Yescarta® (axicabtagene ciloleucel) Becomes First CAR T-Cell Therapy Approved for Indolent Follicular Lymphoma

The U.S. Food and Drug Administration (FDA) has approved Yescarta® (axicabtagene ciloleucel) to treat adults with relapsed or refractory follicular lymphoma (FL) after 2 or more lines of systemic therapy. This makes Yescarta the first CAR T-cell therapy approved for indolent follicular lymphoma.¹

Follicular lymphoma (FL) is a type of indolent non-Hodgkin lymphoma (iNHL). In people with FL, cancerous tumors grow slowly. However, these tumors may become more aggressive over time. FL is the most common form of indolent lymphoma and the second most common type of lymphoma. FL makes up 22 percent of all lymphomas. Currently, there are limited options to treat relapsed or refractory indolent FL after 2 or more lines of therapy.¹

The FDA granted Yescarta as Breakthrough Therapy and Priority Review. Breakthrough Therapy means the FDA helps speed up the development and review of drugs that treat serious or life-threatening conditions. Priority Review is granted when a new drug seems promising and may greatly help a disease. Priority Review means the FDA will decide whether to approve Yescarta in 6 months. It is only for drugs that seem to work better or are safer than current treatments.^2,3

Yescarta is currently only available through a restricted program called the Risk Evaluation and Mitigation Strategies (REMS). This is because Yescarta carries the risk of cytokine release syndrome (CRS) and damage to the brain or nervous system (neurotoxicity).¹

What are the ingredients in Yescarta?

The active ingredient in Yescarta is axicabtagene ciloleucel.⁴

How does Yescarta work?

Yescarta is an immunotherapy drug known as a chimeric antigen receptor (CAR) T-cell therapy. It works by sticking to a protein called CD19, which is found on both cancer and noncancerous cells. When Yescarta attaches to CD19 proteins, it sends a signal to activate your immune system. This helps your immune system find and kill cancer cells.⁴

Evidence for Yescarta

Yescarta was approved based on the results of the Zuma-5 study. It is an ongoing, single-arm (everyone takes the study drug), open-label, multicenter study. There are 146 adults in the study who have received at least 2 previous lines of systemic therapy.

The results of the study show:¹

• 91 percent of people with relapsed or refractory FL responded to a single Yescarta infusion.
• At 18 months, about 74 percent were still in remission. The median duration of response has not yet been reached.

Researchers will continue to collect data on Yescarta for further approval.

What are the possible side effects of Yescarta?

The most common side effects of Yescarta include:^1,4

• Fever and chills
• Low blood pressure
• Fatigue
• Headache
• Decreased appetite
• Nausea and vomiting
• Diarrhea and constipation
• Cough
• Dizziness
• Tremor
• Low blood oxygen (hypoxia)
• Infections

Rare but serious side effects of Yescarta include:^1,4

• Brain damage
• Lung infection
• Kidney problems
• Fast or irregular heartbeat
• Heart failure and cardiac arrest

Yescarta may also cause cytokine release syndrome (CRS) in some people. CRS is a life-threatening or fatal reaction. CRS is caused by a large, rapid release of cytokines (a type of protein that has an effect on the immune system) into the blood from immune cells affected by immunotherapy. Signs of CRS include:^1,4,5

• Fever
• Nausea
• Headache
• Rash
• Rapid heartbeat
• Low blood pressure
• Trouble breathing

If you experience any side effects that may be life-threatening, contact 911 right away.

These are not all the possible side effects of Yescarta. Talk to your doctor about what to expect or if you experience any changes that concern you during treatment with Yescarta.

Things to know about Yescarta

Yescarta can harm an unborn baby. Women who can become pregnant should not use Yescarta. There is no information on whether Yescarta is safe to take while breastfeeding. Talk to your doctor about your options for birth control and breastfeeding while taking Yescarta.⁴

Healthcare facilities that dispense and administer Yescarta must enroll and comply with REMS requirements. Doctors who prescribe, dispense, or administer Yescarta must be trained about CRS and neurologic toxicity management.¹

Before beginning treatment for lymphoma, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.

For more information, read the full prescribing information for Yescarta.