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J&J Submits MAA to EMA for Approval of lazertinib Combined with Rybrevant® (amivantamab) for NSCLC

Dec 21, 2023

Johnson & Johnson announced it submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) seeking approval of Rybrevant® (amivantamab) combined with lazertinib, as a first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with common epidermal growth factor receptor (EGFR) mutations including exon 19 deletions (ex19del) or exon 21 L858R (L858R) substitution mutations.