Yescarta (axicabtagene ciloleucel)

What is Yescarta?

Yescarta is a brand-name prescription medication. It’s FDA-approved for use in adults with relapsed* or refractory* large B-cell lymphoma, which is a type of non-Hodgkin lymphoma.

Specifically, Yescarta is approved to treat:

• diffuse large B-cell lymphoma (DLBCL)
• primary mediastinal large B-cell lymphoma
• high grade B-cell lymphoma
• DLBCL from follicular lymphoma

Yescarta should be only be used if you’ve already had at least two systemic therapies for your B-cell lymphoma. Systemic therapies are treatments that affect your entire body.

Yescarta can only be given by a healthcare professional in a REMS-certified facility. REMS (Risk Evaluation and Mitigation Strategies) is a program created by the Food and Drug Administration (FDA). It helps make sure that certain drugs are used safely and provided only by specially trained healthcare professionals.

* “Relapsed” means the cancer came back after past treatment. “Refractory” means the cancer hasn’t gotten better with other treatments.

Drug details

Yescarta is a type of gene therapy called chimeric antigen receptor T-cell (CAR T-cell) therapy. T cells (a type of immune system cell) are collected from your blood and modified in a laboratory. The modified cells are then infused back into your blood.

Yescarta is given as an intravenous (IV) infusion, which is an injection into your vein over a period of time. Yescarta contains the active drug ingredient axicabtagene ciloleucel.

After your infusion, you’ll need to stay at the healthcare facility for at least 7 days. During this time, your doctor will monitor you for any potentially dangerous side effects. (For information on side effects, see the “Yescarta side effects” section below.)

FDA approval

Yescarta was first approved by the FDA in 2017 for use in adults with relapsed or refractory large B-cell lymphoma, including:

• diffuse large B-cell lymphoma (DLBCL)
• primary mediastinal large B-cell lymphoma
• high grade B-cell lymphoma
• DLBCL from follicular lymphoma

Effectiveness

For information on the effectiveness of Yescarta, see the “Yescarta uses” section below.

Yescarta generic or biosimilar

Yescarta is a type of biologic drug called gene therapy. Yescarta is available only as a brand-name medication. It doesn’t come in a biosimilar form.

A biologic drug is made from living cells, while other drugs are made from chemicals. Gene therapies are made by taking a person’s blood and modifying it to make the drug.

Drugs made from chemicals can have generics, which are exact copies of the active drug in the brand-name medication. Biologics, on the other hand, can’t be copied exactly. Therefore, instead of a generic, biologics have biosimilars. Biosimilars are “similar” to the parent drug, and they’re considered to be just as effective and safe.

Like generics, biosimilars are often less expensive compared with brand-name medications.

Yescarta contains the active drug axicabtagene ciloleucel.

Yescarta vs. Kymriah

You may wonder how Yescarta compares with other medications that are prescribed for similar uses. Here we look at how Yescarta and Kymriah are alike and different.

Ingredients

Yescarta contains the active drug axicabtagene ciloleucel. Kymriah contains the active drug tisagenlecleucel.

Yescarta and Kymriah are both a type of gene therapy called chimeric antigen receptor T-cell (CAR T-cell) therapy. With this type of treatment, your T cells (a type of immune system cell) are collected from your blood and modified in a laboratory. The modified cells are then infused back into your blood.

Kymriah is the only true alternative to Yescarta. This is because it’s the only other CAR T-cell therapy drug that treats some of the same conditions as Yescarta.

Uses

Below are conditions that the Food and Drug Administration (FDA) has approved Yescarta and Kymriah to treat.

• Both Yescarta and Kymriah are FDA-approved to treat:
  • relapsed* or refractory* large B-cell lymphoma (which has been treated with at least two systemic therapies^†) in adults, including
    – diffuse large B-cell lymphoma (DLBCL),
    – high grade B-cell lymphoma
    – DLBCL from follicular lymphoma
• Yescarta is also FDA-approved to treat:
  • primary mediastinal large B-cell lymphoma (another type of B-cell lymphoma)
• Kymriah is also FDA-approved to treat:
  • relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) in children and young adults (up to age 25 years)

* “Relapsed” means the cancer came back after past treatment. “Refractory” means the cancer hasn’t gotten better with other treatments.
† Systemic therapies are treatments that affect your entire body.

Drug forms and administration

As described above, both Yescarta and Kymriah are made using your body’s own cells. Both drugs are given as an intravenous (IV) infusion, which is an injection into your vein over a period of time. Yescarta and Kymriah infusions typically last less than 30 minutes.

Both Yescarta and Kymriah are only prescribed and administered at REMS-certified healthcare facilities. This is due to the risk of cytokine release syndrome (CRS) and neurotoxicities (problems affecting the brain or nervous system).

Side effects and risks

Yescarta and Kymriah have some similar side effects and other that vary. Below are examples of these side effects.

Mild side effects

These lists contain up to 10 of the most common mild side effects that can occur with each drug, or with both Yescarta and Kymriah (when taken individually).

• Can occur with Yescarta:
  • chills
• Can occur with Kymriah:
  • minor infections
• Can occur with both Yescarta and Kymriah:
  • edema (bloating or swelling)
  • cough
  • decreased appetite
  • diarrhea
  • fast heart rate and other changes to your heart rhythm
  • fatigue (lack of energy)
  • fever
  • hypotension (low blood pressure)
  • nausea and vomiting

Serious side effects

This list contains examples of serious side effects that can occur with both Yescarta and Kymriah (when taken individually):

• allergic reaction
• low blood cell counts (such as anemia) lasting for more than a few weeks after treatment
• low counts of B cells or immunoglobulins (antibodies made by white blood cells)
• serious infections
• cytokine release syndrome (CRS)*
• neurotoxicities* (problems affecting the brain or nervous system)

* Yescarta and Kymriah both have a boxed warning for these side effects. For more information, see the “Neurotoxicities” and “Cytokine release syndrome (CRS)” sections in “Side effect details” below.

Effectiveness

These drugs haven’t been directly compared in clinical studies. However, studies have found both Yescarta and Kymriah to be effective for treating relapsed or refractory large B-cell lymphoma in adults.

Costs

To compare prices for Yescarta and Kymriah, talk with your doctor, pharmacist, or insurance company.

The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Yescarta and Kymriah are both brand-name gene therapies. Gene therapies are made specifically from taking a person’s blood and modifying it into the drug. There are currently no biosimilar forms of either drug.

Biosimilars are drugs that are based on biologic drugs, which are made from parts of living organisms. Biosimilars usually cost less than the biologic medications they’re based on.

Alternatives to Yescarta

Other drugs are available that can treat relapsed* or refractory* large B-cell lymphoma. Some may be a better fit for you than others. If you’re interested in finding an alternative to Yescarta, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

* “Relapsed” means the cancer came back after past treatment. “Refractory” means the cancer hasn’t gotten better with other treatments.

Alternatives for large B-cell lymphoma

Examples of other drugs that may be used to treat relapsed or refractory large B-cell lymphoma include:

• chemotherapy drugs, such as:
  • bendamustine (Bendeka, Treanda)
  • carboplatin
  • cisplatin
  • etoposide
  • gemcitabine
• polatuzumab vedotin-piiq (Polivy)
• rituximab (Rituxan)
• selinexor (Xpovio)
• tisagenlecleucel (Kymriah)

Yescarta uses

The Food and Drug Administration (FDA) approves prescription drugs such as Yescarta to treat certain conditions.

Yescarta for large B-cell lymphoma

Yescarta is FDA-approved for use in adults with relapsed* or refractory* large B-cell lymphoma, which is a type of non-Hodgkin lymphoma. Specifically, Yescarta is approved to treat:

• diffuse large B-cell lymphoma (DLBCL)
• primary mediastinal large B-cell lymphoma
• high grade B-cell lymphoma
• DLBCL from follicular lymphoma

Yescarta should be only be used if you’ve already had at least two systemic therapies for your B-cell lymphoma. (Systemic therapies are treatments that affect your entire body.) Also, Yescarta shouldn’t be used to treat primary central nervous system (CNS) lymphoma (lymphoma that first forms in your CNS).

About lymphoma

Lymphoma is cancer that affects your lymphatic system. Non-Hodgkin lymphoma is the most common type of lymphoma. It usually develops in B and T cells, which are immune system cells.

The lymphatic system is part of your immune system, which fights off disease. The lymphatic system consists of vessels that transport a substance called lymph throughout your body. Lymph is a fluid that contains white blood cells and helps carry bacteria out of your body tissues.

* “Relapsed” means the cancer came back after past treatment. “Refractory” means the cancer hasn’t gotten better with other treatments.

Effectiveness for large B-cell lymphoma

A clinical study showed that Yescarta is effective for treating large B-cell lymphoma.

Researchers looked at adults with relapsed or refractory large B-cell lymphoma. These adults had all received a stem cell transplant in the past. Everyone in the study was treated with chemotherapy (cyclophosphamide and fludarabine) followed by Yescarta. A placebo (a treatment with no active drug) wasn’t used.

At the end of the study, the researchers measured the success rate of Yescarta. To do this, they used a measurement called the objective response rate (ORR). ORR measures the percentage of people whose cancer shrunk or disappeared.

The researchers found that Yescarta’s ORR in the study was 72%. Specifically:

• 51% of people treated with Yescarta experienced complete remission. Complete remission is when tests show no cancer cells in your blood, or all your tumors (swollen lymph nodes) are gone.
• 21% of people had partial remission. Partial remission means the size of your tumors are reduced by 50%.

Yescarta and children

Yescarta isn’t approved for use in children. The drug hasn’t been studied in children, so it isn’t known if Yescarta is safe or effective for this age group.

Yescarta side effects

Yescarta can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Yescarta. These lists don’t include all possible side effects.

For more information on the possible side effects of Yescarta, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA of a side effect you’ve had with Yescarta, you can do so through MedWatch.

Mild side effects

Mild side effects of Yescarta can include:*

• edema (bloating or swelling)
• chills
• cough
• constipation
• decreased appetite
• diarrhea
• fast heart rate and other changes to your heart rhythm
• fatigue (lack of energy)
• hypotension (low blood pressure)
• low oxygen levels in your tissues
• minor infections
• nausea and vomiting
• fever^†

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Yescarta. To learn about other mild side effects, talk with your doctor or pharmacist, or view Yescarta’s Medication Guide.
† For more information on this side effect, see “Side effect details” below.

Serious side effects

Serious side effects from Yescarta can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects, explained in more detail below in “Side effect details,” include:

• allergic reaction
• low blood cell counts (such as anemia) lasting for more than a few weeks after treatment
• low counts of B cells or immunoglobulins (antibodies made by white blood cells)
• serious infections
• cytokine release syndrome (CRS)*
• neurotoxicities* (problems affecting the brain or nervous system)

* Yescarta has a boxed warning for this side effect. For more information, see “Side effect details” below.

Side effect details

You may wonder how often certain side effects occur with this drug. Here’s some detail on certain side effects this drug may cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Yescarta. It’s not known how often this occurred in clinical trials. Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing (warmth and redness in your skin)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling of your tongue, mouth, or throat
• trouble breathing

Call your doctor right away if you have a severe allergic reaction to Yescarta. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Neurotoxicities

Some people taking Yescarta have experienced neurotoxicities (problems affecting the brain or nervous system). In rare cases, these problems have been life threatening or fatal.Yescarta has a boxed warning for neurotoxicities. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).

In a clinical study, 87% of people who took Yescarta had a neurotoxicity. And 31% of people taking the drug had a serious neurotoxicity. Yescarta wasn’t compared with a placebo or other drugs in this study.

Of the people in the study who received Yescarta and had neurotoxicities, at least 50% of those neurotoxicities started within 4 days after the infusion. The neurotoxicities lasted for 17 days for at least half of the people who had them.

The most common neurotoxicities reported by people taking Yescarta in clinical studies included:

• anxiety
• delirium
• encephalopathy (changes in brain function or structure)
• insomnia (trouble sleeping)
• aphasia (trouble speaking or understanding what others are saying)
• dizziness
• headache
• tremor

Monitoring for neurotoxicities

Your doctor will need to monitor you for neurotoxicities after your treatment. For this reason, you’ll need to stay at the infusion facility for at least 7 days after getting your Yescarta dose. Your doctor will also want to examine you 4 weeks after your dose to make sure no neurotoxicities have occurred since you left the facility.

If you think you’re developing symptoms of neurotoxicity, call your doctor right away. Depending on how severe your problem is, they may use medications to treat this side effect. They may also want to admit you to a hospital for monitoring and to determine if anything other than Yescarta could be causing your symptoms.

Cytokine release syndrome (CRS)

Cytokine release syndrome (CRS) happens when your immune system responds too aggressively to Yescarta. The drug has a boxed warning for CRS. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).

Cytokines are proteins that help cells in your body communicate with one another. Your immune system uses cytokines to help fight infection. Yescarta works by stimulating your immune system. There’s a chance your immune system could overrespond to the medication, resulting in CRS.

CRS is a potentially very serious condition that leads to severe inflammation throughout the body and possible organ failure. CRS should be treated with tocilizumab used alone or with corticosteroids.

Symptoms of CRS may vary depending on how serious your condition is and which organs are affected. However, common symptoms can include body aches, headache, decreased appetite, diarrhea, and tiredness.

In a clinical study, 94% of people who took Yescarta reported CRS. And 13% of people taking the drug had serious CRS. Yescarta wasn’t compared with a placebo or other drugs in this study.

At least 50% of people who received Yescarta and had CRS began having symptoms 2 days after the infusion. CRS symptoms lasted for 7 days in at least half of the people who had symptoms.

Monitoring for CRS

Your doctor will need to monitor you for CRS after your treatment. For this reason, you’ll need to stay at the infusion facility for at least 7 days after getting your Yescarta dose. During this time, your doctor will monitor you for symptoms of CRS.

Your doctor will make sure the drug tocilizumab, which is approved for treating CRS, is available before you get your Yescarta dose. If you do develop CRS, they may also use other drugs, such as corticosteroids or intravenous (IV) fluids, depending on your symptoms.

Your doctor will continue to closely monitor you for 4 weeks after your infusion to be sure you don’t develop CRS. If you develop symptoms of CRS, call your doctor right away. However, call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious infections

Yescarta can increase your risk for serious infections. In one clinical study, 38% of people who took Yescarta developed an infection. And 23% of people developed an infection that was considered serious. Yescarta wasn’t compared with a placebo or other drugs in this study.

If you have an active infection, your doctor may wait until it’s gone before administering your Yescarta dose. This depends on how serious the infection is.

Low blood cell counts lasting for more than a few weeks

While taking Yescarta, some people may experience a decrease in certain blood cell counts that last for a few weeks after treatment.

In a clinical study, the following blood disorders were still active 30 days after the Yescarta dose was received:

• Anemia (low levels of red blood cells). Severe anemia occurred in 3% of people who received chemotherapy followed by Yescarta.
• Neutropenia (low levels of a certain type of white blood cell). Severe neutropenia occurred in 15% of people who received chemotherapy followed by Yescarta.
• Thrombocytopenia (low levels of platelets, a type of blood cell). Severe thrombocytopenia occurred in 18% of people who received chemotherapy followed by Yescarta.

Yescarta wasn’t compared with a placebo or other drugs in this study.

Monitoring blood cell counts

You’ll need to stay at the infusion facility for at least 7 days after getting your Yescarta dose. While you’re there, your doctor will monitor your blood tests to watch for any abnormal results. They’ll continue to monitor your blood tests after you leave the facility.

Low counts of B cells or immunoglobulins (antibodies made by white blood cells)

While taking Yescarta, some people may have reduced levels of B cells and antibodies called immunoglobulins. Antibodies are proteins created by your immune system that help your body fight infections, such as influenza (the flu).

In a clinical study, 15% of people who were treated with Yescarta has decreased levels of immunoglobulins. Yescarta wasn’t compared with a placebo (a treatment with no active drug) or other drugs in this study.

Yescarta could make your immune system less able to fight infections. Therefore, if you have an active infection, you may need to wait until it’s gone before you can get your Yescarta dose. This depends on how serious the infection is.

Because of how Yescarta may affect your immune system, you should avoid getting live vaccines for a period of time before and after your Yescarta infusion. (Live vaccines contain weakened forms of viruses or bacteria.) See “Yescarta and live vaccines” in the “Yescarta interactions” section below to learn more.

Monitoring blood cell counts

You’ll need to stay at the infusion facility for at least 7 days after getting your Yescarta dose. While you’re there, your doctor will monitor your blood tests to watch for any abnormal results. They’ll continue to monitor your blood tests after you leave the facility.

Fever

Fever is a very common side effect of Yescarta. In a clinical study, 86% of people who were treated with chemotherapy followed by Yescarta developed a fever.

Fever can also be a symptom of a more serious side effect of the drug, such as:

• Cytokine release syndrome (CRS). See the section on CRS above to learn more.
• Febrile neutropenia, which occurred in 36% of people who took Yescarta.

Febrile neutropenia is a life threatening medical emergency. In rare cases, CRS can also be life threatening. For these reasons, if you develop a fever after being treated with Yescarta, call your doctor right away. They can help determine the cause of your fever and the best treatment for you.

However, call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Secondary cancers

Being treated with Yescarta and chemotherapy may increase the risk of developing other cancers. However, it’s not known for sure if the drug causes this side effect.

Secondary cancers weren’t reported in clinical studies of Yescarta. However, this is a known side effect of cyclophosphamide, which is one of the chemotherapy drugs you’ll receive before getting your Yescarta infusion.

Yescarta was approved based on data from early phase trials. This means the manufacturer is still collecting information on possible side effects of the drug. If you develop a secondary cancer after being treated with Yescarta, you can report it to the manufacturer at 844-454-KITE (5483).

If you have questions about your risks for developing other cancers while taking Yescarta, talk with your doctor.

Yescarta dosage

The following information describes dosages that are commonly used or recommended.

Drug forms

Yescarta is given as an intravenous (IV) infusion, which is an injection into your vein over a period of time. Yescarta infusions typically takes less than 30 minutes.

Yescarta is a type of gene therapy called CAR T-cell therapy. With this type of treatment, your T cells (a type of immune system cell) are collected from your blood and modified in a laboratory. The modified cells are then infused back into your blood.

Dosage for large B-cell lymphoma

Your doctor will determine what your Yescarta dose should be, based on your body weight in kilograms (kg). If you have questions about what your specific dose will be, talk with your doctor.

Dosage questions

Below are answers to some questions you may have about receiving your Yescarta dose.

What if I miss a dose?

It’s important to keep your appointment for your Yescarta infusion. If you miss your appointment, call your doctor’s office right away to reschedule.

To help make sure you don’t miss your appointment, try setting a reminder on your phone.

Will I need to use this drug long term?

No, Yescarta isn’t meant to be used as a long-term treatment. Yescarta is approved as a one-time infusion only.

Yescarta use with other drugs

Before you receive your Yescarta infusion, you’ll need to be treated with chemotherapy* first. Specifically, you’ll receive lymphodepleting chemotherapy. This is chemotherapy that helps prepare your body for your Yescarta infusion. It also helps Yescarta to be more effective.

The chemotherapy drugs you’ll receive are cyclophosphamide and fludarabine. These are given 5, 4, and 3 days before your Yescarta infusion, for a total of three chemotherapy treatments. The chemotherapy drugs are given by intravenous (IV) injection, which is an injection into a vein.

On the day of your Yescarta infusion, you’ll also be given medications about an hour before your infusion. These drugs are called premedications, and they usually include acetaminophen (Tylenol) and diphenhydramine (Benadryl). Premedications help reduce your risk for side effects from Yescarta.

If you have questions about other medications you may need to take with Yescarta, talk with your doctor or pharmacist.

* Chemotherapy drugs are medications that affect many different types of rapidly growing cells in the body, including cancer cells.

Yescarta and alcohol

There isn’t a known interaction between Yescarta and alcohol. However, certain side effects of Yescarta can be made worse by drinking alcohol. Examples of these side effects include diarrhea and headache.

In addition, the American Cancer Society recommends that some people avoid consuming alcohol while being treated for cancer. This is because it’s thought that drinking alcohol could worsen some side effects of certain cancer treatments.

If you drink alcohol, talk with your doctor about how much, if any, is safe for you to drink during your Yescarta treatment.

Yescarta interactions

There are no known interactions between Yescarta and any other medications. The drug is also not known to interact with any herbs, supplements, or foods. If you have questions about any potential interactions with Yescarta, talk with your doctor.

However, Yescarta may interact with live vaccines.

Yescarta and live vaccines

You should avoid getting live vaccines for a period of time before and after receiving Yescarta. This is because the drug hasn’t been studied with live vaccines, so it’s not known if they may interact.

Before receiving Yescarta, you’ll need chemotherapy. You should avoid getting live vaccines at least 6 weeks before starting this chemotherapy. And you shouldn’t get live vaccines until your immune system returns to normal after receiving Yescarta. Your doctor will tell you how long you’ll need to wait after your infusion before you can get live vaccines.

About live vaccines

Live vaccines contain weakened forms of viruses or bacteria, but they usually don’t cause infections in people with healthy immune systems. However, live vaccines could cause infections in people with cancer or those whose immune systems are weakened by chemotherapy. Examples of live vaccines include:

• chickenpox
• yellow fever
• tuberculosis (TB)
• measles, mumps, and rubella (MMR)
• nasal flu spray (FluMist)

Talk with your doctor about whether you’re up to date on all recommended vaccines before your chemotherapy and Yescarta treatments.

Yescarta cost

To learn about the cost of Yescarta, talk with your doctor, pharmacist, or insurance company.

Before approving coverage for Yescarta, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.

If you’re not sure if you’ll need to get prior authorization for Yescarta, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Yescarta, or if you need help understanding your insurance coverage, help is available.

Kite Pharma Inc., the manufacturer of Yescarta, offers a program called Kite Konnect. This program may include financial support for people who qualify. For more information and to find out if you’re eligible for support, call 844-454-5483 or visit the program website.

Biosimilar version

Yescarta is available only as a brand-name medication. It’s not currently available in biosimilar form.

A biosimilar is a drug that’s similar to a brand-name biologic medication. Biosimilars are based on biologic drugs, which are made from parts of living organisms. Yescarta is a biologic drug.

Biosimilars tend to cost less than the brand-name drugs they’re based on.

How Yescarta is given

Yescarta is a type of gene therapy called chimeric antigen receptor T-cell (CAR T-cell) therapy. With this type of treatment, your T cells (a type of immune system cell) are collected from your blood and modified in a laboratory. The modified cells are then infused back into your blood. The modified T cells then attach to your cancer cells and kill them.

Yescarta is given as an intravenous (IV) infusion, which is an injection into your vein over a period of time. Yescarta infusions typically last less than 30 minutes.

However, after receiving your infusion, you’ll need to remain at the facility for at least 7 days. This is so your doctor can closely monitor you for any serious side effects. For more information, see the “Yescarta side effects” section above.

Yescarta can only be given by a healthcare professional in a REMS-certified facility. REMS (Risk Evaluation and Mitigation Strategies) is a program created by the Food and Drug Administration (FDA). It helps make sure that drugs are used safely and provided by specially trained healthcare professionals.

How Yescarta works

Yescarta is FDA-approved for use in adults with relapsed or refractory large B-cell lymphoma, which is a type of non-Hodgkin lymphoma. “Relapsed” means the cancer came back after past treatment. “Refractory” means the cancer hasn’t gotten better with other treatments.

What happens with lymphoma

Lymphoma is cancer that affects your lymphatic system. Non-Hodgkin lymphoma is the most common type of lymphoma. It usually develops in B cells and T cells, which are immune system cells.

The lymphatic system is part of your immune system, which fights off disease. The lymphatic system consists of vessels that transport a substance called lymph throughout your body. Lymph is a fluid that contains white blood cells and helps carry bacteria out of your body tissues.

Some people don’t notice any symptoms with lymphoma. Other people may experience:

• swelling in the abdomen (belly), armpits, groin, or neck (where lymph nodes are located)
• fever
• night sweats or chills
• fatigue (lack of energy)
• itching with an unknown cause
• weight loss

What Yescarta does

Yescarta works by attaching directly to a protein called CD19, which can be found on both cancerous and noncancerous B cells. When Yescarta attaches to CD19, it sends signals to activate your immune system. This helps your immune system cells find and kill cancer cells.

How Yescarta is made

Yescarta is a type of gene therapy called chimeric antigen receptor T-cell (CAR T-cell) therapy. With this type of treatment, your T cells (a type of immune system cell) are collected from your blood and modified in a laboratory.

Your T cells are modified with a special protein, called a chimeric antigen receptor (CAR), that’s found on your cancer cells. Then large amounts of modified T cells are created and infused back into your blood through an intravenous (IV) infusion.

How long does it take to work?

Yescarta begins working as soon as the infusion begins. However, it may take several weeks before you notice improvement in your symptoms.

If you have questions about when you should expect to see your symptoms begin to improve, talk with your doctor.

Yescarta and pregnancy

You shouldn’t use Yescarta while pregnant. This is because the drug hasn’t been studied during pregnancy in human or animal clinical trials. Therefore, it’s not known if a fetus will be exposed to the drug. However, based on how the drug works, it’s thought that it could cause harm to a fetus.

If you’re able to become pregnant, your doctor will have you take a test before receiving Yescarta to make sure you’re not pregnant.

Yescarta and birth control

You shouldn’t use Yescarta during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Yescarta.

For more information about taking Yescarta during pregnancy, see the “Yescarta and pregnancy” section above.

Yescarta and breastfeeding

It isn’t known if Yescarta is safe to use while breastfeeding. There haven’t been any studies in humans or animals to see if the drug passes into breast milk. Therefore, it’s not known what effect, if any, the drug could have on a breastfed child.

If you have questions about breastfeeding while taking Yescarta, talk with your doctor.

Common questions about Yescarta

Here are answers to some frequently asked questions about Yescarta.

Is Yescarta gene therapy?

Yes. Yescarta is a type of gene therapy called chimeric antigen receptor T-cell (CAR T-cell) therapy. With this kind of treatment, your T cells (a type of immune system cell) are collected from your blood and modified in a laboratory.

Your T cells are modified with a special protein called CAR that’s found on your cancer cells. Then large amounts of modified T cells are created and infused back into your blood through an intravenous (IV) infusion. The modified T cells attach to your cancer cells and kill them.

Will Yescarta cure my cancer?

No, Yescarta won’t cure your cancer. There currently isn’t a known cure for cancer. However, many people taking Yescarta in clinical trials had their tumor shrink. Some people taking Yescarta even experienced complete remission (when tests show no more cancer in your blood).

Talk with your doctor if you have questions about how Yescarta will treat your cancer.

Why is Yescarta available only at a REMS-certified facility?

Although rare, Yescarta can cause side effects that can be life threatening or even fatal. These side effects can occur days or sometimes weeks after a Yescarta infusion. In clinical studies, at least 50% of people who received Yescarta and had these side effects developed them 2 to 4 days after the infusion.

It’s because of these potential side effects that Yescarta can only be given by a healthcare professional in a REMS-certified facility. REMS (Risk Evaluation and Mitigation Strategies) is a program created by the Food and Drug Administration (FDA). It helps make sure that drugs are used safely and provided only by specially trained healthcare professionals. For example, these facilities are required to have special treatments on hand at all times in case you develop serious side effects from Yescarta.

If you have questions about Yescarta and REMS, talk with your doctor or pharmacist.

Why do I need to be monitored daily by my doctor after getting Yescarta?

Yescarta can cause side effects that can be life threatening or even fatal. Although the risk for such side effects is rare, the drug’s manufacturer recommends that your doctor monitor you closely for any signs of serious side effects.

Your doctor will monitor you for at least 7 days at the infusion facility after your dose. Your doctor is required to have special treatments on hand at all times in case you develop serious side effects from Yescarta.

If you have questions about the monitoring you’ll need while taking Yescarta, talk with your doctor. For information about potential side effects from Yescarta, see the “Yescarta side effects” section above.

Can I take Tecartus (KTE-X19) instead of Yescarta for my cancer?

No, Tecartus isn’t an alternative for Yescarta.

Tecartus, previously called KTE-X19, is approved for use in adults with relapsed* or refractory* mantle cell lymphoma. Yescarta, on the other hand, is approved for use in adults with relapsed or refractory large B-cell lymphoma, including:

• diffuse large B-cell lymphoma (DLBCL)
• primary mediastinal large B-cell lymphoma
• high grade B-cell lymphoma
• DLBCL from follicular lymphoma

Like Yescarta, Tecartus is a type of chimeric antigen receptor T-cell (CAR T-cell) therapy. Tecartus contains the active drug brexucabtagene autoleucel. Yescarta contains the active drug ingredient axicabtagene ciloleucel.

If you have questions about which treatments are appropriate for your cancer, talk with your doctor.

* “Relapsed” means the cancer came back after past treatment. “Refractory” means the cancer hasn’t gotten better with other treatments.

Yescarta precautions

This drug comes with several precautions.

FDA warnings

This drug has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous. Due to the risks these warnings describe, Yescarta is only prescribed and administered at certified healthcare facilities.

• Cytokine release syndrome (CRS). CRS occurs when your immune system responds too aggressively to treatment with Yescarta. When this happens, your body releases too many proteins called cytokines. Cytokines send messages that activate your immune system, which can lead to inflammation (swelling and damage) throughout your body. Symptoms of CRS in clinical trials included fever, hypotension (low blood pressure), fast heart rate, and chills. In rare cases, CRS can be fatal. CRS should be treated with tocilizumab used alone or with corticosteroids.
• Neurotoxicities. A neurotoxicity is a problem affecting the brain or nervous system. In rare cases, these problems can be life threatening or fatal. In clinical studies, the most common problems were encephalopathy (changes in brain function or structure), headache, tremor, and dizziness. They also included aphasia (trouble speaking or understanding what others are saying), delirium, insomnia (trouble sleeping), and anxiety.

Other precautions

Before taking Yescarta, talk with your doctor about your health history. Yescarta may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

• Hepatitis B. Yescarta may reactivate the hepatitis B virus (HBV) in people who’ve had the virus before. Before taking Yescarta, tell your doctor if you’ve had HBV.
• Active infection. Because Yescarta stimulates your immune system, you should wait until your infection clears before taking Yescarta. Otherwise, your immune system may become overactive. Be sure to tell your doctor if you have an active infection before receiving your Yescarta infusion.
• Neurologic problems. Yescarta can cause certain neurologic side effects. If you have a history of neurologic problems, such as seizures or memory loss, Yescarta may not be right for you. Before receiving Yescarta, talk with your doctor about any neurologic problems you’ve had.
• Lung or breathing problems. Yescarta can raise your risk for certain infections, including infections in your lungs. Yescarta may also cause shortness of breath and other breathing problems. For this reason, tell your doctor about any lung or breathing problems you may have before receiving Yescarta.
• Heart, liver, or kidney problems. Yescarta can cause side effects that affect your heart, kidneys, or liver. For this reason, tell your doctor about any history of heart, kidney, or liver problems you may have before taking Yescarta.
• Allergic reaction. If you’ve had an allergic reaction to Yescarta or any of its ingredients, you shouldn’t take Yescarta. Ask your doctor which other medications may be better options for you.
• Pregnancy. You shouldn’t use Yescarta while pregnant. For more information, see the “Yescarta and pregnancy” section above.
• Breastfeeding. It isn’t known if Yescarta is safe to take while breastfeeding. For more information, see the “Yescarta and breastfeeding” section above.

Note: For more information about the potential negative effects of Yescarta, see the “Yescarta side effects” section above.