ABECMA® (idecabtagene vicleucel)
Abecma® (idecabtagene vicleucel or “ide-cel” for short) is the first-in-class B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T-cell immunotherapy approved by the U.S. Food and Drug Administration (FDA) for use in myeloma.
In March 2021, Abecma was approved by the FDA for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have had 4 or more prior lines of therapy. In April 2024, the FDA expanded its approval of Abecma to patients with RRMM after 2 or more prior lines of therapy. By expanding the previous indication, therapy with Abecma is now available to patients earlier in their treatment journey.
The FDA approval of Abecma was based on data from the KarMMa-3 phase III clinical trial, which demonstrated a progression-free survival (PFS) of approximately 13 months in the Abecma arm of the study vs. 4 months in the control arm with patients on standard treatment regimens.
Personalized immune therapy
Abecma is a personalized immune therapy that is manufactured for each individual patient using the patient’s own T cells (a type of white blood cell) and delivered as a one-time infusion. The patient’s own T cells are genetically modified to recognize and attack BCMA, a protein that is nearly universally expressed on myeloma cells.
Administration of Abecma
Before giving you Abecma, your doctor will prepare your body with chemotherapy for 3 days. Abecma is administered by an intravenous (IV) infusion given in one or more infusion bags. The infusion usually takes up to 30 minutes for each infusion bag. For at least 7 days after the infusion of Abecma, you will be monitored daily at the certified healthcare facility where you received your treatment.
Important safety information
Abecma may cause side effects that are severe or life-threatening. Immediately alert your doctor or get emergency medical help if you experience difficulty
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breathing, fever of 100.4°F/38°C or higher, chills or shivering, confusion, dizziness or lightheadedness, tremors (shaking or twitching), fast or irregular heartbeat, severe fatigue, severe nausea, vomiting, or diarrhea.
Abecma can cause temporary memory and coordination problems, sleepiness, confusion, dizziness, and seizures. If you are not mentally alert, don’t drive, operate heavy machinery, or engage in activities that could be dangerous.
The safety profile of Abecma is well-established and predictable, including cytokine release syndrome (CRS) and neurologic toxicities that are mostly low-grade with early onset and resolution.
Other common side effects of Abecma include fatigue, decreased appetite, headache, difficulty speaking or slurred speech, and cough. Immediately alert your doctor if you develop any of these symptoms after receiving Abecma.
Your doctor will check to see that your treatment is working and help you with any side effects that may occur. Your doctor may give you other medicines to treat your side effects.
Having Abecma in your blood may cause a false-positive human immunodeficiency virus (HIV) test result by some commercial tests.
Support
Abecma is administered at certified treatment centers, and appropriate use is supported by the Risk Evaluation and Mitigation Strategy (REMS) program. For more information, please visit abecma.com or call 1.888.805.4555.
Use the QR code below or visit medications.myeloma.org for more information.
As always, the IMF urges you to discuss all medical issues with your doctor and to contact the IMF InfoLine with your myeloma-related questions and concerns at 1.818.487.7455 or infoline@myeloma.org.
Myeloma Foundation 4400 Coldwater Canyon Avenue #300 – Studio City, CA 91604 1.818.487.7455 TheIMF@myeloma.org myeloma.org