Janssen-Cilag International NV, a Johnson & Johnson company,  announced the European Commission (EC) approval of RYBREVANT®▼ (amivantamab) combined with LAZCLUZE®▼ (lazertinib) as a first-line treatment for advanced non-small cell lung cancer (NSCLC) in adult patients with EGFR exon 19 deletions (ex19del) or exon 21 L858R substitution mutations.

This chemotherapy-free regimen, evaluated in the Phase 3 MARIPOSA study, demonstrated a 30% reduction in the risk of disease progression or death versus osimertinib monotherapy. The study also revealed a nine-month improvement in median duration of response (25.8 months vs. 16.8 months) for the combination therapy.

The approval underscores Johnson & Johnson commitment to addressing unmet medical needs in lung cancer, Europe's leading cause of cancer-related deaths, by offering innovative therapies tailored to genetic drivers of the disease. The decision marks significant progress for patients, potentially setting a new standard of care in EGFR-mutated NSCLC.

The safety profile was consistent with prior studies, with most adverse events being manageable. A pending EC decision on a standalone Marketing Authorisation for lazertinib follows a positive CHMP opinion.