The European Commission (EC) has granted full marketing authorisation for AstraZeneca's Tagrisso for the treatment of adult patients with non-small cell lung cancer (NSCLC).
More specifically, Tagrisso is osimertinib 40mg and 80mg once-daily tablets used to treat locally-advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive NSCLC.
The EGFR T790M mutation can be detected with a validated test using either DNA derived from a biopsy or circulating tumour DNA obtained from a plasma sample.
The Tagrisso trial tested 419 patients with EGFR T790M-positive advanced NSCLC whose disease had progressed on or after EGFR TKI therapy.
Tagrisso demonstrated significant improvements in progression-free survival compared with standard platinum-based doublet chemotherapy. Among patients taking Tagrisso, the PFS was ten months, compared to four months in the chemotherapy arm.
In March 2017, the US Food and Drug Administration (FDA) granted Tagrisso a conversion from accelerated to full approval.
Tagrisso was also recently approved in China through the new Priority Review Pathway, which grants an accelerated review timeline for innovative therapies.