Tecartus

Approved Indications

Tecartus is a chimeric antigen receptor (CAR) T-cell therapy. It is used to treat specific cancers of the immune system in adults, specifically:

• Mantle cell lymphoma (MCL): It is used for adults with this type of non-Hodgkin lymphoma when the cancer has returned (relapsed) or did not respond to previous treatments (refractory).
• B-cell precursor acute lymphoblastic leukemia (ALL): It is used for adults with this type of blood cancer when it has relapsed or is refractory to other therapies.

This medication is generally prescribed only after a patient has already tried other forms of treatment, such as chemotherapy or other targeted therapies, without achieving a lasting response.

The CAR T-Cell Process

Tecartus is a personalized treatment made from your own white blood cells, specifically T cells. These cells are a vital part of the immune system that normally help the body fight infections and other diseases.

The process of how Tecartus works involves several steps:

• Collection: Your T cells are collected from your blood through a process called leukapheresis.
• Modification: In a laboratory, these cells are genetically changed to include a special protein called a chimeric antigen receptor (CAR).
• Targeting: This new receptor acts like a GPS, allowing the T cells to recognize and attach to a specific protein called CD19, which is found on the surface of certain cancerous B cells.
• Elimination: Once the modified cells are infused back into your body, they multiply and seek out the cancer cells. When they bind to the CD19 protein, the T cells are activated to kill the cancer cells.

By reprogramming your own immune system, Tecartus helps the body identify and attack cancer cells that it might otherwise ignore.

Common Side Effects

Many people receiving Tecartus experience side effects. These often include:

• Fever and chills
• Fatigue or extreme tiredness
• Nausea, diarrhea, or constipation
• Headache
• Muscle or joint pain
• Cough or shortness of breath
• Swelling in the arms or legs
• Decreased appetite
• Fast heartbeat

Serious Side Effects

Some side effects can be very serious. Contact your healthcare provider immediately if you experience:

• Cytokine Release Syndrome (CRS): Symptoms include high fever, chills, difficulty breathing, dizziness, or very low blood pressure.
• Neurological Problems: This may include confusion, altered consciousness, seizures, tremors, or difficulty speaking and understanding speech.
• Severe Infections: Signs of infection such as fever, cough, or pain during urination.
• Low Blood Cell Counts: This can lead to an increased risk of bleeding, bruising, or infections.
• Hypogammaglobulinemia: A decrease in antibodies that help fight infections.

Boxed Warnings

Tecartus has boxed warnings for Cytokine Release Syndrome (CRS) and neurological toxicities. These conditions can be severe or life-threatening and require immediate medical attention.

Cytokine Release Syndrome (CRS)

CRS is a systemic inflammatory response that can occur after the infusion. Symptoms may include high fever, chills, difficulty breathing, and very low blood pressure. Healthcare providers monitor patients daily for at least seven days following the infusion at a certified healthcare facility.

Neurological Toxicities

Serious neurological problems, sometimes occurring alongside CRS, have been reported. Symptoms can include confusion, altered consciousness, seizures, loss of balance, or difficulty speaking. Because of these risks, patients are advised not to drive or operate heavy machinery for at least eight weeks after treatment.

REMS Program

Due to the risks of CRS and neurological toxicities, Tecartus is only available through a restricted program called the Tecartus REMS. This program ensures that hospitals and clinics are specially certified and have the necessary medications, such as tocilizumab, on hand to manage severe reactions.

Infections and Low Blood Counts

• Infections: Treatment can increase the risk of severe, life-threatening infections. Prophylactic antibiotics may be prescribed to help prevent certain infections.
• Cytopenias: Patients may experience prolonged periods of low blood cell counts, including white blood cells (neutropenia), red blood cells (anemia), and platelets (thrombocytopenia).
• Hypogammaglobulinemia: The therapy may lower the level of antibodies in the blood, which can increase the risk of infection and may require supplemental immunoglobulin treatment.

Other Precautions

There is a potential risk for secondary cancers or the development of new malignancies after treatment. Additionally, patients should avoid receiving live virus vaccines for a period of time before and after the infusion, as the safety of immunization during this time has not been established.

Pregnancy

There is no clinical data regarding the use of Tecartus in pregnant women. It is not known whether the medication can cause fetal harm or affect a person's ability to have children. Because this is a cellular therapy, there is a theoretical risk that the modified cells could cross the placenta and affect the developing fetus.

Before starting treatment, healthcare providers usually require a pregnancy test for individuals who can become pregnant. It is important to use effective birth control to prevent pregnancy during and after the treatment process. If you are pregnant or planning to become pregnant, you should consult with your doctor about the potential risks.

Breastfeeding

It is unknown if Tecartus is present in human breast milk or if it has any effect on a breastfed child or milk production. Due to the lack of data, the safety of breastfeeding during treatment has not been established. Patients should talk to their healthcare provider to evaluate the risks and benefits of breastfeeding while receiving this therapy.

Available Forms

Tecartus is provided as a suspension for intravenous infusion. This medication is an autologous cell-based gene therapy, which means it is manufactured using a patient's own white blood cells.

The medication is supplied in the following format:

• Suspension for infusion
• Infusion bag

Each treatment is custom-made for the individual patient and is delivered as a cryopreserved suspension intended for intravenous administration.

FDA Approval Status

Tecartus (brexucabtagene autoleucel) is a CD19-directed genetically modified autologous T cell immunotherapy. It is FDA-approved for the treatment of adult patients with:

• Relapsed or refractory mantle cell lymphoma (MCL).
• Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

Relapsed means the cancer has returned after a period of improvement, while refractory means the cancer did not respond to previous treatments.

Boxed Warning

The FDA has issued a Boxed Warning for Tecartus, which is the most serious warning required for a medication. This warning highlights the risk of:

• Cytokine Release Syndrome (CRS): A severe and potentially life-threatening systemic inflammatory response.
• Neurological Toxicities: Serious or life-threatening neurological reactions, such as confusion, seizures, or loss of consciousness.

REMS Program

Because of the risks of CRS and neurological toxicities, the FDA requires Tecartus to be administered through a restricted program called the Tecartus Risk Evaluation and Mitigation Strategy (REMS). This program ensures that the therapy is only available at certified healthcare facilities that are specially trained to monitor patients and manage severe adverse reactions.

Factors Influencing Cost

Tecartus is a specialized treatment created individually for each patient. Because of the complex process of collecting, modifying, and re-infusing a patient's own T-cells, the price of the medication itself is significant. Other factors that contribute to the total cost include:

• Hospitalization and facility fees for the infusion and recovery period.
• Pre-treatment procedures, such as lymphodepleting chemotherapy.
• Long-term monitoring for potential side effects.
• Travel and lodging expenses, as the treatment is only available at authorized specialized centers.

Insurance and Financial Support

Most private insurance plans and government programs like Medicare and Medicaid cover Tecartus when it is deemed medically necessary. However, insurance companies often require prior authorization before approving the treatment.

The manufacturer may offer support programs to help patients navigate the insurance process or provide financial assistance for those who qualify. Patients are encouraged to speak with their healthcare team or a financial counselor at the treatment center to explore available options.