Policy & Regulation
Health Canada approves Johnson & Johnson therapy for advanced EGFR-mutated lung cancer
10 March 2025 -

Healthcare products company Johnson & Johnson (J&J) (NYSE:JNJ) announced on Monday that Health Canada has approved LAZCLUZE (lazertinib) in combination with RYBREVANT (amivantamab) as a first-line treatment for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations.

Janssen Inc, a Johnson & Johnson company, holds market authorisation in Canada.

This approval makes LAZCLUZE plus RYBREVANT the first chemotherapy-free combination regimen to show a significant improvement in progression-free survival compared to osimertinib. The treatment targets EGFR and MET, addressing key drivers of disease progression.

The decision is based on the Phase 3 MARIPOSA study, which showed the combination reduced the risk of disease progression or death by 30% versus osimertinib alone. Patients receiving LAZCLUZE plus RYBREVANT had a median progression-free survival of 23.7 months compared to 16.6 months with osimertinib.

Lung cancer remains the most common cancer diagnosis and leading cause of cancer death in Canada, with NSCLC accounting for 88% of cases. EGFR mutations are present in about one-third of NSCLC cases, and many patients do not receive second-line therapy due to disease progression.

The study also found the median duration of response was nine months longer with the combination therapy compared to osimertinib.

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