J&J: EU approves Lazcluze for lung cancer treatment
(CercleFinance.com) - J&J announces that the European Commission has approved the marketing authorization of Lazcluze (lazertinib) in combination with Rybrevant (amivantamab) for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with specific EGFR mutations (ex19del or L858R).
This approval is based on the results of a Phase 3 study demonstrating a significant improvement in progression-free survival (PFS) and, more recently, a clinically significant improvement in overall survival (OS) compared with osimertinib.
The data show that treatment would extend median life by one year or more. These results mark a major advance for patients with EGFR-mutant NSCLC," says the company.
J&J notes that the combination's safety profile was deemed 'manageable', although adverse events such as infusion-related reactions and rashes were frequently reported.
Copyright (c) 2025 CercleFinance.com. All rights reserved.
This approval is based on the results of a Phase 3 study demonstrating a significant improvement in progression-free survival (PFS) and, more recently, a clinically significant improvement in overall survival (OS) compared with osimertinib.
The data show that treatment would extend median life by one year or more. These results mark a major advance for patients with EGFR-mutant NSCLC," says the company.
J&J notes that the combination's safety profile was deemed 'manageable', although adverse events such as infusion-related reactions and rashes were frequently reported.
Copyright (c) 2025 CercleFinance.com. All rights reserved.