FDA Approves Gene Therapy Tecartus For Relapsed Or Refractory Mantle Cell Lymphoma

The U.S. Food and Drug Administration (FDA) has approved Tecartus for the treatment of adults with mantle cell lymphoma (MCL). Tecartus (brexucabtagene autoleucel) is a type of gene therapy. It is for people whose cancer has relapsed or does not respond to other treatment options (called relapsed or refractory).^1,2

Tecartus was granted Priority Review and Accelerated Approval by the FDA. It was also named as a Breakthrough Therapy. These are granted to new drugs that are very promising and could make a big impact on the treatment of a serious condition. These programs help drugs like Tecartus become available sooner.^1,2

What are the ingredients in Tecartus?

The active ingredient in Tecartus is brexucabtagene autoleucel.^1,2

How does Tecartus work?

Tecartus belongs to a group of drugs known as immunotherapy. It is a CD-19-directed genetically modified autologous T cell therapy. This means it uses normal T cells that have been engineered to do something different than usual. This is a type of gene therapy. Another classification for Tecartus is CAR (chimeric antigen receptor) T cell therapy.^1,2

T cells are immune cells that help fight infections and cancers. To make a dose of Tecartus, a person’s T cells are collected and changed. A new gene is introduced into these cells to make them better at fighting cancer cells. These changed cells are then put back into the person they came from.^1,2

Once back in the body, these changed cells activate other immune system cells. This sets off a reaction that specifically targets the cancer. By turning the immune system on to fight a person’s MCL in such a specific way, it may be possible to slow or stop the spread of their cancer.^1,2

Tecartus in clinical trials

Tecartus was studied in the ZUMA-2 clinical trial. The trial included 60 people with relapsed or refractory MCL who had tried several other treatment options in the past.^1,2

The objective response rate, or percent of people whose cancer shrunk or disappeared, was around 80 percent. More than 50 percent of people achieved complete remission.^1,2

The FDA has required that the makers of Tecartus continue studying its effects long-term in those who have received the treatment.^1,2

What are the possible side effects of Tecartus?

Some of the most common side effects of Tecartus include:^1,2

• Fever
• Nausea
• Low white or red blood cell counts
• Low blood pressure (causing dizziness, lightheadedness, tiredness, shortness of breath, or headache)
• Confusion or difficulty with speech
• Fast heartbeat
• Diarrhea

These are not all the possible side effects of Tecartus. Talk to your doctor about what to expect or if you experience any changes that worry you.

Things to know about Tecartus

Tecartus has 2 black box warnings for cytokine release syndrome and neurological issues. Both can be life-threatening if they are severe. These risks are so serious that there are several decisions that must be made by a doctor or hospital before using Tecartus. This is to make sure that the benefits outweigh the risks for the person receiving the treatment.^1,2

In cytokine release syndrome (CRS), the body’s immune system malfunctions and goes into overdrive. Infection-fighting cells release chemicals causing widespread inflammation. This severe inflammation and immune system dysfunction can cause a variety of symptoms. Some of these include:^1,2

• Fever
• Chills
• Fatigue
• Confusion
• Changes in breathing, blood pressure, or heart rate

There are many different symptoms of CRS. Your doctor can give you a complete list of signs to watch for. Significant, whole-body inflammation can be life-threatening if not addressed. People who have an active infection or a previously existing inflammatory disorder should not take Tecartus.^1,2

Rarely, serious damage to the brain or nervous system can occur and may happen alongside CRS. This includes:^1,2

• Seizures
• Changes in consciousness
• Swelling of the brain
• Tremors
• Confusion
• Speech problems

Tell your doctor about any pre-existing neurological issues you have before starting Tecartus.

Some people may have an allergic reaction to Tecartus during infusion. Additionally, since blood cell counts may decrease while taking the drug, the risk of infection and secondary cancers may be increased. Talk to your doctor for more information on the rare but serious side effects of Tecartus.

There is not enough information about Tecartus and pregnancy to know if this drug is safe to use when pregnant. The risk for birth defects and miscarriage is not known. Prior to using this drug, tell your doctor if you are pregnant or plan to become pregnant. It is not known whether this drug is safe to take while breastfeeding.³

It is not known if Tecartus is safe and effective for children.³

Tell your doctor about any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.

For more information, read the full prescribing information of Tecartus.