US regulators are undertaking a speedy review of AstraZeneca's application to market Tagrisso as first-line treatment for lung cancer.
The drug giant is seeking permission to expand the drug’s uses to include first-line treatment of metastatic non-small-cell lung cancer (NSCLC) in patients whose tumours express EGFR mutations.
The submission rides on data from the Phase III FLAURA trial, in which Tagrisso (osimertinib) significantly boosted progression-free survival (PFS) compared to current 1st-line EGFR-TKIs, erlotinib or gefitinib, in previously-untreated patients with the condition.
According to the data, progression free survival in patients taking Tagrisso was 18.9 months compared to 10.2 months for those receiving the standard of care, while the objective response rate was 80 percent versus 76 percent, respectively.
“Until now, even with the therapeutic advances offered by the first- and second-generation EGFR inhibitors, less than 20 percent of EGFR mutation-positive NSCLC patients survive for five years,” said AZ’ chief medical officer commenting on the results when they were unveiled back in September.
“The FLAURA data suggest early and sustained benefit with Tagrisso that has the potential to significantly impact long-term patient outcomes and help address the considerable unmet need that remains.”
Tagrisso is a third generation, irreversible EGFR tyrosine kinase inhibitor designed to inhibit both EGFR sensitising and EGFR T790M resistance mutations and to have activity in the CNS.
The drug is already approved in several countries around the globe as a second-line treatment for patients with EGFR T790M mutation-positive advanced NSCLC.
EU regulators are also currently assessing whether it can be marketed in the first-line setting.