On 30 December 2024, Johnson & Johnson (J&J) announced that the European Commission has approved a Type II variation extension of indication for its Rybrevant® (amivantamab) as combination therapy with Lazcluze® (lazertinib) for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or exon 21 L858R substitution mutations.
This follows recommendation of the same indication by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in November 2024.
In December 2024, J&J announced that the FDA issued a Complete Response Letter (CRL) for its US Biologics Licence Application (BLA) for a fixed subcutaneous combination of Rybrevant® and recombinant human hyaluronidase for NSCLC with EGFR mutations.