FDA approves Rybrevant for treatment of non-small cell lung cancer
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Key takeaways:
- The FDA approved a first-line treatment of EGFR-mutant non-small cell lung cancer.
- Study results showed the therapy the risk for disease progression or death compared with chemotherapy alone.
The FDA on Friday approved Rybrevant in combination with chemotherapy as the first first-line treatment of locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations, Johnson & Johnson announced.
The approval converts the May 2021 accelerated approval of Rybrevant (amivantamab-vmjw, Janssen) to a full approval.
According to Johnson & Johnson, the approval was based on findings from the randomized phase 3 PAPILLON trial, which showed that amivantamab-vmjw plus chemotherapy resulted in a 61% reduction in the risk for disease progression or death compared with chemotherapy alone.
The trial also demonstrated that treatment with amivantamab-vmjw plus chemotherapy improved objective response rate and progression-free survival.
Based on the results, the National Comprehensive Cancer Network updated its guidelines to include a category 1 recommendation for amivantamab-vmjw plus chemotherapy as a preferred first-line therapy for patients with non-small cell lung cancer with EGFR exon 20 insertion mutations.
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