Posted by Michael Wonder on 17 Dec 2024
Update on US regulatory review of subcutaneous amivantamab
16 December 2024 - Johnson & Johnson today announced the US FDA has issued a complete response letter for the biologics license application for a fixed combination of amivantamab and recombinant human hyaluronidase for subcutaneous administration in patients with non-small cell lung cancer with epidermal growth factor receptor mutations.
The letter is related to observations as part of a standard pre-approval inspection at a manufacturing facility.
