LAZCLUZE

What it is

LAZCLUZE contains lazertinib (as mesilate monohydrate) and is available in 80 mg and 240 mg film-coated tablets.

Approved indications

— 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 exon 21 L858R substitution mutations, in combination with amivantamab.

Dosing overview

The recommended dosage of LAZCLUZE is 240 mg orally once daily in combination with amivantamab until disease progression or no longer tolerated by the patient. It is recommended to administer LAZCLUZE any time prior to amivantamab when given on the same day. Prior to the use of LAZCLUZE, the presence of the relevant EGFR mutation (exon 19 deletion or exon 21 L858R substitution) must be established. If a dose of LAZCLUZE is missed, it can be administered within 12 hours. If more than 12 hours have passed since the dose was to be given, do not administer the missed dose and administer the next dose per the usual dosing schedule.

Key safety warnings

When initiating treatment with LAZCLUZE in combination with amivantamab, it is recommended to administer anticoagulant prophylaxis to prevent venous thromboembolic (VTE) events for the first four months of treatment. Ongoing anticoagulation beyond four months is at clinician's discretion. Anticoagulants use should align with clinical guidelines, use of Vitamin K antagonists is not recommended.

Regulatory history

LAZCLUZE received approval on 2025-04-09 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 exon 21 L858R substitution mutations, in combination with amivantamab. LAZCLUZE was first listed on the ARTG on 2025-04-15 in four variants: 240 mg and 80 mg film-coated tablets in both bottle and blister pack configurations.