AstraZeneca has received Health Canada’s Notice of Compliance (NOC) for Tagrisso (osimertinib) in combination with pemetrexed and platinum-based chemotherapy.
The combination is indicated as the first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 substitution mutations.
Tagrisso is an irreversible EGFR tyrosine kinase inhibitor (EGFR -TKI) with proven clinical activity in NSCLC, including against central nervous system (CNS) metastases.
Health Canada approved Tagrisso plus chemotherapy based on the results from the FLAURA2, a randomised, open-label, multi-centre, global Phase 3 clinical trial.
The Phase 3 FLAURA2 trial enrolled 557 patients in more than 150 centres across more than 20 countries, including three centres in Canada.
In the study, Tagrisso plus chemotherapy reduced the risk of disease progression or death by 38% compared to Tagrisso monotherapy as the first-line standard of care.
The combination showed a median progression-free survival (PFS) of 25.5 months, compared with an 8.8-month improvement with Tagrisso monotherapy.
Tagrisso plus chemotherapy showed a safety profile that was consistent with the established profiles of the individual medicines.
The most common adverse reactions include a decrease in leukocytes, platelets, neutrophils, lymphocytes, rash, diarrhoea, stomatitis, paronychia, dry skin, and increased blood creatinine.
Lung Cancer Canada executive director Shem Singh said: “A lung cancer diagnosis can be devastating, and until we get better at diagnosing it earlier, those impacted by the disease need better treatment options.
“Having this new option available to Canadians living with lung cancer that effectively targets their specific type of lung cancer to help them live well longer is great news for the lung cancer community and another step in the right direction.”
University of British Columbia clinical professor of medicine and medical oncologist Barbara Melosky said: “The FLAURA2 trial showed results demonstrating that patients experienced a significantly longer time without progression than those patients on standard of care.
“This approval is great news for physicians and patients and further helps us to match the right patient to the right treatment to get the best possible outcomes.”
