J&J’s Rybrevant Combination Approved for First-Line Treatment of EGFR-Mutated Non-Small Cell Lung Cancer

FDA Approval:
The U.S. Food and Drug Administration (FDA) has approved Johnson & Johnson's Rybrevant (amivantamab-vmjw) in combination with lazertinib for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or L858R substitution mutations.

Clinical Trial Results:
The approval is based on the Phase 3 MARIPOSA study, which showed that the combination of Rybrevant and lazertinib demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared to osimertinib (Tagrisso) in patients with previously untreated EGFR-mutated NSCLC.

Competitive Landscape:
This approval introduces a new competitor to AstraZeneca's Tagrisso, which is widely used in EGFR-mutated lung cancer and is AstraZeneca's second highest-selling product.

Safety Considerations:
About 10% of patients given Rybrevant and lazertinib discontinued treatment due to side effects, compared to 3% of those on Tagrisso. The FDA requires patients to receive prophylactic anticoagulation during the first months of therapy with J&J’s regimen due to a safety signal of venous thromboembolic events.

Global Approvals:
Rybrevant has also received approval from health authorities in Europe and other markets around the world for various indications in NSCLC.