On 3 February 2025, Johnson & Johnson (J&J) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended an indication extension for its subcutaneous Rybrevant® (amivantamab):
- in combination with Lazcluze® (lazertinib) for the first-line treatment of certain adult patients with advanced non-small cell lung cancer (NSCLC); and
- as monotherapy for the treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy.
Intravenous Rybrevant® has previously been approved in Europe for both of these indications (December 2024).
In December 2024, J&J announced that 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.