The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended AstraZeneca‘s Tagrisso (osimertinib) for approval in the European Union (EU) to treat individuals with locally advanced, unresectable non-small cell lung cancer (NSCLC).
The therapy is for individuals whose tumours have specific epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations, following no disease progression post-platinum-based chemoradiation therapy (CRT).
The CHMP’s positive opinion was influenced by outcomes from the Phase III LAURA study, which demonstrated that Tagrisso reduced disease progression or death risk by 84% versus placebo.
Median progression-free survival (PFS) in patients treated with Tagrisso was 39.1 months, starkly contrasting to the 5.6 months observed for the placebo arm. Although overall survival (OS) results are still maturing, the trial continues to evaluate OS as a secondary endpoint.
Tagrisso’s safety profile in the LAURA trial aligned with its known characteristics, and no safety concerns were observed.
AstraZeneca Oncology research and development executive vice-president Susan Galbraith stated: “Today’s news reinforces Tagrisso as the backbone therapy in EGFR-mutated non-small cell lung cancer, meeting the critical unmet need for an effective targeted treatment option in the unresectable setting.
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“Tagrisso has now demonstrated its benefit across all stages of EGFR-mutated lung cancer, representing a pivotal step in transforming care for patients who are urgently in need of innovative therapies that can help extend their lives.”
Tagrisso’s application follows recent approval in the US for a similar indication, with reviews also underway in countries including China and Japan based on the LAURA trial findings.
The company is also currently exploring the therapy in different clinical settings, such as the neoadjuvant in the NeoADAURA Phase III trial and the early-stage adjuvant resectable Phase III ADAURA2 trial.
In June 2024, the Japanese Pharmaceuticals and Medical Device Agency approved Tagrisso (osimertinib) plus chemotherapy as a first-line treatment for adults with NSCLC.
