Lazcluze FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 26, 2024.
FDA Approved: Yes (First approved August 20, 2024)
Brand name: Lazcluze
Generic name: lazertinib
Dosage form: Tablets
Company: Johnson & Johnson Innovative Medicine
Treatment for: Non Small Cell Lung Cancer
Lazcluze (lazertinib) is a kinase inhibitor used in combination with amivantamab for the treatment of certain patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer.
- Lazcluze is indicated in combination with Rybrevant (amivantamab) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.
- NSCLC is the most common form of lung cancer, making up to 80 to 85 percent of all cases. EGFR mutations are present in 10 to 15 percent of Western patients with NSCLC with adenocarcinoma histology, and in 40 to 50 percent of Asian patients. EGFR ex19del and EGFR L858R mutations are the most common EGFR mutations.
- Lazcluze is a third-generation, brain-penetrant EGFR tyrosine kinase inhibitor that inhibits EGFR exon 19 deletions and exon 21 L858R substitution mutations at lower concentrations than wildtype EGFR. Lazcluze is used in combination with Rybrevant, an EGFR- and MET-directed bispecific antibody that engages the immune system. The combination works as a multi-targeted, chemotherapy-free treatment for NSCLC with EGFR ex19del or L858R mutations.
- FDA approval for the Rybrevant plus Lazcluze combination was based on results of the Phase 3 MARIPOSA study, which demonstrated a median progression-free survival of 23.7 months for Rybrevant plus Lazcluze versus 16.6 months for osimertinib. The median duration of response was 25.8 months for Rybrevant plus Lazcluze versus 16.7 months for osimertinib.
- Lazcluze tablets are administered orally once daily with or without food, and given in combination with amivantamab. Prophylactic anticoagulation is recommended for the first four months of treatment.
- Warnings and precautions associated with Lazcluze include venous thromboembolic events, interstitial lung disease/pneumonitis, severe rash including acneiform dermatitis, ocular adverse reactions, and fetal harm.
- Common adverse reactions for Rybrevant plus Lazcluze inlcude rash, nail toxicity, infusion-related reaction (Rybrevant), musculoskeletal pain, edema, stomatitis, VTE, paresthesia, fatigue, diarrhea, constipation, COVID-19, hemorrhage, dry skin, decreased appetite, pruritus, nausea, and ocular toxicity.
Common Grade 3 or 4 laboratory abnormalities include decreased albumin, decreased sodium, increased ALT, decreased potassium, decreased hemoglobin, increased AST, increased GGT, and increased magnesium.
Development timeline for Lazcluze
Further information
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