What is ABECMA? ABECMA (idecabtagene vicleucel) is a prescription medicine for the treatment of multiple myeloma in patients who have received at least three kinds of treatment regimens that have not worked or have stopped working. ABECMA is a medicine made from your own white blood cells; the cells are genetically modified to recognize and attack your multiple myeloma cells.

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Managing my multiple myeloma now so

I can help her start her next chapter

—that’s my plan after ABECMA®

Actor portrayal

Managing my multiple myeloma now so

I can help her start her next chapter

—that’s my plan after ABECMA®

Actor portrayal

In a clinical study of 30.9 months follow-up (median*), people treated with ABECMA lived longer without the disease getting worse or passing away, 13.8 months vs 4.4 months with standard treatments.

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

ABECMA is a powerful treatment that may help control multiple myeloma

How was ABECMA studied?

Every clinical study includes different types of people. This ABECMA study (KarMMa-3) is the only phase 3 trial that specifically included people who all received 3 different kinds of medicine: an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. These medicines are the most commonly used in treating multiple myeloma.

In a clinical study of 386 people with relapsed or refractory multiple myeloma, (254 patients received ABECMA; 132 patients received standard treatment†), people received at least 2 prior medicines and were a median* age of 63 years old. The youngest person in the study was 30 years old and the oldest person was 81 years old. Results of the clinical study are based on 30.9 months median* follow-up.

People included in this study had 2 important characteristics that may be seen in people with relapsed/refractory multiple myeloma (RRMM): 100% were triple-class exposed‡ and 95% were daratumumab refractory.

†People who were given standard treatment got one of the following medication combinations: daratumumab, pomalidomide, dexamethasone (DPd); daratumumab, bortezomib, dexamethasone (DVd); ixazomib, lenalidomide, dexamethasone (IRd); carfilzomib, dexamethasone (Kd); or elotuzumab, pomalidomide, dexamethasone (EPd).

‡Patients who have received an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

Everyone enrolled in the ABECMA
clinical study was monitored for results, including:

Image
  • The length of time alive and without the cancer getting worse after treatment, called progression-free survival (PFS)
  • The percentage of patients whose cancer shrinks or disappears after treatment, called overall response rate (ORR)
  • The disappearance of all signs of cancer in response to treatment,§ called a complete response (CR)
  • The length of time cancer responded to treatment without growing or spreading, called duration of response (DOR)

§It does not mean the multiple myeloma has been cured.

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When discussing treatment options with your doctor, it is important to understand the different types of people included in the clinical studies for those medicines, as it can affect the results and how they should be interpreted

Results of clinical study

People who received ABECMA lived 3x longer without multiple myeloma coming back or getting worse compared with standard treatment (13.8 months vs 4.4 months)ll

People receiving ABECMA had 3x more time without multiple myeloma growing or spreading

Clinical trial results showing median progression-free survival with ABECMA® (idecabtagene vicleucel) is 13.3 months compared to 4.4 months on standard treatment Clinical trial results showing median progression-free survival with ABECMA® (idecabtagene vicleucel) is 13.3 months compared to 4.4 months on standard treatment

More people responded to treatment with ABECMA

Clinical trial results showing 71% of patients (181/254) responded to treatment with ABECMA® (idecabtagene vicleucel) compared to 42% of people (55/132) on standard treatment Clinical trial results showing 71% of patients (181/254) responded to treatment with ABECMA® (idecabtagene vicleucel) compared to 42% of people (55/132) on standard treatment

Overall response:

The percentage of people who responded to treatment.

Clinical trial results showing 39% of people (98/254) treated with ABECMA® (idecabtagene vicleucel) had a complete response compared to 5% of people (7/132) on standard treatment Clinical trial results showing 39% of people (98/254) treated with ABECMA® (idecabtagene vicleucel) had a complete response compared to 5% of people (7/132) on standard treatment

Complete response or better:

No signs of cancer were found in the body. It does not mean the multiple myeloma has been cured.

People responded to ABECMA for 16.6 months (median).‡

  • This is called duration of response and is the length of time cancer responded to treatment without growing or spreading

Individual results may vary.

Foot note Standard Treatments:Patients were followed for 30.9 months (median‡).

Foot note Standard Treatments:People who were given standard treatment got one of the following medication combinations: daratumumab, pomalidomide, dexamethasone (DPd); daratumumab, bortezomib, dexamethasone (DVd); ixazomib, lenalidomide, dexamethasone (IRd); carfilzomib, dexamethasone (Kd); or elotuzumab, pomalidomide, dexamethasone (EPd).

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

More people achieved a complete response with ABECMA

than with standard treatment

Bar chart illustrating the response rate of patients to ABECMA Bar chart illustrating the response rate of patients to ABECMA

llProgression-free survival results. Progression-free survival is the amount of time a person was alive and without the cancer getting worse after treatment. People in the clinical study were followed for 30.9 months (median*). Individual results may vary.

†People who were given standard treatment got one of the following medication combinations: daratumumab, pomalidomide, dexamethasone (DPd); daratumumab, bortezomib, dexamethasone (DVd); ixazomib, lenalidomide, dexamethasone (IRd); carfilzomib, dexamethasone (Kd); or elotuzumab, pomalidomide, dexamethasone (EPd).

People who received ABECMA in the clinical study who had a partial response or better responded to ABECMA for 14.8 months.

At a median* follow-up
of 15.9 months, people who received ABECMA in the clinical study who had a complete response or better responded
to ABECMA for 20 months.
image

No matter where you are in your treatment journey, it's a good idea to ask your healthcare team about ABECMA to understand your options. Your doctor will consider many factors when deciding if ABECMA is right for you now—or in the future.

Need help getting started? Download this discussion guide to help you start the conversation.

What do I need to know about possible side effects?

SEE THE POSSIBLE SIDE EFFECTS

Download helpful
resources

VIEW RESOURCES

Learn more about
receiving ABECMA

See the treatment process

Important Facts About ABECMA®

(idecabtagene vicleucel)

This is a summary of important information that you need to know about ABECMA. Your healthcare team can work with you to help answer any questions you may have about this medication. Keep this document in a safe place, so you can refer to it before and during your treatment.

Look out for the following
icons as you read:

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healthcare team

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provider right away

Helpful information
to remember

What is ABECMA?

ABECMA is a prescription medicine used to treat adults with relapsed or refractory multiple myeloma (MM), when:

you have tried two or more kinds of treatments that have not worked or have stopped working, AND

you have received at least one therapy from each of these drug classes:

  • an immunomodulatory agent
  • a proteasome inhibitor
  • an anti-CD38 antibody

WARNING: RISK OF SERIOUS SIDE EFFECTS

ABECMA may cause side effects that are life-threatening and can lead to death, including risk of cytokine release syndrome (CRS), neurologic toxicity, infections, low blood cell counts (cytopenia), and certain types of blood cancers.

Call your healthcare provider or get emergency help right away if you experience any of the following symptoms:

  • trouble breathing
  • fever (100.4°F/38°C or higher)
  • chills or shivering
  •  
  • confusion
  • feeling dizzy or lightheaded
  • shaking or twitching (tremor)
  • fast or irregular heartbeat
  • feeling severely tired or weak
  • severe nausea, vomiting, or diarrhea

Because of the risk of serious side effects, your healthcare provider will give you an ABECMA Patient Wallet Card that describes symptoms to look out for that require emergency medical care right away. It’s important that you tell your healthcare providers that you have received ABECMA and to show them your ABECMA Patient Wallet Card. Your healthcare provider may give you other medicines to treat your side effects.

How will I receive ABECMA?

ABECMA is a CAR (chimeric antigen receptor) T-cell therapy. It is a prescription medicine made using your own white blood cells. These white blood cells have been changed (genetically modified) to find and attack your multiple myeloma cells. ABECMA is given as an intravenous (IV) infusion.

Before receiving your ABECMA infusion:

Your blood cells will be collected by a process called leukapheresis (LOO-kuh-feh-REE-sis), sometimes called apheresis.

Your blood cells will be sent to a manufacturing site to make your ABECMA. Based on clinical trial experience, your ABECMA will be ready to be shipped back to your healthcare provider about 4 weeks after your cells are received at the manufacturing site, but the time may vary.

Your healthcare provider will give you 3 days of chemotherapy to prepare your body before receiving your ABECMA treatment.

On the day of your ABECMA infusion:

You will receive ABECMA through a tube (catheter) placed into your vein (intravenous infusion). Your dose of ABECMA may be given in one or more infusion bags. Each infusion bag usually takes up to 30 min.

After receiving your ABECMA infusion:

For at least 1 week (7 days) after receiving ABECMA, you will stay at the facility where you received your treatment and be monitored daily.

For 4 weeks after receiving ABECMA, you should plan to stay close (within 2 hours) to the facility where you received your treatment. During this time, your healthcare provider will check to see that your treatment is working and help you with any side effects that may occur.

What should I avoid after receiving ABECMA?

Do not drive, operate heavy machinery, or do any other activity that could be dangerous if you are not mentally alert, for at least 8 weeks after you get ABECMA. This is because ABECMA may affect your ability to be mentally alert in the following ways:

  • temporary memory and coordination problems
  • sleepiness
  • dizziness
  • confusion
  • seizures

Do not donate blood, organs, tissues, or cells for transplantation.

What are the possible or reasonably likely side effects of ABECMA?

Serious side effects

ABECMA can increase the risk of serious side effects. A serious side effect is a side effect that is severe or life-threatening and can lead to death. The serious side effects of ABECMA include, but are not limited to:

Early deaths. In a clinical study comparing ABECMA to standard treatments, a higher proportion of people died in the first 9 months from when they were assigned to receive ABECMA compared to people assigned to receive standard treatments. The higher rate of early death was seen before people received ABECMA, and the main reason was that their multiple myeloma had gotten worse. There was also an increase in the rate of death from side effects after receiving ABECMA.

Cytokine release syndrome (CRS). ABECMA can increase the risk of CRS, a very common side effect which can be severe or fatal. CRS happens when the immune system responds to an infection or a drug more aggressively than it should. Symptoms to look out for include:

  • fever (100.4°F/38°C or higher)
  • trouble breathing
  • dizziness or lightheadedness
  • nausea
  • headache
  • fast heartbeat
  • low blood pressure
  • feeling tired or weak

Infections. ABECMA can increase the risk of life-threatening infections that may lead to death. Symptoms to look out for include:

  • fever (100.4°F/38°C or higher)
  • chills
  • any other signs or symptoms of an infection

Low blood cell counts (cytopenia). ABECMA can lower the amount of one or more types of your blood cells (red blood cells, white blood cells, or platelets), which may make you feel weak or tired, and could increase your risk of severe infection or bleeding. After treatment, your healthcare provider will test your blood to check for this. Symptoms to look out for include:

  • fever (100.4°F/38°C or higher)
  • feeling weak or tired
  • bruising
  • bleeding

Other (secondary) blood cancers. ABECMA may increase your risk of getting certain types of cancers, including certain types of blood cancers. You may hear your healthcare provider call these "secondary hematological malignancies."

Your healthcare provider should monitor you for any signs of secondary cancers.

ABECMA may cause a false-positive HIV (Human Immunodeficiency Virus) test result by some commercial tests.

Call your healthcare provider right away if you have any of these symptoms after receiving ABECMA. Remember to bring and show your ABECMA Patient Wallet Card to any healthcare provider who treats you.

Most common side effects

The most common side effects of ABECMA include:

  • feeling tired or weak
  • fever (100.4°F/38°C or higher)
  • chills or shivering
  • severe nausea or diarrhea
  • decreased appetite
  • headache
  • dizziness or lightheadedness
  • confusion
  • trouble speaking or slurred speech
  • cough
  • trouble breathing
  • fast or irregular heartbeat
  • feeling tired or weak
  • fever (100.4°F/38°C or higher)
  • chills or shivering
  • severe nausea or diarrhea
  • decreased appetite
  • headache
  • dizziness or lightheadedness
  • confusion
  • trouble speaking or slurred speech
  • cough
  • trouble breathing
  • fast or irregular heartbeat

These are not all of the possible side effects of ABECMA.

Talk to your healthcare team for medical advice about side effects. You are encouraged to report side effects to Bristol Myers Squibb at ABECMA.com or by calling 1-888-805-4555, or to the FDA by calling 1-800-FDA-1088.

For more information, please see the U.S. Full Prescribing Information, including Boxed WARNINGS, and Medication Guide for ABECMA. Talk to your healthcare provider for more information about this medication.



2012-US-2400149 04/2024