What is Abecma?
Abecma is an immunotherapy (CAR T cell therapy) used to treat multiple myeloma in patients who have received at least four kinds of treatment regimens that have not worked or have stopped working. Abecma is made from your own white blood cells, which are changed so that they can recognize and kill any multiple myeloma cancer cells.
Abecma (idecabtagene vicleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen receptor (CAR) T cell immunotherapy.
Abecma became an FDA-approved medicine on March 26, 2021, after positive results from the Phase II KarMMa trial. The overall response rate for the efficacy in the evaluable population was 72%, and 28% of patients achieved a stringent complete response. The median time to first response was 30 days which ranged from 15 to 88 days.
Who can use Abecma?
Abecma can be used by adult patients who have relapsed or refractory multiple myeloma and have tried four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an antiCD38 monoclonal antibody.
How does Abecma work?
Abecma is a medicine made from your own white blood cells, which are genetically modified so that they can recognize and attack your multiple myeloma cells.
- Your T cells are a type of white blood cell that is part of your immune system that can attack foreign substances in your body.
- On the outside of the multiple myeloma cells are proteins called B-cell maturation antigen (BCMA).
- Normally, T cells do not recognize MM cells, so do not attack and kill them.
- Your T cells (type of white blood cell) are collected and sent to the manufacturing center where they add to the T cell a special receptor called CAR (chimeric antigen receptor) that is designed to bind to certain proteins in cancer cells.
- Your T Cells will now be able to recognize the BCMA protein on the MM cells and kill the cancer cells.
- These changed T cells, called chimeric antigen receptor T cells (CAR T cells), are then grown in large numbers in the laboratory and then given as a one-time Abecma infusion to the MM cancer patient.
How will I receive Abecma?
Abecma is made from your own white blood cells, so your blood will be collected by a process called "leukapheresis" (LOO-kuh-feh-REE-sis). This is when they take blood from your bloodstream and separate white blood cells from the rest of your blood, which they return to the bloodstream.
Your white blood cells will be sent to a manufacturing center to make your Abecma, which usually takes about 4 weeks, but the time may vary.
Before you have your Abecma infusion, you will be given chemotherapy for 3 days to prepare your body.
You are usually given Abecma 2 days after completion of chemotherapy.
Abecma is given as an intravenous infusion through a catheter (tube) placed into your vein. Your dose may be given in one or more infusion bags. The infusion usually takes up to 30 minutes for each infusion bag.
Approximately 30 to 60 minutes before your infusion, you will be given an antihistamine and acetaminophen.
You will be monitored at the certified healthcare facility, where you receive your treatment daily for at least 7 days after the infusion.
You should plan to stay within 2 hours of this location for at least 4 weeks after getting Abecma. Your healthcare provider will check to see that your treatment is working and help you with any side effects that may occur.
Your infusion may be delayed up to 7 days if you have any of the following conditions:
- unresolved serious adverse events (especially pulmonary events, cardiac events, or hypotension), including those after preceding chemotherapies,
- active infections, or inflammatory disorders.
Abecma side effects
Common Abecma side effects may include:
- cytokine release syndrome (confusion, trouble breathing, fast or irregular heartbeats, feeling light-headed or very tired);
- headache, dizziness;
- problems with speech;
- low blood cell counts;
- fever, chills, tiredness, or other signs of infection;
- decreased appetite, severe nausea or diarrhea;
- pain in your bones, joints, or muscles;
- swelling anywhere in your body; or
- cold symptoms such as stuffy nose, sneezing, sore throat, cough.
Serious Abecma side effects:
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
A serious side effect of Abecma is called cytokine release syndrome (CRS). Tell your caregivers right away if you have signs of this condition: fever, chills, trouble breathing, severe vomiting or diarrhea, tremors, shaking, fast or irregular heartbeats, feeling light-headed, or feeling very tired. Your caregivers will have medication available to quickly treat CRS if it occurs.
Also, tell your caregivers or seek emergency medical attention if you have signs of life-threatening nerve problems: problems with speech, problems with thinking or memory, confusion, or a seizure.
Call your doctor at once if you have:
- headaches, dizziness, drowsiness;
- problems with thinking or memory;
- trouble speaking or understanding what is said to you;
- tremors, anxiety, sleep problems;
- right-sided upper stomach pain, vomiting, loss of appetite, yellowing of your skin or eyes, and not feeling well; or
- low blood cell counts - fever, chills, tiredness, flu-like symptoms, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
A serious side effect of Abecma is called cytokine release syndrome, which causes fever, chills, trouble breathing, vomiting, and other symptoms. Your caregivers will have medication available to quickly treat this condition if it occurs.
Abecma can also cause life-threatening nerve problems. Tell your caregivers or seek emergency medical attention if you have problems with speech, problems with thinking or memory, confusion, or a seizure.
Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), including fatal and life-threatening reactions, occurred in patients following treatment with Abecma. HLH/MAS can occur with CRS or neurologic toxicities
Prolonged Cytopenia with bleeding and infection, including fatal outcomes following stem cell transplantation for hematopoietic recovery, occurred following treatment with Abecma.
It is important that you tell your healthcare providers that you have received Abecma and to show them your Patient Wallet Card. Your healthcare provider may give you other medicines to treat your side effects.
Before taking this medicine
Tell your doctor if you have ever had:
- an active infection or inflammation;
- hepatitis B;
- cytomegalovirus; or
- if you have received a vaccine in the past 6 weeks.
Abecma is not recommended for women who are pregnant, and pregnancy after Abecma infusion should be discussed with the treating physician. Women may need to take a pregnancy test before receiving this medicine. You may also need to use birth control to prevent pregnancy during and shortly after treatment with Abecma and chemotherapy.
Assess immunoglobulin levels in newborns of mothers treated with Abecma. If you receive Abecma during pregnancy, your baby's blood may need to be tested after it is born. This is to evaluate any effects the medicine may have had on the baby.
It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.
What should I avoid while using Abecma?
Abecma can cause weakness, drowsiness, confusion, problems with memory or coordination, and seizures. Avoid driving or operating machinery for at least 8 weeks after you are treated with Abecma.
Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during Abecma treatment, and until immune recovery following your infusion.
Do not donate blood, an organ, or any tissues or cells.
What other drugs will affect Abecma?
Other drugs may interact with Abecma, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
- Store Abecma frozen in the vapor phase of liquid nitrogen (less than or equal to minus 130°C).
- Thaw Abecma prior to infusion, according to Abecma Prescribing Information.
Abecma is supplied in one or more infusion bag(s) containing a frozen suspension of genetically modified autologous T cells in 5% DMSO.
Abecma is made specifically for each individual patient with their own white blood cells. Match the identity of the patient with the patient identifiers on the cassette(s) and infusion bag(s) upon receipt.
Manufactured by: Celgene Corporation, a Bristol-Myers Squibb Company, 556 Morris Avenue, Summit, NJ 07901.
Marketed by: Celgene Corporation, a Bristol-Myers Squibb Company (Summit, NJ 07901), and bluebird bio, Inc. (Cambridge, MA 02142).
Abecma is considered an orphan drug because it is used to treat multiple myeloma, a rare disease. Orphan drugs are used to treat, prevent or diagnose rare “orphan” diseases that affect fewer than 200,000 people in the U.S. About 35,000 people are expected to be diagnosed with multiple myeloma in 2023. Continue reading
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