Subcutaneous amivantamab biologics license application submitted to US FDA for patients with EGFR mutated non-small-cell lung cancer

Johnson & Johnson

17 June 2024 - Application based on Phase 3 PALOMA-3 results showing five-fold reduction in infusion-related reactions with five minute administration of subcutaneous amivantamab.

Johnson & Johnson announced today the submission of a biologics license application to the US FDA for a fixed combination of amivantamab and recombinant human hyaluronidase for subcutaneous administration for all currently approved or submitted indications of intravenous Rybrevant (amivantamab-vmjw) in certain patients with non-small-cell lung cancer.

Read Johnson & Johnson press release

Michael Wonder

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Michael Wonder

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Cancer , Medicine , US , Dossier