EC approves lazertinib in combination with amivantamab for NSCLC patients

Combination therapy shows superior survival benefit over standard treatment

The European Commission (EC) has approved the marketing authorisation for LAZCLUZE (lazertinib) in combination with RYBREVANT (amivantamab) for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with EGFR mutations.

Janssen-Cilag International NV announced this approval, marking a significant advancement in NSCLC treatment.

The approval is based on the phase 3 MARIPOSA study, which showed that the combination therapy demonstrated superior overall survival compared to the current standard treatment, osimertinib. The study met its primary endpoint of progression-free survival, with median overall survival improvement expected to exceed one year.

“This chemotherapy-free regimen has already demonstrated significant progression-free survival improvements,” said Dr Antonio Passaro, medical oncologist at the European Institute of Oncology in Milan. “New topline data suggests it is expected to extend life by a median of one year or more, in patients with untreated EGFR-mutated NSCLC versus the current standard of care, osimertinib.”

Previously reported findings from the study showed that the combination of amivantamab and lazertinib had a manageable safety profile, with mostly grade 1 or 2 adverse events.

The most common treatment-emergent adverse events were paronychia, infusion-related reactions, and rash.

“Today’s approval marks an important moment in lung cancer care,” said Henar Hevia, Ph.D., Senior Director, EMEA Therapeutic Area Lead, Oncology. “It brings a new option to patients through a chemotherapy-free regimen and potentially offers more time with their loved ones.”

This EC decision follows a corresponding approval in December 2024 for the bispecific antibody amivantamab, in combination with lazertinib, for the same indication.