Johnson & Johnson submits application for subcutaneous Rybrevan dosing

Company seeks approval for new schedules to improve patient convenience

Janssen-Cilag International NV, a Johnson & Johnson company, has submitted an application to the European Medicines Agency (EMA) to extend the marketing authorisation for RYBREVANT (amivantamab) with additional subcutaneous dosing regimens.

The application includes an every-three-week (Q3W) amivantamab regimen in combination with carboplatin and pemetrexed.

This would be for adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations following failure of prior therapy including an EGFR tyrosine kinase inhibitor (TKI). It would also be used for first-line treatment of NSCLC with EGFR exon 20 insertion mutations.

Additionally, Janssen is seeking approval for an every-four-week (Q4W) amivantamab dosing regimen. This would be combined with Lazcluze (lazertinib) for first-line treatment of advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations. It would also be used as monotherapy following failure of platinum-based therapy.

The move follows recent European Commission approval of an every-two-week (Q2W) amivantamab dosing regimen for these indications.

Henar Hevia, PhD, Senior Director, EMEA Therapy Area Head, Oncology, Johnson & Johnson Innovative Medicine, said: “The subcutaneous formulation of amivantamab reflects our ongoing commitment to innovation, with faster administration and lower rates of infusion-related reactions than IV administration.”

The EMA applications are supported by results from phase 2 PALOMA-2 and phase 1 PALOMA studies, which evaluated feasibility, pharmacokinetics, efficacy and safety of subcutaneous amivantamab.