Tagrisso Receives Priority Review in the US for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer

Strategic Insights -

AstraZeneca's Tagrisso (osimertinib) has received acceptance for its supplemental New Drug Application (sNDA) and has been granted Priority Review in the US for the adjuvant treatment of patients with early-stage (IB, II, and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumour resection with curative intent. This decision was based on unprecedented results from the ADAURA Phase III trial, which showed that treatment with Tagrisso reduced the risk of disease recurrence or death by 80% in Stage II and IIIA patients.

Key Takeaways:

  • The FDA grants Priority Review to applications for medicines that offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance.
  • The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is during the first quarter of 2021.
  • The ADAURA trial enrolled 682 patients with Stage IB, II, IIIA EGFRm NSCLC following complete tumour resection and adjuvant chemotherapy as indicated.
  • The trial demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS) in the primary analysis population of patients with Stage II and IIIA EGFRm NSCLC, and also in the overall trial population of patients with Stage IB-IIIA disease.
  • The results showed that treatment with Tagrisso reduced the risk of disease recurrence or death by 80% in Stage II and IIIA patients.
  • The FDA has granted Breakthrough Therapy Designation to Tagrisso in this setting.
  • AstraZeneca has a comprehensive portfolio of approved and potential new medicines in late-stage development for the treatment of different forms of lung cancer.

Statistics:

  • 80%: The risk of disease recurrence or death was reduced by 80% in Stage II and IIIA patients treated with Tagrisso.
  • 30%: Up to 30% of all patients with NSCLC may be diagnosed early enough to have potentially curative surgery.
  • 25-30%: Approximately 25-30% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFRm NSCLC.
  • 200+ centres: The ADAURA trial enrolled patients from over 200 centres across more than 20 countries.
  • 3 years: Patients were treated with Tagrisso 80mg once-daily oral tablets or placebo for three years or until disease recurrence.

Sources:

  • M2 PressWIRE (October 20, 2020)
  • AstraZeneca (astrazeneca.com)
  • American Society of Clinical Oncology (ASCO) (asco.org)
  • The New England Journal of Medicine (nejm.org)
  • International Agency for Research on Cancer (IARC) (iarc.fr)
  • LUNGevity Foundation (lungevity.org)
  • World Health Organization (WHO) (who.int)
  • Archives Pathology Lab Med (journals.lww.com)
  • Ann Oncol (onlinelibrary.wiley.com)
  • Chest (journal.chestnet.org)