Lazcluze 80 Mg Tablet

Q: What makes Lazcluze different from other EGFR inhibitors, such as osimertinib?

Lazertinib (Lazcluze) is a newer third-generation EGFR TKI that selectively targets EGFR mutations and exhibits strong penetration into the brain. When combined with amivantamab (Rybrevant), it offers improved progression-free and overall survival compared to osimertinib alone, as shown in the MARIPOSA trial.

Q: How long can I expect to take Lazcluze?

Treatment duration depends on individual response and tolerability. In clinical trials, patients continued treatment until disease progression or unacceptable side effects occurred. Median progression-free survival with Lazcluze plus amivantamab was approximately 23.7 months.

Q: Can Lazcluze be taken with food or at any time of day?

Yes, Lazcluze 80 mg tablets can be taken once daily, with or without food. Try to take it at the same time each day for consistency. Follow your oncologist’s instructions exactly.

Q: What should I do if I miss a dose of Lazcluze?

If you miss a dose and it’s been less than 12 hours since your usual dosing time, take it as soon as possible. If more than 12 hours have passed, skip the missed dose and take your next dose at the regular time. Do not take two doses at once.

Q: What are the most important side effects to watch for while on Lazcluze?

Watch for serious signs like blood clots (leg swelling, chest pain, shortness of breath), new or worsening breathing issues (cough, fever), eye irritation or vision changes, and severe skin reactions. Promptly report any such symptoms to your healthcare provider.

Molecule: Lazertinib

Strength: 80 mg

Quantity: 60 Tablets

Form: Tablet

Packaging Type: Bottle

Manufacturer/Marketed By: Janssen Pharmaceuticals

Country of Origin: Belgium

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Overview

- Introduction
- Benefits
- Indications and Usage
- How it Works
- Dosage & Administration
- Side Effects
- Warning and Precaution
- Clinical Trial & Approvals
- FAQ

Description

Lazcluze (lazertinib) is a third-generation, brain-penetrant EGFR tyrosine kinase inhibitor (TKI) approved for first-line treatment of EGFR-mutated non–small cell lung cancer (NSCLC) in adults, used in combination with Rybrevant (amivantamab)

Benefits

Extended progression-free survival (PFS): In the MARIPOSA Phase 3 trial, Lazcluze + Rybrevant achieved median PFS of 23.7 months vs 16.6 months with osimertinib (HR 0.70; p = 0.0002)
Improved overall survival (OS): Final MARIPOSA analysis showed significant OS benefit, with projected >1 year longer OS compared to osimertinib (HR 0.75; p < .005)
Brain metastasis control: Demonstrated intracranial PFS of ~25.4 months vs 22.2 months—showing robust CNS activity
Chemotherapy-free: First multitargeted regimen without traditional chemotherapy showing superior efficacy vs standard care

Indications and Usage

For adults with locally advanced or metastatic NSCLC harboring EGFR exon 19 deletions or exon 21 L858R mutations, detected by an FDA-approved test
Used in combination with amivantamab (Rybrevant) as a multitargeted, chemotherapy-free regimen

How it Works

Lazcluze selectively inhibits mutant EGFR-driven tyrosine kinases, blocking the uncontrolled proliferation of cancer cells. Its ability to penetrate the brain helps control intracranial disease. When used with amivantamab—which targets both EGFR and MET via a bispecific antibody—it provides a dual blockade of key oncogenic pathways 

Dosage & Administration

Lazcluze 80 mg, orally once daily, with or without food
Rybrevant dosing: Weekly for first four infusions (1050 mg for <80 kg; 1400 mg for ≥ 80 kg), then every 2 weeks

Side Effects

Common (≥ 20% incidence with amivantamab):

Rash, fatigue, diarrhea, constipation, nausea, COVID-19 infection, stomatitis, bleeding events, paronychia, infusion-related reactions (Rybrevant), musculoskeletal pain, edema, decreased appetite, paresthesia, dry/itchy skin, ocular symptoms, changes in laboratory parameters 

Serious Adverse Events:

Venous thromboembolic events (VTE): Deep vein thrombosis/pulmonary embolism occurred; prophylactic anticoagulation recommended for first 4 months 
Pneumonitis or interstitial lung disease: May be fatal; monitor for new/worsening respiratory symptoms
Dermatologic toxicity: Severe rash, pruritus, dryness; sun protection and dermatologic care are advised 
Ocular issues: Corneal inflammation, visual disturbances—discontinue contact lenses until ophthalmologic evaluation

Warning and Precaution

Thrombosis risk: Implement prophylaxis for the initial 4 months
Pulmonary toxicity: Monitor for pneumonitis symptoms
Severe skin reactions: Recommend moisturizers, sun protection, dermatologic consultation
Ocular toxicity: Prompt ophthalmologic evaluation recommended for eye symptoms; suspend contact use during treatment
Infection risk: Vigilance for COVID-19 & other infections; manage per guidelines

Clinical Trial & Approvals

MARIPOSA Phase 3 trial (NCT04487080): 1,074 patients randomized to combination vs osimertinib and lazertinib monotherapy arms 
Primary endpoint (PFS): Combination reduced progression risk by 30% (HR 0.70; median 23.7 vs 16.6 months) 
Secondary endpoint (OS): Final analysis displayed significant survival benefit (HR 0.75; median OS not reached vs ~36.7 months) 
Approval milestones:
- U.S. FDA: August 19–20, 2024, for use with Rybrevant 
- European Commission: late 2024 / early 2025; South Korea: January 2021 (monotherapy approvals earlier)

FAQ

What makes Lazcluze different from other EGFR inhibitors, such as osimertinib?+

Lazertinib (Lazcluze) is a newer third-generation EGFR TKI that selectively targets EGFR mutations and exhibits strong penetration into the brain. When combined with amivantamab (Rybrevant), it offers improved progression-free and overall survival compared to osimertinib alone, as shown in the MARIPOSA trial.

How long can I expect to take Lazcluze?+

Treatment duration depends on individual response and tolerability. In clinical trials, patients continued treatment until disease progression or unacceptable side effects occurred. Median progression-free survival with Lazcluze plus amivantamab was approximately 23.7 months.

Can Lazcluze be taken with food or at any time of day?+

Yes, Lazcluze 80 mg tablets can be taken once daily, with or without food. Try to take it at the same time each day for consistency. Follow your oncologist’s instructions exactly.

What should I do if I miss a dose of Lazcluze?+

If you miss a dose and it’s been less than 12 hours since your usual dosing time, take it as soon as possible. If more than 12 hours have passed, skip the missed dose and take your next dose at the regular time. Do not take two doses at once.

What are the most important side effects to watch for while on Lazcluze?+

Watch for serious signs like blood clots (leg swelling, chest pain, shortness of breath), new or worsening breathing issues (cough, fever), eye irritation or vision changes, and severe skin reactions. Promptly report any such symptoms to your healthcare provider.