Johnson & Johnson said on Monday that the European Commission has granted approval for a subcutaneous version of Rybrevant (amivantamab) to be administered on every-three-week and every-four-week schedules in patients with advanced non-small cell lung cancer that harbors specific EGFR mutations.
According to the company, the newly authorized subcutaneous formulation is approved for use across the same indications for which the intravenous form of amivantamab already held authorization. The decision expands how clinicians can deliver the therapy to the same patient populations previously treated with the intravenous product.
The regulatory action allows patients to receive Rybrevant less frequently than with the intravenous regimen, with dosing intervals set at either every three weeks or every four weeks. The subcutaneous presentation therefore provides an additional administration option for physicians and patients, representing an alternative delivery method to the intravenous infusion that had been the sole option prior to this authorization.
This approval covers the European Union regulatory territory, where the European Commission's decision applies. The company statements indicate that the subcutaneous formulation aligns with the existing scope of approved intravenous indications for amivantamab, rather than changing the populations for which the drug may be used.
Beyond noting the new route of administration and the permitted dosing intervals, the announcement does not provide further operational details regarding rollout timing, clinical uptake, or comparative clinical outcomes versus the intravenous form. It also does not, in the company statements cited, address issues such as distribution, reimbursement, or the specifics of how clinicians will choose between the intravenous and subcutaneous options for individual patients.
Summary of the regulatory change:
- The European Commission has approved a subcutaneous form of Rybrevant (amivantamab) for every-three-week and every-four-week dosing in patients with advanced EGFR-mutated non-small cell lung cancer.
- The subcutaneous formulation is authorized for the same indications as the previously approved intravenous amivantamab.
- The authorization expands delivery options by adding a subcutaneous alternative to the prior intravenous-only administration.