The US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for the use of AstraZeneca’s Tagrisso (osimertinib).
It has been made clear by the company’s representatives that the sNDA is for Tagrisso as a 1st- line treatment for EGFR mutation-positive metastatic advanced NSCLC, but Tagrisso is not yet approved for this indication. Currently, it is approved in more than 60 countries, including the EU, for patients with EGFR T790M mutation-positive advanced NSCLC.
The FDA has granted Tagrisso Priority Review status and previously granted Breakthrough Therapy Designation in the 1st-line treatment of patients with metastatic EGFR mutation-positive (EGFRm) NSCLC.
The submission acceptance is based on data from the Phase III FLAURA trial, in which Tagrisso significantly improved progression-free survival (PFS) compared to current 1st-line EGFR-TKIs, erlotinib or gefitinib, in previously-untreated patients with locally-advanced or metastatic EGFRm NSCLC.
On 28 September 2017, the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology were updated to include the use of Tagrisso in the 1st-line treatment of patients with metastatic EGFRm NSCLC. The use of Tagrisso in this indication is not yet approved by the FDA.
Image: The logo of AstraZeneca is seen on a medication package in a pharmacy in London, Britain, April 28, 2014. REUTERS/Stefan Wermuth/File Photo