FDA approves J&J combo therapy for lung cancer

March 4, 2024

The FDA has granted full approval to J&J's Rybrevant, in combination with chemotherapy, as a first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that presents with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

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.