CHMP Recommends EU Approval for AstraZeneca's Tagrisso in NSCLC

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of AstraZeneca's Tagrisso (osimertinib) for use in the European Union (EU). This recommendation is for the treatment of patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) who have specific epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations. The therapy is intended for those who have not experienced disease progression after undergoing platinum-based chemoradiation therapy (CRT).

The CHMP's positive opinion is based on data from the Phase III LAURA study, which showed that Tagrisso significantly reduced the risk of disease progression or death by 84% compared to a placebo. Patients treated with Tagrisso had a median progression-free survival (PFS) of 39.1 months, in stark contrast to the 5.6 months observed in the placebo group. Although the overall survival (OS) results are still being evaluated as a secondary endpoint, the trial continues to monitor these outcomes.

The safety profile of Tagrisso in the LAURA trial was consistent with previously known characteristics, with no new safety concerns reported. Susan Galbraith, executive vice-president of oncology research and development at AstraZeneca, stated that the recent findings further solidify Tagrisso as a fundamental therapy for patients with EGFR-mutated non-small cell lung cancer. This therapy addresses a crucial unmet need by providing an effective targeted treatment option for patients in the unresectable setting.

Galbraith emphasized that Tagrisso has shown benefits across all stages of EGFR-mutated lung cancer and represents a significant advancement in patient care. The therapy is particularly valuable for patients who urgently require innovative treatments to extend their lives.

Tagrisso's application for approval in the EU comes after its recent approval in the United States for a similar indication. Additionally, the drug is currently under review in other countries, including China and Japan, based on the findings from the LAURA trial. AstraZeneca is also exploring the use of Tagrisso in various clinical settings. This includes its evaluation as a neoadjuvant therapy in the NeoADAURA Phase III trial and as an early-stage adjuvant resectable therapy in the Phase III ADAURA2 trial.

Furthermore, in June 2024, the Japanese Pharmaceuticals and Medical Device Agency approved Tagrisso (osimertinib) in combination with chemotherapy as a first-line treatment for adults with NSCLC. This approval highlights the expanding therapeutic potential of Tagrisso in multiple clinical scenarios and its growing acceptance in the global medical community.