The approval targets stage III (CPNPC) tumors that exhibit either an exon 19 deletion or an exon 21 (L858R) substitution mutation in the EGFR gene. This treatment is intended for patients whose disease has not progressed during or after platinum-based chemoradiotherapy.

Prior to commencing treatment with tagrisso, a validated test is required to confirm the presence of the EGFR mutation.

Clinical Trial Results

The conditional approval was based on the outcomes of a Phase III clinical trial. The study demonstrated that Tagrisso reduced the risk of disease progression or death by 84% compared to a placebo,as determined by an independant central review.

“The Laura trial has shown that thanks to Tagrisso, patients were able to live, on average, more than three years without progression of the disease.”

The median duration of progression-free survival was 39.1 months for patients treated with Tagrisso, compared to 5.6 months for those receiving a placebo. Overall survival data is still being analyzed.

In Canada, approximately 32,000 individuals are diagnosed with lung cancer annually. NSCLC accounts for 80% to 85% of these cases, with about 15% of NSCLC patients having EGFR mutations. Nearly one in five NSCLC diagnoses involves an inoperable tumor.

Expert Commentary

“Thanks to the approval of Tagrisso, we are now able to offer people with a stadium CPNPC, with mutation in the EGFR an oral targeted treatment,” said the D^r Paul Wheatley-Price, associate professor of medicine at the University of Ottawa and medical oncologist at the Ottawa hospital, and animator of the Balado entitled “Voice of lung cancer”.

“The results of the Laura test highlight the potential advantages of Tagrisso after the CRT,” notes Nathalie Daaboul, hemato-oncologist at the integrated Cancer Center of the Montérégie of the University of Sherbrooke. “This treatment offers the hope of unprofolded progression survival and an advancement in results, which is excellent news for patients.”