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THE CARVYKTI™ TREATMENT PROCESS

CARVYKTI™ (ciltacabtagene autoleucel) is an individualized treatment that is prescribed and infused at a Certified Treatment Center. Your primary oncologist will help you set up a consultation at a Certified Treatment Center, which will determine your eligibility and provide your treatment with CARVYKTI™. You’ll still remain in contact and may keep your scheduled appointments with your primary oncologist, who will continue to be involved in your care throughout this process and especially when you return home for longer-term monitoring and follow-up care.

Therapy with CARVYKTI™ is a 5-step process that generally takes about 2 to 3 months to complete.

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STEP 1: CELL COLLECTION

3 TO 6 HOURS

Some of your blood is drawn into a machine that separates the white and red blood cells, collects some of the white blood cells (including T cells), and returns the rest of the blood to your body. This process is called leukapheresis (loo-kuh-fur-ee-sis). This process may take 3 to 6 hours and may need to be repeated.

Between cell collection and pre-infusion treatment, your doctor may prescribe additional therapy to treat your multiple myeloma, often called bridging therapy.†

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STEP 2: GENETICALLY MODIFYING YOUR T CELLS

~4 WEEKS*

Your white blood cells are then frozen and sent to a manufacturing site, where the T cells are separated out and customized into your CARVYKTI™ CAR-T cells. This is done by genetically modifying your T cells to be able to recognize BCMA on the surface of multiple myeloma cells. Your CARVYKTI™ CAR-T cells are then frozen and sent to your CARVYKTI™ Certified Treatment Center.

Between cell collection and pre-infusion treatment, your doctor may prescribe additional therapy to treat your multiple myeloma, often called bridging therapy.†

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STEP 3: PRE-INFUSION TREATMENT

3 DAYS

A few days before your CARVYKTI™ infusion, you’ll receive chemotherapy infusions with cyclophosphamide and fludarabine. These infusions will help prepare your body for the infusion. Each of these infusions will be given to you once a day for 3 days. These infusions are given to help clear out some of your white blood cells to make the necessary space in your immune system for CARVYKTI™. This is also known as lymphodepleting chemotherapy.

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STEP 4: ONE-TIME CARVYKTI™ INFUSION

30 TO 60 MINUTES

About a month after your initial cell collection, and 2 to 4 days after lymphodepleting chemotherapy, you’ll be given your CARVYKTI™ through a one-time intravenous infusion that takes approximately 30 to 60 minutes. Your healthcare providers will guide you through what your infusion day will be like.

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STEP 5: MONITORING

4 WEEKS AND BEYOND

After your infusion of CARVYKTI™, your healthcare providers at the CARVYKTI™ Certified Treatment Center will closely monitor you daily for 10 days following infusion for any signs and symptoms of a reaction to treatment.

You should plan to stay close to the location where you received your treatment for at least 4 weeks. Your healthcare provider will check to see that your treatment is working and help you with any side effects that may occur. You may be hospitalized if you develop serious side effects until your side effects are under control and it is safe for you to leave the hospital.

Your healthcare provider will want to do blood tests to follow your progress. It is important that you have your blood tested. If you miss an appointment, call your healthcare provider as soon as possible to reschedule. After this 4 week monitoring period, your healthcare providers will continue to provide care and partner with you to create a plan for long-term monitoring and regular follow-ups. Let your healthcare providers know if you're not feeling well. Do not drive, or operate heavy machinery, or do other activities that could be dangerous if you are not mentally alert, for at least 8 weeks after you receive CARVYKTI™. This is because the treatment can cause memory and coordination problems, sleepiness, confusion, dizziness, seizures, or other neurologic side effects as discussed by your healthcare provider.

BCMA=B cell maturation antigen; CAR-T=chimeric antigen receptor T cell.

*Timing and outcomes of manufacturing may vary.

†73/97 patients in the CARTITUDE-1 study received bridging therapy.

DOWNLOAD A GUIDE ON MONITORING POTENTIAL CARVYKTI™ SIDE EFFECTS WITH THE HELP OF YOUR HEALTHCARE TEAM

DISCOVER SUPPORT TOOLS FOR YOUR JOURNEY

SEE HOW YOUR CARVYKTI™ CAR-T CELLS ARE MADE

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Multiple myeloma is the third most common hematological malignancy in the United States.

It is characterized by the abnormal accumulation of immune cells called plasma cells in the bone marrow, which produce excessive amounts of antibodies.

The cancerous plasma cells produce high numbers of a marker called B cell maturation antigen, or BCMA, which has been linked to the progression of multiple myeloma.

BCMA is a protein found on nearly all multiple myeloma cells as well as normal plasma cells.

BCMA is overexpressed on multiple myeloma cells compared with healthy plasma cells, making it a potential target for multiple myeloma therapy.

Chimeric antigen receptor T cell therapy, known as CAR-T, is a cancer treatment in which specific immune cells called T cells are collected from the patient, changed and returned to their body to recognize and fight cancer cells.

CARVYKTI™ is a personalized CAR-T cell therapy used for adult patients with multiple myeloma who have received at least four other kinds of treatment and whose multiple myeloma has come back or has stopped responding to treatment.

CARVYKTI™ CAR-T cells have a receptor on their surface designed to find and bind BCMA protein.

The binding triggers CARVYKTI™ to become activated and multiply. This creates more cells that can seek out and destroy cancer cells.

After a one-time infusion of CARVYKTI™, the genetically modified CAR-T cells multiplied in the patient’s blood. This increase in CAR-T cells coincided with a reduction in multiple myeloma tumor burden.

PLANNING FOR TREATMENT WITH CARVYKTI™

Traveling away from home for medical care can be financially and logistically challenging. Support is available for eligible patients and their caregivers.

The MyCARVYKTI™ Patient Support Program

The MyCARVYKTI™ Patient Support Program, sponsored by Janssen Biotech, Inc., and Legend Biotech, is designed to help eligible patients prescribed CARVYKTI™ and their caregivers with support during treatment.

Patients who meet financial and other eligibility requirements, and their caregivers, may receive:

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Assistance with transportation, lodging, and out-of-pocket costs related to meals and other travel expenses associated with treatment at the CARVYKTI™ Certified Treatment Center

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Support from MyCARVYKTI™ Patient Support Specialists, who are available to help guide eligible patients through the enrollment process and assist with program benefits

FIND ADDITIONAL SUPPORT

TIPS FOR TREATMENT

CAREGIVER TIPS

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Your role in supporting the person you care for—the encouragement, emotional support, and practical assistance you provide—makes you an important part of the treatment experience.

You may need to help the person you care for with:
  • Monitoring and tracking side effects
  • Scheduling appointments
  • Providing transportation to appointments and keeping them company
  • Helping communicate with the healthcare providers (for example, providing medical and insurance information, asking questions)
  • Responsibilities at home
  • Emotional support and having someone to talk with
  • Managing their schedule and letting visitors know if they feel up to seeing them

You don’t have to manage this alone. Support is available to help you along the way, and you may want to identify friends or family who can help you as well.