It has been announced that the European Commission (EC) has approved an extension of marketing authorisation for a subcutaneous formulation of amivantamab in combination with lazertinib.

The combination has been authorised for both the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or exon 21 (L858R) substitution mutations, and as a monotherapy for the treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy.

“While great strides have been made in the treatment of EGFR-mutated non-small cell lung cancer, a critical need still exists for treatment approaches that are not only effective but also more convenient for patients, while optimising experience in the clinic,” said Silvia Novello, M.D., Ph.D., Professor of Medical Oncology in the Oncology Department at San Luigi Hospital in Orbassano, University of Turin, Italy. “The approval of subcutaneous amivantamab will have a meaningful impact on clinical practice, offering patients greater convenience and an improved treatment experience, without compromising on the well-established efficacy of intravenous amivantamab.”

The EC approval follows the recent presentation of final overall survival results from the Phase 3 MARIPOSA study at the 2025 European Lung Cancer Congress (ELCC).

The study showed statistically superior overall survival with intravenous (IV) amivantamab plus lazertinib versus osimertinib monotherapy in the first-line treatment of patients with advanced EGFR ex19del or L858R substitution mutations.

The EC approval for subcutaneous amivantamab is supported by positive results from the Phase 3 PALOMA-3 study (NCT05388669), which demonstrated that:

Subcutaneous amivantamab was non-inferior to intravenous (IV) amivantamab, meeting both co-primary pharmacokinetic endpoints.

Administration time for subcutaneous amivantamab was approximately five minutes, and results showed a five-fold reduction in infusion-related reactions compared to IV administration.

These findings indicate the potential for enhanced patient convenience and treatment experience, all while maintaining the proven efficacy of IV amivantamab.

Source: Janssen Cilag International NV