Johnson & Johnson submits application to the European Medicines Agency for additional subcutaneous RYBREVANT▼(amivantamab) dosing regimens to treat patients with EGFR-mutated advanced non-small cell lung cancer
May 6, 2025 – Drug Discovery, Other, Pharmaceutical – EMA, Johnson & Johnson, Johnson & Johnson Innovative Medicine, NSCLC, marketing authorisation, subcutaneous formulations
- Application supports every-three-week (Q3W) and every-four-week (Q4W) SC amivantamab dosing regimens
- Subcutaneous (SC) amivantamab offers patients greater convenience with reduced administration time from hours to minutes and lower rates of IRRs and associated symptoms compared to the intravenous (IV) formulation.
6 May 2025 — Beerse, Belgium — Janssen-Cilag International NV, a Johnson & Johnson company, today announced the submission of an application to the European Medicines Agency (EMA) to extend the RYBREVANT▼ (amivantamab) marketing authorisation for additional subcutaneous (SC) formulation dosing regimens.
The application seeks approval for the use of an every-three-week (Q3W) SC amivantamab dosing regimen in combination with carboplatin and pemetrexed, for the treatment of 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 after failure of prior therapy including an EGFR tyrosine kinase inhibitor (TKI), and for the first-line treatment of adult patients with advanced NSCLC with activating EGFR Exon 20 insertion mutations. Amivantamab is currently approved for intravenous (IV) administration in combination with carboplatin and pemetrexed for these indications.
In addition, the application intends to expand the label to also include an every-four-week (Q4W) SC amivantamab dosing regimen, in combination with LAZCLUZE®▼(lazertinib) for the first-line treatment of adult patients with advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, and as monotherapy for treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy. This follows a recent European Commission approval of an every-two-week (Q2W) SC amivantamab dosing regimen for these indications.
“Although meaningful progress has been made in the treatment of EGFR-mutated non-small cell lung cancer, significant need remains for treatments with greater convenience while maintaining therapeutic efficacy,” said Henar Hevia, Ph.D., Senior Director, EMEA Therapy Area Head, Oncology, Johnson & Johnson Innovative Medicine. “The subcutaneous formulation of amivantamab reflects our ongoing commitment to innovation, with faster administration and lower rates of infusion-related reactions than IV administration. Pending approval of these additional dosing regimens, subcutaneous amivantamab will benefit eligible patients across all currently approved intravenous amivantamab indications.”
The applications to the EMA are supported by results from the Phase 2 PALOMA-2 study (NCT05498428) and the Phase 1 PALOMA study (NCT04606381), which evaluated the feasibility of SC administration, pharmacokinetics, efficacy and safety of SC amivantamab in multiple regimens in patients with advanced or metastatic EGFR-mutated NSCLC, including the Q3W and Q4W dosing regimens.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://innovativemedicine.jnj.com/emea/. Follow us at https://www.linkedin.com/company/jnj-innovative-medicine-emea/.
