Tagrisso is a third-generation and irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with clinical activity against central nervous system (CNS) metastases. It is designed to inhibit both EGFR-sensitising and EGFR T790M-resistance mutations.
The company has submitted sNDA based on data from the phase III Flaura trial, in which Tagrisso significantly improved progression-free survival (PFS) compared against first-line EGFR-TKIs, erlotinib or gefitinib, in previously-untreated patients with locally-advanced or metastatic EGFRm NSCLC.
Tagrisso 40mg and 80mg once-daily oral tablets were approved in around 60 countries, including the US, EU, Japan and China, to treat patients with EGFR T790M mutation-positive advanced NSCLC.
It is also being studied in the adjuvant setting and in combination with other treatments.
Flaura trial evaluated the efficacy and safety of Tagrisso 80mg once daily against standard-of-care EGFR-TKIs or gefitinib in previously-untreated patients with locally-advanced or metastatic EGFR-mutated NSCLC.
The study was a double-blinded and randomised trial with around 556 patients across 29 countries.
According to the company, around 10% to 15% of patients in the US and Europe and 30% to 40% of patients in Asia have EGFRm NSCLC.
These patients are specifically sensitive to treatment with currently-available EGFR-TKIs, which block the cell-signalling pathways that enhances the growth of tumour cells.