Micrograph of a squamous carcinoma, a type of non-small-cell lung carcinoma. Credit: Nephron.

The European Medicines Agency (EMA) has accepted AstraZeneca’s variation to the marketing authorisation application (MAAv) submission for Tagrisso (osimertinib) to treat patients with non-small-cell lung cancer (NSCLC).

The therapy has been accepted for first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumours have epidermal growth factor receptor (EGFR) mutations (exon 19 deletions or exon 21 (L858R) substitution mutations).

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Tagrisso is a third-generation, irreversible 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.

Tagrisso is currently also being investigated in the adjuvant setting and in combination with other treatments.

“Tagrisso is a third-generation, irreversible EGFR tyrosine kinase inhibitor (TKI) with clinical activity against central nervous system (CNS) metastases.”

AstraZeneca’s MAAv submission for Tagrisso is based on the data obtained from the double-blinded, randomised Phase III FLAURA trial.

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The trial, involving 556 patients across 29 countries, assessed the efficacy and safety of Tagrisso 80mg once daily compared to current first-line EGFR-TKIs.

The study showed that the AstraZeneca drug significantly improved progression-free survival (PFS) compared to EGFR-TKIs, erlotinib or gefitinib, in previously untreated patients with locally advanced or metastatic EGFR mutation-positive (EGFRm) NSCLC.

AstraZeneca has also submitted a supplemental new drug application (sNDA) to Japan’s Pharmaceuticals and Medical Devices Agency for the use of Tagrisso for the first-line treatment of patients with inoperable or recurrent EGFRm NSCLC.

In addition, the company has entered a strategic joint venture (JV) with the Chinese Future Industry Investment Fund (FIIF) to form an equally owned, stand-alone company in China to discover, develop and commercialise potential new medicines to help meet unmet needs globally.