On 16 December 2024, Johnson & Johnson (J&J) announced that the US FDA issued a Complete Response Letter (CRL) for its US Biologics License Application (BLA) for a fixed subcutaneous combination of Rybrevant® (amivantamab-vmjw) and recombinant human hyaluronidase for non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations.
The CRL resulted from FDA inspection findings at a third-party manufacturing facility. A representative for J&J stated that the company is “… working closely with the FDA to bring SC amivantamab to patients as quickly as possible, and are confident in [its] path to resolution”.
In September this year, J&J received FDA approval for Rybrevant® in combination with standard of care chemotherapy (carboplatin and pemetrexed) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).
In November 2024, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended Rybrevant in combination with lazertinib, for first-line treatment of adult patients with advanced NSCLC. Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) will also consider this same indication at its March 2025 meeting for listing on the Pharmaceutical Benefits Scheme.