Regulatory Affairs

AstraZeneca gets EC nod for Tagrisso as first-line treatment for EGFR-mutated NSCLC

PBR Staff Writer Published 11 June 2018

The European Commission (EC) has approved AstraZeneca's Tagrisso (osimertinib) as monotherapy for first-line treatment of adult patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.

Tagrisso is a third-generation and irreversible EGFR-TKI designed to suppress both EGFR-sensitising and EGFR T790M-resistance mutations, with clinical activity against CNS metastases.

The approval was based on data from the phase III Flaura trial, which evaluated the efficacy and safety of Tagrisso 80mg once daily against standard-of-care EGFR-TKIs in previously-untreated patients with locally-advanced or metastatic EGFRm NSCLC.

The double-blinded and randomized trial recruited 556 patients across 29 countries.

In the EU, Tagrisso is already approved for the treatment of patients with locally-advanced or metastatic EGFR T790M mutation-positive NSCLC.

In April this year, the US Food and Drug Administration (FDA) approved Tagrisso as the first-line treatment for patients with metastatic NSCLC whose tumors have EGFR mutations. It is also approved for same indication in the Brazil and the Russian Federation.

During the same month, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion and recommended Tagrisso as the first-line treatment for patients with metastatic NSCLC.

Tagrisso 40mg and 80mg once-daily oral tablets were approved in four countries for first-line EGFRm advanced NSCLC. It was also approved in more than 75 countries for patients with EGFR T790M mutation-positive advanced NSCLC.

In Japan, Tagrisso is under regulatory assessment to be used as first-line treatment, and the decision is expected in the second half of this year.

In addition, Tagrisso is being tested in the adjuvant setting and in combination with other treatments.

AstraZeneca oncology business unit executive vice president Dave Fredrickson said: “Today’s approval is an exciting advance in bringing a potential new standard of care to patients with EGFR-mutated NSCLC in the EU.

“This milestone is also a step forward for our Company, marking another regional approval for Tagrisso in the 1st-line setting.”