Lung cancer subcutaneous bispecific antibody FDA approval with convenient administration option
RegulatoryBusiness Wire

Johnson & Johnson Receives FDA Approval for Subcutaneous Rybrevant in Lung Cancer

J&J announces FDA approval of subcutaneous amivantamab (Rybrevant SC) for EGFR-mutated non-small cell lung cancer, offering a more convenient administration option.

Johnson & Johnson today announced that the FDA has approved a subcutaneous formulation of amivantamab (Rybrevant SC) for the treatment of EGFR-mutated non-small cell lung cancer. The subcutaneous formulation reduces administration time from approximately 5 hours for IV infusion to approximately 5 minutes. In the Phase 3 PALOMA-3 trial, subcutaneous amivantamab demonstrated non-inferiority to IV amivantamab on pharmacokinetic endpoints. This approval provides patients and healthcare providers with a more convenient administration option for amivantamab.

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