Tecvayli

Multiple Myeloma Treatment

Tecvayli is used for the treatment of relapsed or refractory multiple myeloma in adults. It is specifically intended for patients whose cancer has come back (relapsed) or did not respond to treatment (refractory) after they have already tried several other options.

This medication is typically prescribed only after a patient has received at least four prior lines of therapy. These previous treatments must include at least one drug from each of the following categories:

• Proteasome inhibitors
• Immunomodulatory agents
• Anti-CD38 monoclonal antibodies

The FDA granted accelerated approval for this use based on the drug's ability to produce a response in patients with advanced disease. Continued approval may depend on the results of ongoing clinical trials to confirm its long-term clinical benefits.

How Tecvayli Works

Tecvayli (teclistamab-cqyv) is a type of immunotherapy known as a bispecific T-cell engager. It is designed to recognize and bind to two different targets at the same time to help the immune system fight cancer.

The medication works through the following mechanism:

• Targeting Cancer Cells: One part of the antibody attaches to a protein called B-cell maturation antigen (BCMA), which is found on the surface of multiple myeloma cells.
• Engaging Immune Cells: Another part of the antibody attaches to a protein called CD3, which is found on the surface of T-cells. T-cells are a type of white blood cell responsible for attacking foreign or abnormal cells in the body.

By binding to both targets simultaneously, Tecvayli acts like a bridge that pulls the T-cells directly to the myeloma cells. This close proximity activates the T-cells, triggering them to release substances that destroy the cancer cells. This process helps the immune system identify and eliminate cancer cells that might otherwise evade the body's natural defenses.

Common Side Effects

Common side effects associated with Tecvayli treatment include:

• Fever
• Musculoskeletal pain, including back and joint pain
• Injection site reactions, such as redness, itching, or swelling where the medicine was injected
• Fatigue and general weakness
• Nausea and diarrhea
• Headache
• Upper respiratory tract infections and cough

Serious Side Effects

Tecvayli may cause serious or life-threatening side effects. Seek medical help immediately if you experience symptoms of the following:

• Cytokine Release Syndrome (CRS): Symptoms may include fever, chills, low blood pressure, and difficulty breathing.
• Neurologic toxicity: Symptoms may include confusion, headache, tremors, or difficulty with speech and writing.
• Severe infections: This includes pneumonia and other life-threatening infections.
• Low blood cell counts: Reduced levels of white blood cells, red blood cells, or platelets can increase the risk of infection, fatigue, and bleeding.
• Liver problems: Changes in liver enzyme levels may occur during treatment.

Boxed Warning: Cytokine Release Syndrome and Neurologic Toxicity

Tecvayli can cause cytokine release syndrome (CRS), which is a systemic inflammatory response that can be severe or life-threatening. Symptoms may include fever, chills, low blood pressure, and difficulty breathing. Most cases of CRS occur during the initial step-up dosing period.

Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), is also a serious risk. Symptoms can include confusion, headache, tremors, seizures, or difficulty speaking. Because of these risks, Tecvayli is only available through a restricted program called the Tecvayli REMS (Risk Evaluation and Mitigation Strategy).

Infections

Tecvayli can increase the risk of severe, life-threatening, or fatal infections, including bacterial, viral, and fungal infections. Healthcare providers monitor for signs of infection and may provide preventative treatments. Patients are often advised to report any new fever or symptoms of illness immediately.

Blood and Immune System Effects

• Neutropenia: This medication can cause a significant decrease in white blood cell counts (neutropenia), which increases the risk of infection. Blood counts are monitored regularly during treatment.
• Hypogammaglobulinemia: Tecvayli may lower the levels of antibodies (immunoglobulins) in the blood, which can further weaken the immune system.

Liver Toxicity

Treatment may cause liver damage or elevations in liver enzymes. Healthcare providers perform blood tests to monitor liver function before starting treatment and periodically thereafter.

Embryo-Fetal Toxicity

Based on its mechanism of action, Tecvayli may cause harm to an unborn baby. Individuals who can become pregnant should use effective contraception during treatment and for five months after the final dose. Breastfeeding is not recommended during treatment and for five months following the last dose.

Pregnancy

There are no adequate studies on the use of Tecvayli in pregnant women. Based on how the drug works, it may cause harm to a developing fetus. Healthcare providers usually require a pregnancy test before starting this medication to confirm you are not pregnant.

Females who are able to become pregnant should use effective birth control during treatment and for 5 months after the last dose. If you become pregnant while receiving this medication, notify your healthcare provider right away.

Breastfeeding

It is unknown if Tecvayli passes into breast milk or if it could affect a nursing child. Because of the potential for serious side effects in a breastfed infant, breastfeeding is not recommended during treatment and for 5 months after the final dose.

Dosage Forms

Tecvayli is supplied as a sterile, preservative-free solution in single-dose vials. It is intended for subcutaneous administration, which involves injecting the medication into the fatty tissue layer just beneath the skin.

• Subcutaneous Injection: The medication is administered as an injection under the skin, usually in the abdomen or thigh.

This medication is administered only by a healthcare provider in a clinical setting because of the need for monitoring during and after the injection.

FDA Approval Status

The U.S. Food and Drug Administration (FDA) granted accelerated approval to Tecvayli in October 2022. This approval was based on the drug's response rate and the duration of that response in clinical trials. Because it was approved under the accelerated pathway, continued approval for this use may depend on the results of ongoing trials that confirm its clinical benefit.

Approved Indications

Tecvayli is indicated for the treatment of adults with multiple myeloma that has returned (relapsed) or did not respond to treatment (refractory). Patients must have previously received at least four different types of therapy, including:

• A proteasome inhibitor
• An immunomodulatory agent
• An anti-CD38 monoclonal antibody

Boxed Warning and Safety Programs

The FDA has issued a Boxed Warning for Tecvayli due to the risk of two serious conditions:

• Cytokine Release Syndrome (CRS): A systemic inflammatory response that can be severe or life-threatening.
• Neurologic Toxicity: This includes Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), which can cause confusion, seizures, or other brain-related issues.

Because of these risks, Tecvayli is only available through a restricted program called the Tecvayli Risk Evaluation and Mitigation Strategy (REMS). Healthcare providers and facilities must be certified in this program to prescribe or administer the medication.

Regulatory Designations

During its development, Tecvayli received several special regulatory designations from the FDA, including Orphan Drug designation and Breakthrough Therapy designation. These designations are intended to expedite the development and review of drugs for serious or rare conditions.

Insurance and Coverage

The amount you pay for Tecvayli depends largely on your health insurance plan. Most private insurance companies, as well as Medicare and Medicaid, typically provide coverage for this medication, though they often require prior authorization from your doctor. Your specific out-of-pocket costs will be determined by your plan's deductible, copayments, or coinsurance.

Factors Affecting Price

Several factors can influence the total cost of treatment with Tecvayli:

• Treatment Phase: The dosage and frequency of injections change during the initial step-up phase and subsequent maintenance phases, which can affect the monthly cost.
• Administration Fees: Since Tecvayli is administered by a healthcare professional, you may incur additional costs for the clinic visit and the procedure to give the injection.
• Location: Costs may vary depending on whether the medication is administered in a hospital, an outpatient clinic, or a specialized infusion center.

Financial Assistance

If you are concerned about the cost of Tecvayli, several resources may be available to help:

• Manufacturer Programs: The pharmaceutical company that produces Tecvayli may offer copay cards for patients with commercial insurance or patient assistance programs for those who are uninsured or underinsured.
• Support Foundations: Non-profit organizations sometimes provide grants or financial aid to help patients with multiple myeloma cover their treatment expenses.

It is best to consult with your healthcare provider's billing office or your insurance company to get a detailed estimate of your expected costs.