FDA Approves Lazcluze (lazertinib) with Amivantamab for EGFR-Mutant NSCLC

Not reported in label.

LAZCLUZE, in combination with amivantamab, is indicated 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, as detected by an FDA-approved test.

The recommended dosage of LAZCLUZE is 240 mg orally once daily with or without food, given in combination with amivantamab. Continue treatment until disease progression or unacceptable toxicity. Administer LAZCLUZE any time prior to amivantamab when given on the same day. Refer to the amivantamab prescribing information for recommended amivantamab dosing information. Administer prophylactic and concomitant medications to reduce the risk of dermatologic adverse reactions. Administer anticoagulant prophylaxis to reduce the risk of venous thromboembolic events (VTE) for the first four months of treatment. For missed doses within 12 hours, take the missed dose; if more than 12 hours, skip and take next dose at scheduled time. If vomiting occurs, take next dose at regularly scheduled time. Dose reductions for adverse reactions: first reduction to 160 mg once daily, second to 80 mg once daily, third discontinue LAZCLUZE.

Trial data not available in label.

Venous Thromboembolic Events (VTE): For Grade 2 or 3, withhold LAZCLUZE and amivantamab, administer anticoagulant treatment, then resume at same dose level at discretion. For Grade 4 or recurrent Grade 2 or 3 despite therapeutic anticoagulation, withhold LAZCLUZE and permanently discontinue amivantamab; continue LAZCLUZE at same dose at discretion. Interstitial Lung Disease (ILD)/Pneumonitis: For any Grade, withhold LAZCLUZE and amivantamab if suspected; permanently discontinue if confirmed. Dermatologic adverse reactions: Prophylactic oral antibiotic (doxycycline or minocycline 100 mg twice daily) for first 12 weeks, then clindamycin 1% topical once daily to scalp for next 9 months; use non-comedogenic moisturizer; wash hands and feet with 4% chlorhexidine once daily; limit sun exposure.

LAZCLUZE in combination with amivantamab is a first-line treatment option for adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations. It is a kinase inhibitor administered orally once daily. Prophylactic anticoagulation for VTE and dermatologic adverse reaction management are required.