FDA expands osimertinib approval for advanced non-small cell lung cancer
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The FDA approved osimertinib for treatment of certain patients with locally advanced or unresectable non-small cell lung cancer.
The indication applies to use of the agent by adults whose disease did not progress during or after sequential or concurrent platinum-based chemoradiation therapy, and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations.
Osimertinib (Tagrisso, AstraZeneca) is a third-generation EGFR-directed tyrosine kinase inhibitor. The FDA previously approved the agent for adults with advanced or metastatic EGFR-mutant NSCLC or as adjuvant therapy for resectable EGFR-mutant NSCLC.
The agency based the new indication on results of the randomized phase 3 LAURA trial.
The trial included 216 adults with locally advanced or unresectable stage III NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations whose disease did not progress during or after platinum-based chemoradiation within 42 days of study randomization.
Researchers randomly assigned patients 2:1 to 80 mg oral osimertinib once daily or placebo. Treatment continued until disease progression or unacceptable toxicity.
PFS assessed by blinded independent central review served as the primary efficacy outcome. Investigators also assessed OS.
As Healio previously reported, results presented at this year’s ASCO Annual Meeting showed an 84% reduction in risk for disease progression or death with osimertinib (median PFS, 39.1 months vs. 5.6 months; HR = 0.16; 95% CI, 0.1-0.24).
OS results remained immature at the time of analysis.
The most common adverse events observed among patients assigned osimertinib included lymphopenia, leukopenia, thrombocytopenia, interstitial lung disease/pneumonitis, neutropenia, diarrhea, rash, nail toxicity, cough, musculoskeletal pain and COVID-19 infection.
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