Posted by Michael Wonder on 20 Nov 2023
Janssen submits supplemental biologics license application to US FDA seeking approval of Rybrevant (amivantamab-vmjw) plus chemotherapy for the treatment of patients with EGFR mutated non-small-cell lung cancer who progressed on or after osimertinib
20 November 2023 - This 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 announced today the submission of a supplemental biologics license application to the US FDA seeking the approval of Rybrevant (amivantamab-vmjw) in combination with chemotherapy (carboplatin and pemetrexed) for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer with EGFR exon 19 deletions or L858R substitution after disease progression on or after osimertinib mesylate.
