Tagrisso is a third generation and irreversible EGFR-TKI, which can inhibit both EGFR sensitising and EGFR T790M resistance mutations. It is also said to have activity in the CNS.
The approval was based on results of the Phase III AURA3 trial, which showed statistically-significant improvements in progression-free survival (PFS) against standard platinum-based doublet chemotherapy in 419 patients with EGFR T790M-positive advanced NSCLC whose disease had progressed on or after EGFR TKI therapy.
In March, the US Food and Drug Administration (FDA) has granted approval for Tagrisso 80mg once-daily tablets to treat patients with EGFR T790M mutation-positive NSCLC. It also secured approval in China through the priority review pathway.
Earlier, the firm secured fast track, breakthrough therapy and priority review designation for Tagrisso from the FDA.
In addition, Tagrisso is being assessed in the adjuvant and metastatic first line settings, including in patients with and without CNS metastases, leptomeningeal metastases and combination with other treatments.
AstraZeneca global medicines development executive vice president and chief medical officer Sean Bohen said: “The full approval of Tagrisso in the EU is further evidence of our exciting progress in transforming the science of cancer care to deliver life-changing medicines to people most in need.
“Having demonstrated its superiority over chemotherapy in EGFR T790M mutation-positive non-small cell lung cancer, Tagrisso has the potential to become the new standard of care for patients with this difficult-to-treat form of lung cancer.”
Image: AstraZeneca global medicines development executive vice president and chief medical officer Sean Bohen. Photo: courtesy of AstraZeneca.