Canada Approves AstraZeneca's Tagrisso for NSCLC

AstraZeneca has received Health Canada’s Notice of Compliance (NOC) for Tagrisso (osimertinib) in combination with pemetrexed and platinum-based chemotherapy for the treatment of epidermal growth factor receptor (EGFR)-mutated lung cancer. This approval is specifically for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying particular EGFR mutations.

The decision from Health Canada is supported by findings from the FLAURA2 Phase III clinical trial. This study demonstrated that combining Tagrisso with chemotherapy reduced the risk of disease progression or death by 38% compared to using Tagrisso alone. The trial was a randomized, open-label, multi-center, global investigation, engaging 557 patients from 150 centers across 20 countries, including three centers in Canada.

Patients treated with the combined therapy showed a median progression-free survival (PFS) of 25.5 months, which is an 8.8-month improvement over the 16.7 months observed with Tagrisso monotherapy. The safety profile of the combination therapy aligned with the known profiles of the individual drugs. Although adverse event rates were higher in the combination therapy group, attributed mainly to the chemotherapy components, both treatment groups had low discontinuation rates due to adverse events.

Common adverse reactions in the combination therapy group included decreases in leukocytes, platelets, and neutrophils, as well as rash and diarrhea. Grade 3 and above adverse reactions consisted of significant decreases in neutrophils and leukocytes. The primary endpoint of the ongoing FLAURA2 trial is PFS, with overall survival being a secondary endpoint still under evaluation.

Dr. Barbara Melosky, a clinical professor of medicine at the University of British Columbia and a medical oncologist, highlighted that the FLAURA2 trial results indicated a significantly longer period without disease progression for patients on the combination therapy compared to those on standard care. She emphasized that this approval is beneficial for both physicians and patients as it aids in matching the right patient with the most effective treatment, leading to better outcomes.

Tagrisso is a third-generation EGFR-TKI that has been administered to 850,000 patients worldwide. Its efficacy extends to treating NSCLC, including cases with central nervous system metastases. Notably, in June 2024, Japan's Pharmaceuticals and Medical Device Agency approved the use of Tagrisso in combination with chemotherapy as a first-line treatment for adults with NSCLC.