The recent approval upgrades the drug's May 2021 accelerated approval following the outcomes of the phase 3 PAPILLON study, which demonstrated a notable improvement in progression-free survival among this patient demographic.
The PAPILLON study's results underscored the drug’s efficacy combined with chemotherapy, highlighting a 61% reduction in the risk of disease progression or death when compared to chemotherapy alone, positioning the regimen as a potential standard-of-care for the first-line treatment of NSCLC patients with EGFR exon 20 insertion mutations. The National Comprehensive Cancer Network has updated its Clinical Practice Guidelines to recommend this combination as a preferred first-line therapy for these patients.
Lung cancer remains one of the leading causes of cancer-related deaths globally, with NSCLC accounting for the majority of cases. Patients with EGFR exon 20 insertion mutations have historically faced poorer outcomes and limited treatment benefits from existing third-generation EGFR tyrosine kinase inhibitors and chemotherapy. The full approval of Rybrevant plus chemotherapy marks a crucial development in offering a targeted treatment approach.
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