Alunbrig

Approved Uses

Alunbrig is used to treat adults with non-small cell lung cancer (NSCLC) that has spread to other parts of the body (metastatic). It is specifically indicated for patients whose cancer is caused by a defect in the anaplastic lymphoma kinase (ALK) gene, often referred to as ALK-positive lung cancer.

Before starting treatment, a healthcare professional must confirm the presence of the ALK-positive genetic marker using a specific diagnostic test. This medication may be prescribed in the following situations:

• As a first-line treatment for patients who have not previously received treatment for their metastatic ALK-positive NSCLC.
• For patients whose metastatic ALK-positive NSCLC has worsened while taking another medication called crizotinib, or for those who cannot tolerate crizotinib.

Targeting ALK Proteins

Alunbrig belongs to a class of medications known as tyrosine kinase inhibitors (TKIs). It is specifically designed to treat non-small cell lung cancer that is caused by a defect in a gene called anaplastic lymphoma kinase (ALK). This genetic change causes the body to produce an abnormal ALK protein that sends constant signals telling cancer cells to grow and divide.

How the Medication Works

The medication works by identifying and attaching to these abnormal ALK proteins. Once attached, it blocks the signals that the proteins send to the cancer cells. By interfering with these pathways, Alunbrig can help:

• Slow down the growth of the tumor.
• Stop the cancer from spreading to other parts of the body.
• Shrink existing tumors.

Overcoming Resistance

In some cases, cancer cells can change or mutate to become resistant to other treatments. Alunbrig is designed to be effective against several different mutations of the ALK protein, including those that may have caused other similar medications to stop working. It also has the ability to inhibit other proteins, such as ROS1, which may play a role in cancer growth.

Common Side Effects

Many people taking Alunbrig experience side effects. Common symptoms include:

• Nausea, diarrhea, or vomiting
• Fatigue or feeling weak
• Cough
• Headache
• Muscle pain
• Rash
• Constipation
• Changes in laboratory tests, such as high blood sugar or increased liver and pancreatic enzymes

Serious Side Effects

Some side effects can be severe. Seek medical care immediately if you notice:

• Lung problems: New or worsening breathing problems, cough, or fever, particularly during the first week of treatment.
• High blood pressure: Symptoms may include headaches, dizziness, or chest pain.
• Slow heart rate: Feeling faint or lightheaded.
• Vision changes: Blurred vision, double vision, or sensitivity to light.
• Muscle damage: Unexplained muscle pain, tenderness, or weakness.
• High blood sugar: Increased thirst, frequent urination, or blurred vision.

Lung Problems

Severe or life-threatening lung inflammation, known as interstitial lung disease or pneumonitis, can occur during treatment. These issues often appear within the first week of starting the medication. Symptoms such as a new or worsening cough, shortness of breath, or chest pain require immediate medical attention.

High Blood Pressure and Heart Rate

Treatment may lead to high blood pressure (hypertension) or a slow heart rate (bradycardia). Healthcare providers typically monitor blood pressure and heart rate before starting the drug and regularly throughout treatment. Dose adjustments or additional medications may be necessary to manage these conditions.

Vision Changes

Some individuals experience visual disturbances, including blurred vision, double vision, or increased sensitivity to light. Any new or worsening changes in vision should be reported to a healthcare professional.

Muscle and Organ Effects

• Muscle damage: Increased levels of creatine phosphokinase (CPK) in the blood can indicate muscle injury. Symptoms may include unexplained muscle pain, tenderness, or weakness.
• Pancreas inflammation: Elevated levels of amylase or lipase enzymes may occur, which can signal potential problems with the pancreas.
• High blood sugar: Blood glucose levels may increase during treatment (hyperglycemia). This is particularly important for individuals with diabetes or glucose intolerance, who may require more frequent monitoring.

Pregnancy and Fertility

This medication can cause harm to an unborn baby. Effective birth control is recommended for females of reproductive potential during treatment and for at least four months after the final dose. Males with female partners of reproductive potential should use effective contraception during treatment and for at least three months after the final dose. The medication may also decrease fertility in males.

Pregnancy Considerations

Alunbrig can cause fetal harm when administered to a pregnant woman. Based on its mechanism of action and findings from animal studies, this medication may cause birth defects or the loss of a pregnancy. Healthcare providers typically require a pregnancy test before starting treatment to ensure the patient is not pregnant.

Contraception

Because of the risks to a developing fetus, specific contraceptive measures are recommended:

• Females: Individuals who can become pregnant should use effective non-hormonal contraception during treatment and for at least 4 months after the final dose. Alunbrig may interact with and decrease the effectiveness of hormonal contraceptives, such as birth control pills, patches, or implants.
• Males: Men with female partners of reproductive potential should use effective contraception during treatment and for at least 3 months after the final dose.

Breastfeeding

It is not known if Alunbrig passes into human breast milk. Due to the potential for serious adverse reactions in a breastfed infant, it is advised that individuals do not breastfeed during treatment and for 1 week after the last dose.

Fertility

This medication may impair fertility in males. The long-term effects on fertility are not fully known, so individuals should discuss family planning concerns with their healthcare provider.

Dosage Forms

Alunbrig is supplied as a film-coated tablet for oral administration. It is intended to be swallowed whole and is typically taken once per day.

• Oral tablet

FDA Approval History

The U.S. Food and Drug Administration (FDA) first granted accelerated approval to Alunbrig in April 2017. This initial approval was for patients with metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who had previously been treated with crizotinib but experienced disease progression or intolerance.

In May 2020, the FDA expanded the approval to include the first-line treatment of adult patients with ALK-positive metastatic NSCLC. This allows the medication to be used as the initial therapy for patients whose cancer has spread.

Regulatory Requirements

Alunbrig is indicated only for patients whose tumors have been confirmed as ALK-positive using an FDA-approved diagnostic test. While the medication does not require a Risk Evaluation and Mitigation Strategy (REMS) program, the FDA-approved labeling includes specific warnings regarding potential serious adverse reactions.

• Interstitial Lung Disease (ILD)/Pneumonitis: Severe or life-threatening lung inflammation has been reported, particularly during the first week of treatment.
• Monitoring: The FDA requires monitoring for hypertension, bradycardia, visual changes, and elevations in muscle or pancreatic enzymes during therapy.
• Embryo-Fetal Toxicity: Based on its mechanism of action, the FDA warns that Alunbrig can cause fetal harm when administered to pregnant women.

Factors Influencing Cost

The price of Alunbrig is influenced by several factors, as it is a specialized prescription medication used for specific types of lung cancer. These factors include:

• Insurance Coverage: Most private insurance plans and Medicare provide coverage for Alunbrig, but out-of-pocket costs like copayments or coinsurance depend on the specific plan's formulary and tier structure.
• Pharmacy Selection: Alunbrig is often classified as a specialty medication. It may only be available through specific specialty pharmacies, which can impact the final cost to the patient.
• Financial Assistance: Patients may be eligible for support programs or copay assistance provided by the manufacturer to help manage the expenses associated with this treatment.

Because costs are subject to change and vary by individual circumstances, patients are encouraged to contact their insurance provider or pharmacist for the most current pricing information. Healthcare providers can also provide guidance on navigating financial assistance options.