treatment for metastatic EGFRm NSCLC patients who have progressed during or following a first-line EGFR-TKI therapy and went on to develop the secondary T790M mutation.
AstraZeneca has also submitted applications in the European Union and Japan seeking regulatory approvals for Tagrisso in the first-line setting.