On 19 September 2024, Johnson & Johnson (J&J) announced that it received FDA approval for Rybrevant® (amivantamab-vmjw) 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) with epidermal growth factor receptor exon 19 deletions or L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.
The approval is based on results from the Phase 3 MARIPOSA-2 (NCT04988295) study which showed that Rybrevant® plus chemotherapy reduced the risk of disease progression or death by 52 percent vs. chemotherapy alone.
In July 2024, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended an indication extension for Rybrevant® for the same indication.
Rybrevant® will be considered for PBS listing by Australia’s PBAC for the NSCLC indication at its November 2024 meeting.