LAZCLUZE (Lazertinib) for EGFR-Mutated NSCLC: Uses, How It Works, and Key Facts

Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, affecting over 200,000 people every year in the US [1]. For a long time, 化疗 has been the main treatment, but it poses many serious side effects. 

Thanks to advancements in modern medicine, we now have targeted therapies, which have transformed the treatment outcomes for many NSCLC patients. One of the newest targeted therapies is LAZCLUZE (lazertinib). When used together with amivantamab, it offers a powerful treatment option for newly diagnosed patients and improves progression-free survival compared with osimertinib.

If you are researching LAZCLUZE, you may be wondering what it is, how it works, and what the side effects are. In this article, we’ll explore everything you need to know about this medication.

What Is LAZCLUZE?

LAZCLUZE (lazertinib) is an FDA-approved medicine that is used in combination with amivantamab as a first-line treatment for adults with non-small cell lung cancer (NSCLC) that carries specific EGFR gene mutations. The FDA first approved this medicine on August 19, 2024 [3]. This approval was based on extensive clinical data that showed that LAZCLUZE outperformed osimertinib (the previous standard of care) [2].

LAZCLUZE belongs to a group of drugs known as kinase inhibitors. These drugs work by blocking the abnormal signals that help cancer cells grow and spread. LAZCLUZE comes in tablet form. The drug should be taken once daily with or without food. 

它用于治疗什么？

LAZCLUZE (lazertinib) is used in combination with amivantamab to treat patients with non-small cell lung cancer (NSCLC) that can not be removed surgically or has spread to other parts of the body (metastatic). The NSCLC must have one of the following mutations on the epidermal growth factor receptor (EGFR) gene [2]:

• Exon 19 deletions
• Exon 21 L858R substitution

Before starting the treatment with LAZCLUZE, you must conduct an FDA-approved test to confirm that you have the above-mentioned mutations. 

How Does LAZCLUZE Work?

There is a gene in your body called epidermal growth factor receptor (EGFR), which is responsible for cell growth and multiplication. Normally, these genes would turn on and off when needed to keep cell growth balanced. 

But, in many cases of non-small cell lung cancer (NSCLC), changes (mutations) occur in the EGFR gene. These mutations cause the gene to stay switched on and continuously signal the cancer cells to grow. As a result, cells multiply uncontrollably and form tumors.

LAZCLUZE attaches to the abnormal EGFR receptors inside the cancer cells and blocks the abnormal growth signals. As a result, the growth of the cancer cells slows down [2].

LAZCLUZE is mainly used together with amivantamab. While LAZCLUZE blocks EGFR activity inside the cell, amivantamab targets EGFR and MET on the outside of the cell. If you take them together, they will attack the cancer through multiple pathways. This makes the treatment more effective.

副作用

Like any other medicine, LAZCLUZE can cause some side effects. While some of these side effects are mild and temporary, others are severe and may require immediate medical attention. Here are some of the side effects [2][4]:

常见副作用

• 皮疹
• Nail toxicity
• 肿胀
• 疲劳
• 腹泻
• 皮肤干燥
• Pain in the bones, muscles, joints, or nerves
• 恶心
• 瘙痒

These side effects are usually mild and go away on their own within a few days. However, if these symptoms do not go away or worsen, contact your doctor.

严重的副作用

Serious side effects are rare but can happen. Here are some serious side effects:

血栓： LAZCLUZE can cause blood clots in your legs or lungs, which can be fatal. To prevent this, your doctor will give you anticoagulation medicines for the first 4 months of your treatment.

严重过敏反应： You may experience allergic reactions while taking LAZCLUZE, which can be severe. Symptoms of serious allergic reactions include fever, increased heart rate, trouble breathing, hives, and swelling of your face, lips, and mouth. 

Lung Problems: This medication can cause serious lung problems, which can be fatal. Symptoms include cough, trouble breathing, and fever. Contact your doctor right away if you experience these symptoms.

Skin Problems: You may experience severe skin problems while taking LAZCLUZE. Symptoms include itching, severe rash, skin redness, and dry skin. It is recommended that you limit your sun exposure during treatment and for 2 months after treatment. Protective clothing and sunscreen can help.

Please note that this is not a complete list of all possible side effects. Contact your doctor immediately if you experience any severe side effects.

Dosing Information of LAZCLUZE

The recommended dose of LAZCLUZE is 240 mg, taken once daily [2]. You can take it with or without food, and it is used together with amivantamab. Your doctor will have you continue taking this medicine until your disease progresses or if there are side effects that are too difficult to manage. If you are taking both medicines on the same day, take LAZCLUZE before the amivantamab infusion. In addition, your doctor will give you anticoagulant (blood-thinning) medicines for the first 4 months of your treatment to prevent blood clots.

成本

LAZCLUZE is available in 80 mg and 240 mg tablet form. A pack of 30 tablets (240 mg) costs around $18,350 [5]. However, the actual cost varies depending on your insurance plan, location, and the pharmacy you visit. 

常见问题解答

What are the clinical benefits of LAZCLUZE?

A large clinical study involving 1,074 patients was conducted to determine the clinical benefits of LAZCLUZE. Patients were given either LAZCLUZE alone, LAZCLUZE plus amivantamab, or osimertinib alone. 

The results showed that patients who received LAZCLUZE plus amivantamab lived for 23.7 months without their condition worsening. In contrast, those who received osimertinib alone went 16.6 months before their condition progressed [2].

Can I use LAZCLUZE during pregnancy or breastfeeding?

No. You should not use LAZCLUZE during pregnancy or breastfeeding because it can harm your unborn baby. You should also avoid breastfeeding for at least 3 weeks after your final dose.

How long do I need to take LAZCLUZE?

You will continue taking this medication until your disease worsens or you experience side effects that are extremely hard to manage.