AstraZeneca’s Tagrisso has been awarded breakthrough status in the US as a first-line treatment for a specific type of non-small cell lung cancer (NSCLC), potentially speeding up its development and regulatory pathway.

The decision is based on data from the Phase III FLAURA trial, in which patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive NSCLC were treated either with Tagrisso (osimertinib) or standard-of-care EGFR tyrosine kinase inhibitor (TKI) therapy (erlotinib or gefitinib).

The results show that median progression-free survival was nearly double at 18.9 months for Tagrisso compared with 10.2 months for comparator arm. Also, AZ says improvements were seen in all pre-specified subgroups, including patients with and without brain metastases, and the drug was well tolerated.

“The Breakthrough Therapy Designation acknowledges not only Tagrisso’s potential as a 1st-line standard of care in advanced EGFR mutation-positive NSCLC, but also the significant need for improved clinical outcomes in this disease,” said Sean Bohen, executive vice president of Global Medicines Development and chief medical officer at AZ.

“The results of the FLAURA trial have the potential to redefine clinical expectations and offer new hope for patients who currently have a poor prognosis.”

Tagrisso is a third generation, irreversible EGFR tyrosine kinase inhibitor designed to inhibit both EGFR sensitising and EGFR T790M resistance mutations and to have activity in the central nervous system (CNS).

The drug has already been approved in various global territories - including the US, EU, Japan and China - for patients with EGFR T790M mutation-positive advanced NSCLC.