FDA Approves Osimertinib for Unresectable Stage III NSCLC Based on Phase 3 LAURA Trial Results

Thursday, 26 September 2024, 09:18

Osimertinib has received FDA approval as a treatment for unresectable stage III NSCLC, based on pivotal findings from the phase 3 LAURA trial. This approval marks a significant advancement in therapeutic options for patients with EGFR-mutated lung cancer. Data from the LAURA trial showed extended progression-free survival, underscoring the drug’s effectiveness in managing this complex condition.
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FDA Approves Osimertinib for Unresectable Stage III NSCLC Based on Phase 3 LAURA Trial Results

FDA Approves Osimertinib for Unresectable Stage III NSCLC

In a groundbreaking development, osimertinib (Tagrisso; AstraZeneca) has received FDA approval for use in adult patients with unresectable stage III non-small cell lung cancer (NSCLC). This approval is based on the findings from the ongoing phase 3 LAURA trial (NCT03521154), which demonstrated significant improvements in patient outcomes.

Significant Trial Outcomes

The LAURA trial evaluated osimertinib's effectiveness after patients underwent concurrent or sequential platinum-based chemoradiation. Critical results indicated:

  • 84% reduction in the risk of disease progression or death compared to placebo.
  • Median progression-free survival (PFS) of 39.1 months.
  • Rates of disease control reached 89% in long-term follow-up.

Notably, patients treated with osimertinib exhibited an extended duration of disease-free survival, living without disease progression for more than three years.

Continued Research

AstraZeneca’s Suresh Ramalingam, MD, highlighted the potent impact of this treatment, stating, "This approval represents a major breakthrough for patients with stage III, EGFR-mutated lung cancer. Early diagnosis remains crucial." Osimertinib is also being studied in additional trials, emphasizing its evolving role in lung cancer treatment.


This article was prepared using information from open sources in accordance with the principles of Ethical Policy. The editorial team is not responsible for absolute accuracy, as it relies on data from the sources referenced.


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