AstraZeneca’s Tagrisso gains approval in Canada for NSCLC
AstraZeneca has obtained Health Canada’s Notice of Compliance (NOC) for Tagrisso (osimertinib) along with pemetrexed and platinum-based chemotherapy, to treat epidermal growth factor receptor (EGFR)-mutated lung cancer.
The approval is meant to be used as a first-line therapy for individuals with certain EGFR mutations who have locally progressed or metastatic non-small cell lung cancer (NSCLC). The FLAURA2 Phase III clinical study, which showed a 38% decrease in the risk of disease progression or mortality when Tagrisso was paired with chemotherapy as opposed to Tagrisso monotherapy, is the basis for Health Canada's decision. Five hundred fifty-seven patients from 150 centers in 20 countries—three in Canada—were enrolled in the open-label, randomized, multicenter, international trial. Patients receiving combination treatment had a median progression-free survival (PFS) of 25.5 months, which was 8.8 months longer than that of Tagrisso monotherapy patients at 16.7 months.