FDA Approves New Molecular Entity Lazertinib for Lung Cancer Treatment

FDA has given approval for Janssen’s New Molecular Entity Lazertinib (Lazcluze). Approval is accorded for Lazertinib in combination with amivantamab-vmjw (Rybrevant) for treatment of non-small cell lung cancer (NSCLC). Lazertinib is a kinase inhibitor of epidermal growth factor receptor. Rybrevant plus Lazcluze is a chemotherapy free combination regimen for treatment of EGFR-mutated NSCLC.

The recommended dosage of Lazertinib is 240 mg orally once daily, administered in combination with amivantamab and dosage form is available as 80mg and 240mg tablets.

Lazertinib received its first approval in January 2021 in Korea for the treatment of patients with metastatic NSCLC. Janssen has also submitted Marketing Authorisation Application for Lazertinib in Europe with EMA (European Medicines Agency) in December 2023).

FDA Announcement

Janssen Press Release