ABECMA (idecabtagene vicleucel)

Abecma^® (idecabtagene vicleucel, “ide-cel”) 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. Abecma is a personalized immune cell therapy delivered as a one-time infusion, manufactured for each individ­ual patient using the patient’s own white blood cells (T cells).

Who Is a Candidate for Abecma?

The FDA has approved Abecma for adult patients with relapsed (myeloma that has come back after prior treatment was stopped) and refractory myeloma (myeloma that is no longer responsive to prior treatments) who have had four or more prior lines of therapy and who have been exposed to at leaset one therapy from each of the major drug classes (“triple-class exposed”): including an immunomodulatory agent (e.g., lenalidomide or pomalidomide), a prote­asome inhibitor (e.g., bortezomib, carfilzomib, or ixazomib),  and an anti-CD38 antibody (e.g., daratumumab or isatuxiumab). The response rates demonstrated in the phase II KarMMa clinical trial of Abecma are unprecedented in relapsed and refractory myeloma, offering an opportunity for patients with heavily pretreated disease to have deep and durable responses.

How Does Abecma Work?

Abecma recognizes and binds to BCMA, a protein that is nearly uni­versally found on myeloma cells, leading to the death of BCMA-expressing cells. The patient’s own T cells are genetically modified to recognize and attack BCMA on the surface of the patient’s myeloma cells.

How Is Abecma Given?

Before giving you Abecma, your doctor will prepare your body by giving you low-dose chemotherapy for three days. Your Abecma dose is administered by an intravenous (into the vein) 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 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 call your healthcare provider or get emergency help if you experience any of the following: difficulty breathing, fever of 100.4°F/38°C or higher, chills or shivering, confusion, dizziness or lightheadedness, shaking or twitching tremors, 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 do other activities that could be dangerous.

Possible Side Effects of Abecma

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. 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.

The most common side effects of Abecma are fatigue, fever of 100.4°F/38°C or higher, chills or shivering, severe nausea or diarrhea, decreased appetite, headache, dizziness or lightheadedness, confusion, difficulty speaking or slurred speech, cough, difficulty breathing, and fast or irregular heartbeat. Tell your doctor immediately if you develop any of these symptoms after receiving Abecma.

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 of Abecma is supported by the Risk Evaluation and Mitigation Strategy (REMS) program. For more information, please visit abecma.com or call 1-888-805-4555. You can also learn more about this therapy with this Abecma Fact Sheet.