Subcutaneous RYBREVANT®▼ (amivantamab) approved by European Commission for every-three-week and every-four-week dosing for patients with advanced EGFR-mutated non-small cell lung cancer

Core Insights - The European Commission has approved subcutaneous (SC) amivantamab, allowing for administration in minutes rather than hours, with efficacy and safety consistent with intravenous (IV) amivantamab [1][2][3] - SC amivantamab is now authorized for all previously approved IV indications, including every-four-week (Q4W) and every-three-week (Q3W) dosing regimens for advanced non-small cell lung cancer (NSCLC) [1][2][3][4] - The new dosing options aim to reduce administration-related reactions and improve patient convenience [1][2][3][4] Company Developments - Johnson & Johnson announced the approval of SC amivantamab, which is expected to enhance the treatment experience for patients with EGFR-mutated NSCLC [1][2][3] - The approval is part of Johnson & Johnson's commitment to improving patient care and treatment flexibility [1][2][3] Clinical Study Results - The approval is supported by Phase 2 PALOMA-2 and Phase 1 PALOMA studies, which demonstrated that SC amivantamab has a response rate and safety profile similar to IV amivantamab, but with significantly fewer administration-related reactions [1][2][3][4] - Administration time for SC amivantamab is approximately five minutes, compared to five hours for the first IV infusion [1][2][3][4] Treatment Context - Amivantamab is a bispecific antibody targeting EGFR and MET mutations, which are prevalent in NSCLC [3][4] - The approval of SC amivantamab aligns with the growing need for more efficient treatment options in the context of lung cancer, which is the leading cause of cancer-related deaths in Europe [6][7]