Question 1

What is Yescarta?

Accepted Answer

Yescarta is a type of immunotherapy called chimeric antigen receptor (CAR) T-cell therapy. This treatment works by using the body's own immune system to recognize and fight certain types of cancer cells.

The therapy involves genetically modifying a patient's T cells so they can produce specific receptors on their surface. These modified cells are designed to identify and attack cancer cells that express a particular protein.

Question 2

What is Yescarta used for?

Accepted Answer

Yescarta is used to treat follicular lymphoma and large B-cell lymphoma .

Question 3

How does Yescarta work?

Accepted Answer

The CAR T-Cell Process

Yescarta works by reprogramming a patient's T cells, which are a type of white blood cell responsible for fighting infections and diseases. The process involves several steps:

Collection: T cells are removed from the patient's blood through a process called leukapheresis.

Modification: In a specialized laboratory, a new gene is inserted into these T cells. This gene instructs the cells to produce a specific protein on their surface called a chimeric antigen receptor (CAR).

Expansion: The modified T cells are grown in large numbers before being sent back to the medical facility.

Infusion: The patient receives the modified cells back into their bloodstream through an intravenous (IV) infusion.

Targeting Cancer Cells

The chimeric antigen receptor (CAR) on the modified T cells is designed to recognize and bind to another protein called CD19. This protein is found on the surface of certain types of B-cell lymphoma cells. Once the modified T cells attach to the CD19 protein, they are activated to kill the cancer cells and may continue to multiply in the body to provide ongoing defense.

Question 4

What are the active ingredients in Yescarta?

Accepted Answer

The active ingredient in Yescarta is axicabtagene ciloleucel .

Question 5

What are the side effects of Yescarta?

Accepted Answer

Common side effects of Yescarta may include:

fever

fatigue

low blood pressure

and others

Always consult with a healthcare professional about potential side effects.

Question 6

What drug class is Yescarta?

Accepted Answer

Yescarta belongs to the CAR T-cell therapy drug class.

Question 7

What is the dosage of Yescarta and how do I take it?

Accepted Answer

The Treatment Process

Yescarta is a personalized therapy created from your own T cells, a type of white blood cell. The process begins with leukapheresis, where blood is drawn to collect these cells. The cells are then sent to a manufacturing facility to be genetically modified to target cancer cells.

Preparation for Infusion

A few days before the infusion, you will receive a short course of chemotherapy to prepare your immune system. On the day of the infusion, you will be given premedications, such as acetaminophen and an antihistamine, to help reduce the risk of a reaction during the procedure.

Administration

The treatment is given as a single intravenous infusion. It must be administered at a certified healthcare facility by trained medical staff. After the infusion, you will be monitored closely for several weeks to manage any potential side effects.

Missed Doses

Since Yescarta is a one-time treatment administered by medical professionals, missing a dose is unlikely. However, if you miss an appointment for the cell collection, chemotherapy, or the infusion itself, you should contact your treatment team immediately to reschedule.

Question 8

Is Yescarta safe during pregnancy and breastfeeding?

Accepted Answer

It is not known if Yescarta can cause harm to an unborn baby, as there are no clinical studies involving pregnant women. However, because of the way Yescarta works in the body, it could potentially cause a decrease in B-cells (a type of white blood cell) in the fetus.

Key considerations for pregnancy include:

Pregnancy Testing: Healthcare providers typically require a negative pregnancy test for individuals of reproductive potential before starting the treatment process.

Contraception: Patients should discuss the use of effective birth control with their doctor to prevent pregnancy during and after treatment.

There is no information available on whether Yescarta passes into human breast milk or how it might affect a nursing infant. Because the risks are unknown, patients should discuss the benefits and risks of breastfeeding with their healthcare team while undergoing treatment.

Question 9

What forms and strengths does Yescarta come in?

Accepted Answer

Dosage Forms

Yescarta is available as a cell suspension for intravenous infusion. It is a personalized treatment created from a patient's own T cells, which are a type of white blood cell.

Administration and Packaging

It is supplied as a frozen suspension in an infusion bag.

The medication is administered as an infusion into a vein.

Each dose is prepared specifically for the individual patient.

Question 10

What is the FDA approval status of Yescarta?

Accepted Answer

FDA Approval and Indications

Yescarta (axicabtagene ciloleucel) is a genetically modified autologous T-cell immunotherapy. It was first approved by the U.S. Food and Drug Administration (FDA) in 2017. It is currently approved for use in adult patients with:

Large B-cell lymphoma (LBCL) that has not responded to first-line chemoimmunotherapy or has returned within 12 months of that treatment.

Relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma.

Relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma.

Boxed Warning and Safety Requirements

The FDA has issued a Boxed Warning for Yescarta because it can cause serious or life-threatening side effects, including:

Cytokine Release Syndrome (CRS): A severe systemic inflammatory response that can cause high fever and organ dysfunction.

Neurologic Toxicities: Serious brain-related side effects such as confusion, seizures, or altered consciousness.

Due to these risks, the FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for Yescarta. This restricted program ensures that the medication is only administered at certified healthcare facilities that are specially trained to monitor for and manage these severe reactions. These facilities must have immediate access to specific medications, such as tocilizumab, to treat cytokine release syndrome.

Question 11

What should I know about Yescarta and cost?

Accepted Answer

Factors Influencing Cost

The cost of Yescarta is high because it is a personalized gene therapy. The treatment involves collecting a patient's own T cells, genetically engineering them in a laboratory, and then infusing them back into the patient. This one-time treatment requires significant resources and specialized facilities.

Additional Treatment Costs

The total cost of care often exceeds the price of the drug itself. Additional expenses typically include:

Hospitalization for the infusion and the mandatory monitoring period afterward.

Management of potential side effects, such as cytokine release syndrome or neurological toxicities.

Travel and lodging expenses if the patient does not live near an authorized treatment center.

Insurance and Financial Assistance

Most insurance providers, including Medicare and Medicaid, offer coverage for Yescarta when it is used for FDA-approved indications. However, patients often need prior authorization before treatment begins. The manufacturer may provide financial assistance programs or support services to help patients manage out-of-pocket costs and navigate insurance requirements.

Yescarta

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