FDA Approves Osimertinib for Stage III Non-Small Cell Lung Cancer (NSCLC)

The Significance of Osimertinib in NSCLC Treatment

bOsimertinib (Tagrisso; AstraZeneca) has received approval from the FDA for its second new indication this year, highlighting its importance in unresectable stage III non-small cell lung cancer (NSCLC). This irreversible third-generation tyrosine kinase inhibitor (TKI) is particularly effective for adult patients with certain EGFR mutations.

Key Findings from the LAURA Trial

Data from the ongoing phase 3 LAURA trial (NCT03521154) were pivotal for the FDA’s review process, demonstrating notable progressions in patient outcomes. Osimertinib continues to show a significant 84% reduction in disease progression or death compared to placebo.

• 39.1-month median progression-free survival (PFS) vs. 5.6-month PFS with placebo.
• 74% PFS from osimertinib at 12 months, compared to 22% with placebo.
• 65% PFS at 24 months versus 13% for placebo.

Expanding Treatment Horizons

With osimertinib's new indication, patients can expect improved outcomes and longevity following platinum-based chemoradiation therapy. It underscores the necessity for early diagnosis and genetic testing in lung cancer patients.

This approval aligns with previous approvals, including the use of osimertinib in combination with chemotherapy, demonstrating a consistent pattern of **significant enhancements** in treatment efficacy. Ongoing research aims to further validate these findings in other settings, such as neoadjuvant therapy.