AstraZeneca shares edged up nearly 1% on Monday morning in London and Stockholm after it scored a new regulatory win for its blockbuster lung cancer drug Tagrisso in the European Union. The British pharmaceutical giant's Tagrisso, or osimertinib, was approved by the European Commission for the treatment of locally advanced, unresectable non-small cell lung cancer in adults.
Lung cancer remains the leading cause of cancer-related deaths worldwide, accounting for roughly one-fifth of cancer mortality in both men and women. The Commission's approval for Tagrisso followed a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use.
The decision was backed by data from the Laura phase 3 trial, which evaluated progression-free survival in 216 NSCLC patients, whose disease had not progressed during or following definitive platinum-based chemoradiation therapy. The results showed that Tagrisso reduced the risk of disease progression or death by 84% compared with placebo.
Patients treated with the drug achieved a median progression-free survival of 39.1 months, far outpacing the 5.6 months reported for placebo recipients. AstraZeneca stated it will continue the randomized, double-blind, and placebo-controlled trial to assess the secondary endpoint of overall survival. "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 non-small cell lung cancer," said Dave Fredrickson, executive vice president of AstraZeneca's oncology business unit. Tagrisso was recently approved in the US, Switzerland, South Korea and Australia.
Meanwhile, regulatory reviews are underway in China, Japan, and several other countries..