Johnson & Johnson — Lazcluze EMA EPAR public assessment report (EMEA/H/C/006074, 2025)
Johnson & Johnson · 2025 · EMA EPAR public assessment report · company profile →
Report summary
The EMA assessed Lazcluze (lazertinib) in combination with amivantamab for first-line treatment of advanced EGFR-mutated NSCLC. The CHMP issued a positive opinion for marketing authorization, despite not granting accelerated assessment. The report details the product's quality, manufacturing, and extensive non-clinical and clinical development. Lazertinib, a third-generation EGFR TKI, demonstrated potent anti-tumor activity and favorable pharmacokinetics. The pivotal MARIPOSA Phase 3 trial showed the combination therapy significantly improved progression-free survival (23.72 vs 16.59 months for osimertinib) and a favorable trend in overall survival. While common adverse events included rash and paronychia, venous thromboembolism (VTE) was identified as a significant, but manageable, risk. The overall benefit-risk balance was deemed positive.
Key findings — cited to the page
| Grade 3+ Paronychia incidence in Amivantamab + Lazertinib (MARIPOSA) | 46 | MARIPOSA · p.120 |
| Grade 3+ Paronychia incidence in Osimertinib | 2 | MARIPOSA · p.120 |
| Grade 3 or higher AEs in Amivantamab | 158 | · p.117 |
| Grade 3+ Rash incidence in Amivantamab | 5 | · p.120 |
| Grade 3+ Rash incidence in Lazertinib | 7 | · p.120 |
| Grade 3+ Rash incidence in Osimertinib | 3 | MARIPOSA · p.120 |
| Grade 3 or higher AEs in Amivantamab + Lazertinib (MARIPOSA) | 316 | MARIPOSA · p.117 |
| Grade 3+ Pneumonia incidence in Lazertinib | 19 | · p.120 |
| Grade 3 or higher AEs in Lazertinib | 233 | · p.117 |
| Grade 3 or higher AEs in Osimertinib | 183 | MARIPOSA · p.117 |
| Grade 3+ Rash incidence in Amivantamab + Lazertinib (MARIPOSA) | 65 | MARIPOSA · p.120 |
| Grade 3+ Paronychia incidence in Lazertinib | 4 | · p.120 |
Source: Johnson & Johnson ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →