Posted by Michael Wonder on 25 Aug 2023
Janssen submits supplemental biologics license application to the US FDA seeking approval of Rybrevant (amivantamab-vmjw) in combination with chemotherapy for the first-line treatment of patients with locally advanced or metastatic EGFR exon 20 insertion mutation positive non-small cell lung cancer
25 August 2023 - Application is supported by data from PAPILLON, the first randomised Phase 3 study to show clinically meaningful results in patients with non-small-cell lung cancer with EGFR exon 20 insertion mutations.
Janssen announced today the submission of a supplemental biologics license application to the US FDA seeking the expanded approval of Rybrevant (amivantamab-vmjw) in combination with chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations.
