21 December 2023 - The submission is supported by data from the Phase 3 MARIPOSA study, which featured in a Late-Breaking Presidential Symposium session at the 2023 ESMO Congress.
Janssen today announced the submission of a marketing authorisation application to the EMA seeking approval of lazertinib, in combination with Rybrevant (amivantamab), for the first-line treatment of adult patients with advanced non-small cell lung cancer with common epidermal growth factor receptor (EGFR) mutations including exon 19 deletions or exon 21 L858R substitution mutations.