AstraZeneca’s Tagrisso (osimertinib) has been approved by the European Commission (EC) to treat a new subset of lung cancer patients.
The epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor has now been authorised to treat locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express EGFR exon 19 deletions or exon 21 substitution mutations.
Patients eligible for the drug will also have not experienced disease progression during or following concurrent or sequential platinum-based chemoradiation therapy.
More than 450,000 people are diagnosed with lung cancer each year in Europe, with NSCLC accounting for up to 85% of all cases.
As many as 15% of NSCLC patients in Europe have EGFR mutations and, as a result, are particularly sensitive to treatment with an EGFR-tyrosine kinase inhibitor that blocks the cell-signalling pathways driving tumour cell growth.
The EC’s latest decision on Tagrisso follows a recent recommendation from the European Medicines Agency’s human medicines committee and was supported by positive results from the late-stage LAURA trial.
Tagrisso was shown to reduce the risk of disease progression or death by 84% compared to placebo, and median progression-free survival was 39.1 months in Tagrisso-treated patients versus 5.6 months for those receiving placebo.
Dave Fredrickson, executive vice president, oncology business unit, AZ, said: “Tagrisso is now the first and only EGFR inhibitor and targeted treatment approved in the EU for locally advanced, unresectable lung cancer, providing a new standard of care to patients who have historically experienced early progression after chemoradiation therapy.
“The powerful results from the LAURA trial show Tagrisso improves outcomes for patients in the unresectable setting, reinforces the importance of timely EGFR testing and solidifies Tagrisso as the backbone therapy in EGFR-mutated NSCLC.”
The decision comes just a few months after the EC approved Tagrisso for use alongside pemetrexed and platinum-based chemotherapy as a first-line treatment for adults with locally advanced EGFR-mutated NSCLC whose tumours have exon 19 deletions or exon 21 mutations.
The July approval was based on results from the phase 3 FLAURA2 trial, in which Tagrisso plus chemotherapy reduced the risk of disease progression or death by 38% compared to Tagrisso monotherapy.