AstraZeneca's Tagrisso approved by EC for NSCLC treatment

AstraZeneca has secured approval from the European Commission (EC) for its oral medication Tagrisso (osimertinib), designed to treat adults with locally advanced and non-resectable non-small cell lung cancer (NSCLC). This authorization is particularly aimed at cases where tumors show epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations, and where the disease has not advanced during or after treatment with platinum-based chemoradiation therapy (CRT).

The EC’s decision was influenced by the positive recommendation from the Committee for Medicinal Products for Human Use and is supported by findings from the Phase III LAURA trial, which was conducted across multiple centers. This study demonstrated that Tagrisso significantly reduced the risk of disease progression or death by 84% compared to a placebo, with patients experiencing a median progression-free survival (PFS) of 39.1 months. Although the overall survival (OS) data is still being assessed, the trial is continuing to focus on OS as a secondary measure. The safety profile observed in the trial was consistent with previous research, revealing no new safety issues.

Dave Fredrickson, AstraZeneca's executive vice-president of the oncology business unit, stated that Tagrisso is now the first and only EGFR inhibitor and targeted treatment approved in the EU for locally advanced, unresectable lung cancer. This offers a new standard of care to patients who have historically faced early progression following CRT. Fredrickson highlighted that the significant results from the LAURA trial not only demonstrate improved outcomes for patients in unresectable situations but also emphasize the importance of timely EGFR testing. Moreover, Tagrisso is now solidified as the foundational therapy for EGFR-mutated non-small cell lung cancer.

This latest approval represents the fifth authorization for Tagrisso based on the LAURA trial outcomes, following recent endorsements in the United States, Australia, Switzerland, and South Korea. Meanwhile, regulatory evaluations are ongoing in countries such as China and Japan, as well as others. Worldwide, Tagrisso is authorized as a standalone treatment in over 100 countries, including the EU, China, and Japan.

In a related development, Japan's Pharmaceuticals and Medical Device Agency approved Tagrisso in June for use alongside chemotherapy as a first-line treatment for adult patients with NSCLC. This decision aligns with the global trend of recognizing Tagrisso as a critical option in the management of this specific type of lung cancer. The consistent global approvals underscore Tagrisso's pivotal role in advancing treatment options for patients with EGFR-mutated lung cancer and reflect the drug's impact on extending progression-free periods for those affected by this challenging disease.