Oncology/Hematology
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Lung Cancer
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EGFR inhibitor now indicated for unresectable stage III disease following chemoradiotherapy
by
Mike Bassett, Staff Writer, MedPage Today
September 25, 2024
The FDA has approved osimertinib (Tagrisso) for locally advanced, unresectable stage III non-small cell lung cancer (NSCLC) following chemoradiotherapy, the agency announced Wednesday.
The EGFR inhibitor is specifically indicated for adults whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiotherapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations as detected by an FDA-approved test.
Approval was based on data from the LAURA trial, the results of which were presented at the American Society of Clinical Oncology (ASCO) annual meeting in June.
In the phase III trial, median progression-free survival (PFS) increased seven-fold when patients received osimertinib after definitive chemoradiation, improving from 5.6 months with placebo to 39.1 months with osimertinib (HR 0.16, 95% CI 0.10-0.24, P
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