NEW YORK – AstraZeneca on Monday said the European Commission approved its tyrosine kinase inhibitor Tagrisso (osimertinib) as a treatment for patients with advanced, unresectable non-small cell lung cancer with EGFR exon 19 deletions or exon 21 L858R substitution mutations.
Patients whose disease has not progressed during or after platinum-based chemoradiation therapy will be eligible for treatment with Tagrisso. EGFR-mutated disease accounts for 10 percent to 15 percent of all NSCLC in Europe, and of that group, 1 in 5 will have an unresectable tumor. Tagrisso is the first targeted therapy approved for European patients with unresectable EGFR-mutated lung cancer.
The approval follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use. The commission based its decision on results from the Phase III LAURA clinical trial in which Tagrisso reduced the risk of disease progression or death by 84 percent compared to placebo. Patients on Tagrisso survived a median 39.1 months without disease progression or death, compared to 5.6 months for patients on placebo. Overall survival results from the trial are not yet mature.
"Today's approval marks a major breakthrough for patients in the EU with unresectable, EGFR-mutated non-small cell lung cancer, delivering the first targeted treatment in this setting," Manuel Cobo, an oncologist at Carlos Haya University Hospital in Spain and trial investigator said in a statement. "[Tagrisso] reduced the risk of disease progression or death by an unprecedented 84 percent in the LAURA trial, setting a new benchmark for outcomes and underscoring the importance of testing for EGFR mutations upon diagnosis."
The US Food and Drug Administration approved Tagrisso in this same setting in September. The drug has previously been approved as a first-line treatment for metastatic EGFR-mutated NSCLC and as a later-line therapy for EGFR T790M-mtuated NSCLC in the US, EU, and other countries. It is also approved as adjuvant treatment after tumor resection and in locally advanced or metastatic EGFR-mutated NSCLC in combination with chemotherapy.