Full FDA approval for Rybrevant a first-line therapy in EGFR-m NSCLC

The US Food and Drug Administration (FDA) on Friday approved Rybrevant (amivantamab-vmjw), from Janssen Biotech, a Johnson & Johnson (NYSE: JNJ) company, with carboplatin and pemetrexed for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test.

The FDA also granted traditional approval to amivantamab-vmjw for adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

The product has the potential to bring meaningful competition for UK pharma major AstraZeneca (LSE: AZN), which generated $5 billion in sales last year for its Tagrisso (osimertinib), the current standard of care.