FDA approves new indication for Rybrevant

The US Food and Drug Administration yesterday approved a new indication for Rybrevant (amivantamab-vmjw), from Johnson & Johnson (NYSE: JNJ).

Rybrevant is now authorized with carboplatin and pemetrexed for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.

This is third approval from the US regulator so far this year as J&J targets $5 billion peak sales for the EGFRxMET-targeting antibody. Last month, the FDA cleared Rybrevant with Lazcluze (lazertinib) as first line therapy for NSCLLC. However, it will need to beat AstraZeneca’s Tagrisso (osimertinib), which has become the well-established standard of care in first-line EGFR-mutant NSCLC and generated $5.8 billion sales worldwide in 2023 across several lung cancer settings.