FDA accepts latest application for use of AstraZeneca's Tagrisso

AstraZeneca announced on Monday that the US Food and Drug Administration has accepted a supplemental New Drug Application (sNDA) for the use of Tagrisso (osimertinib) in the first line treatment of patients with metastatic non-small cell lung cancer whose tumours have epidermal growth factor receptor (EGFR) mutations.

The FTSE 100 drugmaker described Tagrisso as a third-generation, irreversible EGFR tyrosine kinase inhibitor with clinical activity against central nervous system metastases.

It said the FDA had granted Tagrisso ‘priority review’ status, and had previously granted ‘breakthrough therapy designation’ in the first-line treatment of patients with metastatic EGFR mutation-positive non-small cell lung cancer.

“The submission acceptance is based on data from the Phase III FLAURA trial, in which Tagrisso significantly improved progression-free survival compared to current first-line EGFR-TKIs, erlotinib or gefitinib, in previously-untreated patients with locally-advanced or metastatic EGFRm non-small cell lung cancer,” AstraZeneca’s board said in its statement..

The company added that on 28 September, the US National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology were updated to include the use of Tagrisso in the first-line treatment of patients with metastatic EGFRm non-small cell lung cancer.

“The use of Tagrisso in this indication is not yet approved by the FDA,” AstraZeneca noted.