Health Canada approves Tagrisso® with the addition of chemotherapy for patients with EGFR-mutated advanced lung cancer

Health Canada has granted a Notice of Compliance (NOC) for Tagrisso® (osimertinib) in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of patients with locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.1

The approval of Tagrisso in combination with chemotherapy was granted based on the results from the FLAURA2 Phase III clinical trial, which was published in the New England Journal of Medicine in November 2023.2 Tagrisso with the addition of chemotherapy reduced the risk of disease progression or death by 38% compared to Tagrisso monotherapy which is the 1st-line global standard of care (hazard ratio [HR] 0.62; 95% confidence interval [CI] 0.49, 0.79; p<0.0001). Median progression-free survival (PFS) by investigator assessment was 25.5 months for patients treated with Tagrisso plus chemotherapy, an 8.8-month improvement versus Tagrisso monotherapy (16.7 months).