Posted by Michael Wonder on 07 Oct 2023
Janssen submits application to the European Medicines Agency for Rybrevant (amivantamab) in combination with chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer with activating EGFR exon 20 insertion mutations
6 October 2023 - Type II extension of indication application is supported by data from PAPILLON, the first randomised Phase 3 study to read out in patients with NSCLC with EGFR exon 20 insertion mutations.
Janssen today announced the submission of a Type II extension of indication application to the EMA seeking approval of Rybrevant (amivantamab) in combination with chemotherapy (carboplatin and pemetrexed) for the first-line treatment of adult patients with advanced non-small cell lung cancer with activating epidermal growth factor receptor exon 20 insertion mutations.
