23 November 2023 - The submission is supported by data from the Phase 3 MARIPOSA-2 study featured in a Late-Breaking Presidential Symposium session at the 2023 ESMO Congress and simultaneously published in Annals of Oncology.
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 treatment of adult patients with advanced non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations, after failure of prior therapy including a third-generation EGFR tyrosine kinase inhibitor.