AstraZeneca has secured marketing clearance from the European Commission (EC) for its Tagrisso (osimertinib) drug to treat non-small cell lung cancer (NSCLC) in adults.
The authorisation allows the use of Tagrisso monotherapy as a first-line treatment in patients, having activating epidermal growth factor receptor (EGFR) mutations.
Tagrisso is a third-generation, irreversible EGFR tyrosine kinase inhibitor (EGFR-TKI) being developed to block EGFR-sensitising, as well as EGFR T790M-resistance mutations. The drug is also said to possess clinical activity towards CNS metastases.
AstraZeneca executive vice-president and oncology division head 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 first-line setting.”
The approval from the EC is based on safety and efficacy findings from the FLAURA, AURA3, AURA and AURA2 clinical trials, during which Tagrisso was observed to be well-tolerated and demonstrated progression-free survival.
Previously, the regulatory authority approved the drug for treating locally advanced or metastatic EGFR T790M mutation-positive NSCLC. This indication is available in more than 75 countries.
As the first-line treatment of patients with metastatic EGFR-mutated (EGFRm) NSCLC, Tagrisso also gained approval in the US, Brazil and the Russian Federation. Japanese regulatory review for this setting is currently underway and a decision is expected to be available over the coming months.
The drug is also being evaluated in the adjuvant setting, as well as in combination with other therapies.