AstraZeneca’s Tagrisso Recommended for EU Approval in Treating Advanced NSCLC
Monday, November 18, 2024
AstraZeneca’s Tagrisso has been recommended for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for use in adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC).
Lung cancer remains a leading cause of cancer-related deaths globally, with over 450,000 new cases reported annually in Europe. Among NSCLC cases, approximately 10-15% of patients in the region present with EGFR mutations, and a significant proportion of cases involve unresectable tumours.
Tagrisso is already approved in several countries, including the US, for similar indications. It has demonstrated benefits across various stages of EGFR-mutated NSCLC, from early-stage disease to advanced settings. Regulatory reviews for this indication are ongoing in multiple regions, including China and Japan.
This recommendation applies to individuals whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations and whose condition has remained stable following platinum-based chemoradiation therapy (CRT).
The decision is based on the Phase III LAURA trial results, published in The New England Journal of Medicine. Data from the study demonstrated a significant reduction in the risk of disease progression or death, with Tagrisso improving progression-free survival (PFS) compared to placebo. Patients treated with Tagrisso experienced a median PFS of 39.1 months versus 5.6 months for the placebo group.
The safety profile observed in the trial was consistent with previous findings, and no new safety concerns were identified. While overall survival (OS) results remain immature, ongoing analyses will continue to evaluate this secondary endpoint.
AstraZeneca continues to investigate Tagrisso’s potential in additional therapeutic areas, including its use in combination therapies and in addressing resistance mechanisms. Ongoing trials include studies in both early and advanced disease stages, aiming to expand treatment options for patients with EGFR-mutated NSCLC.
This recommendation reinforces the role of Tagrisso as a foundational therapy in EGFR-mutated NSCLC, providing an effective treatment option for patients with limited alternatives.
Source: astrazeneca.com
