Sign in Subscribe
Pharmaceutical industry

AstraZeneca's Tagrisso Receives Positive Opinion for Marketing Authorization in the European Union

Strategic Insights

— 2 min read

AstraZeneca's Tagrisso, a third-generation, irreversible EGFR-TKI, has received a positive opinion for marketing authorization in the European Union for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumour resection with curative intent. This decision is based on the unprecedented results from the ADAURA Phase III trial, which demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS) in patients with Stage II and IIIA EGFRm NSCLC.

Key Takeaways:

  • Tagrisso has shown an 80% reduction in the risk of disease recurrence or death in the ADAURA Phase III trial.
  • The trial enrolled 682 patients with Stage IB, II, and IIIA EGFRm NSCLC, who were treated with Tagrisso 80mg once-daily oral tablets or placebo for three years or until disease recurrence.
  • The primary endpoint of DFS in Stage II and IIIA patients showed a statistically significant improvement with Tagrisso.
  • The trial also showed a clinically meaningful improvement in DFS in Stage IB, II, and IIIA patients.
  • Historically, nearly half of patients diagnosed in Stage IB, and over three-quarters of patients diagnosed in Stage IIIA, have experienced recurrence within five years.
  • Dave Fredrickson, Executive Vice President, Oncology Business Unit, emphasized the importance of this positive recommendation, stating: "With no targeted treatment options currently available for early-stage lung cancer patients after surgery in the EU, recurrence rates remain unacceptably high."
  • Tagrisso is approved to treat early-stage lung cancer in more than fifteen countries, including the US and China, and additional global regulatory reviews are ongoing.

Statistical Breakdown:

  • The ADAURA trial enrolled 682 patients with Stage IB, II, and IIIA EGFRm NSCLC.
  • The primary endpoint of DFS in Stage II and IIIA patients showed a statistically significant improvement with Tagrisso (HR 0.20, 95% CI: 0.13-0.30).
  • The trial also showed a clinically meaningful improvement in DFS in Stage IB, II, and IIIA patients (HR 0.30, 95% CI: 0.20-0.45).
  • Approximately 25-30% of NSCLC patients present with resectable disease at diagnosis, and approximately 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFRm NSCLC.

Sources:

  • AstraZeneca PLC
  • The New England Journal of Medicine
  • Archives Pathology Lab Med. 2013;137:1191-1198
  • Ann Oncol. 2010;21:196-8
  • J Clin Oncol 2008;26:3552-3559
  • World Health Organization. International Agency for Research on Cancer. Lung Fact Sheet.
  • LUNGevity Foundation. Types of Lung Cancer.
  • Journal of Thorac Onc. 2016:8;S494-S497
  • Int J Clin Exp Pathol. 2013:6;2800-12
  • J Clin Oncol. 2011:29;2121-27
  • J Clin Pathol. 2013;66:79-89
  • Cancer Discov. 2014;4(9):1046-1061

Read more