What’s the mechanism of action of Carvykti?

Carvykti is a personalized CAR T cell therapy that works by helping your own white blood cells (called T cells) recognize and fight multiple myeloma, a type of bone marrow cancer. Carvykti is given as a one-time intravenous (IV) infusion of genetically modified T cells called CAR T cells.

Your T cells in your immune system normally seek out special proteins on cancer cells but can’t always find these proteins due to structural changes.

In Carvykti therapy, your T cells are collected from your blood and then genetically changed by adding a chimeric antigen receptor (CAR). This creates your personalized CAR-T cell therapy.

Carvykti CAR T cells then find and attack the B-cell maturation antigen (BCMA) protein found on the outside of most multiple myeloma cancer cells as well as normal plasma cells.

Carvykti is used when at least one other treatment has not worked or has stopped working to treat multiple myeloma.

Is Carvykti FDA approved?

Yes, Carvykti (ciltacabtagene autoleucel) was first approved by the U.S Food and Drug Administration on (FDA) February 28, 2022 to treat multiple myeloma in adults.

It is classified as a B-cell maturation antigen (BCMA)- directed genetically modified autologous T cell immunotherapy and is manufactured by Janssen Biotech Inc.

What is Carvykti for?

Carvykti is approved by the FDA to treat multiple myeloma in adults.

• It’s used after you have received 1 or more lines of treatments and your cancer came back or you stopped responding.
• Your prior treatments may include a proteasome inhibitor and an immunomodulatory agent, and you are refractory to lenalidomide, meaning it no longer works.

Learn More: Boxed Warning for Carvykti from the FDA

How will I receive Carvykti?

Making and receiving your personalized Carvykti CAR T cell therapy is a multi-step process. Your healthcare providers will provide all the details you need for your treatment.

1. Carvykti is made by collecting your T cells (white blood cells) from your blood through a procedure called leukapheresis, which can take 3 to 6 hours.
2. The T cells are then sent to a specialized manufacturing facility and genetically modified to create CAR-T cells. These cells are then grown and multiplied in the lab, which can take up to 4 to 5 weeks. While your Carvykti is being made you may receive other medicines to help treat your multiple myeloma so it does not worsen.
3. Before you receive your Carvykti treatment, you may receive chemotherapy for a few days to help the CAR T cell therapy better respond to your cancer. This chemotherapy is usually not very strong. CAR T cells work best when there are cancer cells to attack.
4. When your CAR-T cell therapy is ready it will be sent back to your healthcare team. You will then receive the CAR-T cells back into your body through a single intravenous (IV) infusion of Carvykti. The Carvykti infusion usually takes 30 to 60 minutes. These personalized CAR-T cells can then multiply in your body and are better able to find the cancer and help fight it.
5. You will receive your Carvykti at a certified healthcare facility that can provide specialized care for this type of therapy. This facility may not be close to your home town and you may need to make plans to travel.
6. After your infusion you will be followed closely at the specialized facility for at least 10 days. You and your caregiver will need to plan to be close to the facility where you received treatment for at least 4 weeks.
7. After getting Carvykti, your healthcare provider will follow you closely to be sure your treatment is working and to look for side effects. You will need special blood tests, too.
8. You may need to be hospitalized again if you develop serious side effects. This is so your side effects can be treated and it is safe for you to leave the hospital.

Related: Carvykti side effects (in detail)

This is not all the information you need to know about Carvykti (ciltacabtagene autoleucel) for safe and effective use and does not take the place of your healthcare provider's directions. Review the full product information and discuss any questions you have with your doctor or other health care provider.

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