T-cell
T cells are a type of immune cell
that patrols the body for signs
of infection and disease, and then
starts a response to attack them.
But sometimes cancer cells are structured in a way that prevents
T cells from recognizing or
attacking them.
CART-cell
CAR-T cell therapy works through the collection and genetic modification of your body's own T cells to create personalized CAR-T cells that will recognize and fight your cancer. Your CAR-T cells are then returned to your body in a one-time infusion.
CART-cell-multiply
CAR-T cells will multiply in your
body so that you have even more
cells seeking out and destroying
cancer cells.
CART-cell-bcma
CARVYKTI® CAR-T cells are designed to find and attack BCMA, a protein
found on the outside of nearly all
multiple myeloma cells as well as on
normal plasma cells. BCMA is 
over-expressed on multiple 
myeloma cells.
BCMA=B-cell maturation antigen; CAR-T=chimeric antigen receptor-T cell.

PATIENT RESPONSE IN A CLINICAL STUDY

CARVYKTI® is a treatment administered in a one-time infusion that was studied in CARTITUDE-4, a clinical study of 419 adults with relapsed or refractory multiple myeloma. In the clinical study, patients had received at least one treatment regimen that included a proteasome inhibitor and an immunomodulatory agent, and had not responded to lenalidomide, before their symptoms returned or their disease stopped responding to treatment.
Carvykti® Patients Lived longer Without Their Disease Progressing or passing away compared to those RECEIVING one of two standard THERAPY COMBINATIONS
In a clinical study of 419 patients, 208 were treated with CARVYKTI® and 211 were treated with one of two types of
standard MM therapy.

CARVYKTI® was compared to patients receiving: daratumamab, pomalidomide, and dexamethasone or bortezomib, pomalidomide, and dexamethasone

76% of patients who took CARVYKTI® were living without their diseases worsening compared to 49% of patients who took standard therapy76% of patients who took CARVYKTI® were living without their diseases worsening compared to 49% of patients who took standard therapy

MM=multiple myeloma; RRMM=relapsed or refractory multiple myeloma.

more RRMM Patients
Responded to
Carvykti® compared
to THOSE RECEIVING
one of Two
Standard THERAPY
COMBINATIONS
In a clinical study of 419 patients, 208 were treated with CARVYKTI® and 211 were treated with one of two types of standard MM therapy.

CARVYKTI® was compared to patients receiving: daratumamab, pomalidomide, and dexamethasone or bortezomib, pomalidomide, and dexamethasone

Chart showing CARVYKTI® 85% ORR versus 67% of one of two standard therapy combinations
Overall Response Rate (ORR): The percentage of patients who have any kind of response to multiple myeloma treatment.
Types of Treatment Responses
  • Stringent complete response (sCR): the best results of treatment with a drug, in which the doctor is unable to
    observe any signs or symptoms of the disease through the use of very sensitive techniques, including imaging or
    other specific tests
  • Complete response (CR): when the doctor observed no signs or symptoms of the disease as seen through
    standard tests, including imaging or other specific blood and bone marrow tests after treatment
  • Very good partial response (VGPR): a treatment outcome in which there is a greater than 90% decrease in M-protein
  • Partial response (PR): when there is a greater than 50% decrease in M-protein and disappearance of some
    (but not all) signs and symptoms of cancer

MM=multiple myeloma; RRMM=relapsed or refractory multiple myeloma.

CARVYKTI® PATIENTS
HAD A Longer lasting RESPONSE COMPARED
TO THOSE RECEIVING ONE OF TWO
Standard THERAPY
COMBINATIONS
In a clinical study of 419 patients, 208 were treated with CARVYKTI® and 211 were treated with one of two types of standard MM therapy.

CARVYKTI® was compared to patients receiving: daratumamab, pomalidomide, and dexamethasone or bortezomib, pomalidomide, and dexamethasone

Median length of time for a patient to have a first response and median duration of responseMedian length of time for a patient to have a first response and median duration of response

*Median is the middle number in a group of numbers arranged from lowest to highest.

In a clinical trial, following a one-time infusion, people experienced the following responses:

SEE THE FULL TREATMENT PROCESS

WHO IS CARVYKTI® FOR?

If you're considering CARVYKTI®, you've already been treated with at least one treatment regimen that contained a proteasome inhibitor, and an immunomodulatory agent, and you have not responded to lenalidomide.

In addition, your multiple myeloma has either returned or has stopped responding to treatment, and your doctor has determined that it's time to take the next appropriate step to help you manage this illness. Talk to your doctor to see if CARVYKTI® is right for you.

SAFETY PROFILE

CARVYKTI® may cause side effects that are severe
or life-threatening and can lead to death.
Call your healthcare provider or get emergency help right away if you experience any of the following:

  • Fever (100.4°F or 38°C or higher)

  • Chills or shaking chills
  • Fast or irregular heartbeat
  • Difficulty breathing
  • Very low blood pressure
  • Dizziness or lightheadedness
Call your healthcare providers or get emergency help right away if you experience effects on your nervous system, some of which can occur days or weeks after you receive your infusion, and may initially be subtle, such as:

  • Feeling confused, less alert, or disoriented

  • Difficulty speaking or slurred speech

  • Difficulty reading, writing, and understanding words
  • Memory loss
  • Loss of coordination affecting movement and balance
  • Slower movements
  • Changes in handwriting

  • Personality changes including reduced ability to express emotions, being less talkative,

    disinterested in activities, and reduced facial expression

  • Tingling, numbness, and pain of hands and feet
  • Difficulty walking, leg and/or arm weakness
  • Difficulty breathing
  • Facial numbness, difficulty moving face and eye muscles
These are not the only side effects you should be aware of while on treatment with ciltacabtagene autoleucel. For more information, please see the Medication Guide for CARVYKTI® or talk to your healthcare providers.
Cytokine release syndrome (CRS)
CRS, including fatal or life-threatening reactions, occurred after ciltacabtagene autoleucel infusion.
CARVYKTI® can cause a very common side effect called cytokine release syndrome or CRS, which can be severe or fatal. CRS occurs when your immune system becomes overly active. This is caused by the treatment and its effect on the immune cells.
This is why it’s important to share any changes in how you’re feeling with your healthcare providers, regardless of how small they may seem. The members of your healthcare team are experts trained to manage CRS and they’re ready to support you.
In clinical studies, 84% of patients experienced CRS. The median onset of CRS after treatment was 7 days (range: 1-23 days). The median duration was 4 days (range was 1 to 97 days).
Signs and symptoms of CRS may include:

  • Fever

  • Difficulty breathing
  • Dizziness or lightheadedness
  • Nausea
  • Headache
  • Fast heartbeat
  • Low blood pressure
  • Fatigue
Neurologic side effects
Neurologic toxicity side effects can be a life-threatening or even fatal condition where your central nervous system reacts to the infusion.
CARVYKTI® can cause various neurologic side effects, some of which may be severe or fatal. In two studies, 69 people (24%) experienced neurologic toxicities. About one third of these cases were serious or severe.
Some of these neurologic toxicity side effects can be signs of a serious immune reaction associated with CAR-T therapy called immune effector cell-associated neurotoxicity syndrome, or ICANS. In two studies, 36 people (13%) experienced ICANS. These cases ranged from mild to severe. The median time to onset of ICANS was 8 days (range, 1 to 28 days). The median duration of ICANS was 6 days (range, 1 to 1229 days).
Other forms of neurologic toxicity that are distinct from ICANS may include parkinsonism, Guillain-Barré syndrome (GBS), immune mediated myelitis, peripheral neuropathy, and cranial nerve palsies. Some people treated with CARVYKTI® in clinical studies have experienced these other forms of neurologic toxicity. In a separate, ongoing study of CARVYKTI®, one person died after developing GBS. Your healthcare provider will monitor for GBS and provide care as needed.
Signs or symptoms associated with neurologic toxicity, some of which may occur days or weeks following the infusion, may include:

  • Confusion

  • Disorientation
  • Loss of consciousness
  • Seizures
  • Difficulty speaking, reading, or writing
  • Tremor
  • Slower movements
  • Changes in personality
  • Depression
  • Tingling and numbness of hands and feet
  • Leg and arm weakness
  • Facial numbness
These are not all the possible side effects of CARVYKTI®. Tell your healthcare providers immediately if you experience any signs and symptoms of these side effects.
COMMON SIDE EFFECTS
The most common side effects of CARVYKTI® include:

  • Fever (100.4°F/38°C or higher), chills

  • Dizziness or lightheadedness
  • Headache, muscle or joint pain, feeling very tired
  • Altered mental state, confusion
  • Infections
  • Low levels of antibodies (immunoglobulins) in the blood
  • Cough, being short of breath
  • Diarrhea, nausea, decreased appetite, constipation
  • Fast or irregular heartbeat
  • Problems with blood clotting
OTHER POSSIBLE SIDE EFFECTS
In a study comparing CARVYKTI® to standard therapy, there was a higher rate of death in the first 10 months in the CARVYKTI® arm (14%) compared to the standard therapy arm (12%). The increased rate of deaths occurred before receiving CARVYKTI® and after treatment with CARVYKTI®. The reasons for death were progression of multiple myeloma and side effects of the treatment.
CARVYKTI® can increase the risk of life-threatening infections, including COVID-19, that may lead to death. Tell your healthcare providers right away if you develop fever, chills, or any signs or symptoms of an infection.
CARVYKTI® can lower one or more types of your blood cells (red blood cells, white blood cells, or platelets [cells that help blood to clot]) which may make you feel weak or tired, or increase your risk of severe infection or bleeding that may lead to death. After treatment, your healthcare providers will test your blood to check for this. Tell your healthcare providers right away if you get a fever, chills, or any signs or symptoms of an infection, are feeling tired, or have bruising or bleeding.

CARVYKTI® may increase your risk of getting cancers including certain types of blood cancers. Your healthcare provider should monitor you for this.

Having CARVYKTI® in your blood may cause some commercial Human Immunodeficiency Virus (HIV) tests to incorrectly give you an HIV-positive result even though you may be HIV-negative.
These are not all the possible side effects of CARVYKTI®. Tell your healthcare providers immediately if you experience any side effects.
THE CARVYKTI® REMS PROGRAM
What is the CARVYKTI® REMS Program?
A Risk Evaluation and Mitigation Strategy (REMS) program is a drug safety program that the U.S. Food and Drug Administration (FDA) requires for certain medicines with serious safety concerns. Drug companies and healthcare professionals must take extra steps to make sure the benefits of using the drug are more than the risks. The FDA must approve these steps as part of a REMS program.
Due to the risk of serious side effects such as cytokine release syndrome (CRS) and neurotoxicity, which can be life-threatening and can lead to death, CARVYKTI® can only be administered at healthcare settings certified in the CARVYKTI® REMS Program.
As part of the CARVYKTI® REMS Program, you will be given a CARVYKTI® Patient Wallet Card either before or at the time of receiving your CARVYKTI® infusion. Work with your healthcare providers to fill out the card, and be sure to carry your completed CARVYKTI® Patient Wallet Card with you at all times. For more information about the CARVYKTI® REMS Program or to download a replacement card if needed, visit www.CARVYKTIrems.com

Monitoring symptoms of
potential side effects

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