Posted by Michael Wonder on 10 Feb 2024
Janssen submits type II extension of indication application to the EMA seeking approval of Rybrevant (amivantamab), in combination with lazertinib, for first-line treatment of patients with EGFR mutated non-small-cell lung cancer
8 February 2024 - The submission is supported by data from the Phase 3 MARIPOSA study, showing statistically significant and clinically meaningful improvement in progression-free survival in patients with EGFR-mutated advanced NSCLC treated with amivantamab plus lazertinib versus osimertinib.
Janssen today announced the submission of a type II extension of indication application to the EMA seeking approval of Rybrevant (amivantamab), in combination with lazertinib, for the first-line treatment of adult patients with advanced non-small cell lung cancer with common epidermal growth factor receptor exon 19 deletions or exon 21 L858R substitution mutations.
