AstraZeneca gets FDA breakthrough therapy designation for Tagrisso

The BTD designation granted by the US Food and Drug Administration (FDA) is indicated for the treatment of metastatic NSCLC patients who are growth factor receptor (EGFR) mutation-positive.

It was given based on the data submitted from a phase 3 trial named FLAURA which evaluated osimertinib against standard-of-care EGFR tyrosine kinase inhibitor (TKI) therapy.

The phase 3 trial was carried out in patients with locally-advanced or metastatic EGFR mutation-positive NSCLC who did not receive any prior treatment for their condition.

Osimertinib recorded 18.9 months for median progression-free survival compared to 10.2 months achieved by erlotinib or gefitinib which are standard-of-care EGFR-TKIs.

AstraZeneca also reported that improvements were recorded in patients with and without brain metastases and all other pre-specified subgroups who received osimertinib treatment in the FLAURA trial.

A third generation and irreversible EGFR-TKI, osimertinib can inhibit EGFR sensitising and EGFR T790M resistance mutations with activity in the central nervous system (CNS).

AstraZeneca global medicines development executive vice president and chief medical officer Sean Bohen said: “The Breakthrough 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.

“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.”

Currently, Tagrisso is approved in over 50 countries like the US, EU member states, Japan and China as a second line of treatment for advanced NSCLC patients whose disease progressed after treatment with an EGFR-TKI due to the EGFR T790M resistance mutation.

Image: Tagrisso got the BTD designation for first line treatment of metastatic EGFR mutation-positive NSCLC. Photo: courtesy of AstraZeneca.