- The European Commission approved subcutaneous dosing regimens for RYBREVANT® in advanced EGFR-mutated NSCLC.
- The approval includes every-three-week and every-four-week dosing options.
- Subcutaneous administration reduces clinic time to five minutes compared to five hours for intravenous infusion.
- The approval is based on Phase 2 PALOMA-2 and Phase 1 PALOMA study results.
Approval Overview
The European Commission has approved new subcutaneous dosing regimens for RYBREVANT® (amivantamab) in patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC). This includes every-three-week and every-four-week dosing options, expanding its use beyond the previously approved intravenous method.
Dosing Regimens
The every-four-week regimen is approved for use with LAZCLUZE® (lazertinib) for first-line treatment of adult patients with specific EGFR mutations. The every-three-week regimen is approved in combination with carboplatin and pemetrexed for patients with advanced NSCLC after failure of prior therapy.
Clinical Benefits
Subcutaneous administration offers practical advantages, such as reduced clinic time, with administration taking approximately five minutes compared to five hours for intravenous infusion. It also results in fewer administration-related reactions, maintaining efficacy and safety consistent with the intravenous formulation.
Supporting Studies
The approval is supported by data from the Phase 2 PALOMA-2 and Phase 1 PALOMA studies, which evaluated the feasibility, pharmacokinetics, efficacy, and safety of subcutaneous amivantamab. Results showed a response rate and safety profile consistent with historical intravenous dosing, with a significantly reduced incidence of administration-related reactions.
