Abecma (idecabtagene vicleucel)
An approved treatment for Multiple Myeloma.
Drug facts
The same compound appears under different names depending on the context. Here is how to identify Idecabtagene vicleucel wherever you encounter it, plus the key facts at a glance.
- Generic name
- Idecabtagene vicleucel
- Brand name
- Abecma
- Development code
- bb2121
- Drug class
- BCMA-directed CAR T cell therapy
- Manufacturer
- Bristol Myers Squibb (Celgene Corporation); developed with 2seventy bio
- How it's taken
- A single IV infusion of the patient's own engineered T cells, given once at a treatment center
Abecma (idecabtagene vicleucel) is a one-time CAR T cell therapy, made from a person's own T cells, for adults with relapsed or refractory multiple myeloma[1].
- The current label covers adults after 2 or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody[1].
- The FDA first approved Abecma on March 26, 2021, after 4 or more prior lines, and moved it to earlier use on April 4, 2024[2].
- In the KarMMa-3 trial, median progression-free survival was 13.3 months with Abecma against 4.4 months with standard regimens[1].
- Abecma carries a boxed warning for cytokine release syndrome, nerve toxicities, HLH/MAS, prolonged low blood counts and T-cell cancers[1].
- Abecma is not approved for newly diagnosed myeloma, and the FDA ended its REMS safety program in June 2025[1][3].
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Where Idecabtagene vicleucel fits
The label limits Abecma to adults with relapsed or refractory myeloma after 2 or more prior lines of therapy that included an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody[1]. Abecma is given once, on its own, after lymphodepleting chemotherapy[1]. In KarMMa-3, it was compared with standard regimens such as daratumumab, pomalidomide and dexamethasone[1].
How Idecabtagene vicleucel works
Abecma is a CAR T cell therapy, a living treatment built from the patient's own immune cells[1]. T cells are collected from the blood, and a lab adds a gene for a chimeric antigen receptor (CAR) that recognizes B-cell maturation antigen (BCMA)[1]. BCMA sits on the surface of normal and cancerous plasma cells, the cells that become myeloma[1].
The Abecma receptor uses an antibody fragment (scFv) to bind BCMA, with 4-1BB and CD3-zeta parts that switch the T cell on[1]. Once the cells bind BCMA, they multiply, release signaling proteins and kill the BCMA-carrying cells[1]. The cells are returned as a single infusion[1].
Side effects and safety
- Early death. In KarMMa-3, 18% of the Abecma arm died within 9 months of randomization against 11% on standard regimens.
- Cytokine release syndrome. Occurred in 89%, starting a median of 1 day after infusion; grade 3 or higher in 7%.
- Nerve toxicities. Occurred in 40%, most often confusion, headache, dizziness, delirium and tremor; grade 3 or 4 in under 5%.
- HLH/MAS. Occurred in 2.9%, within 10 days of infusion and alongside CRS; fatal cases occurred.
- Allergic reactions. Serious reactions, including anaphylaxis, may be caused by the DMSO in the cell bag.
- Infections. Occurred in 61%, grade 3 or 4 in 21%; fatal infections in 4.3%.
- Prolonged low blood counts. Grade 3 or 4 low neutrophils or platelets were still present at 1 month in about 4 in 10 people; median recovery took 1.9 months.
- Low antibody levels. IgG fell below 500mg/dL in 37%; the label advises IVIG when IgG is below 400mg/dL. Live vaccines are not advised until immune recovery.
- Secondary cancers. Myeloid cancers occurred in 2.2% in KarMMa-3; T-cell cancers, including CAR-positive tumors, can appear weeks after infusion.
- Daily checks for at least 7 days after infusion for CRS and nerve problems
- Stay near a healthcare facility for at least 1 week after infusion
- No driving for at least 1 week after infusion
- Blood counts before and after infusion
- Immunoglobulin (IgG) levels after treatment
- Life-long monitoring for secondary cancers
Abecma has a boxed warning, the FDA's strongest label warning, for these risks[1]:
- Cytokine release syndrome (CRS), a body-wide inflammatory reaction with fever and low blood pressure, occurred in 89% of 349 people in the KarMMa-3 and KarMMa studies[1].
- CRS was grade 3 or higher in 7%, and fatal in 0.9%[1].
- Nerve toxicities occurred in 40%, with grade 3 in 4% and grade 4 in 0.6%[1].
- HLH/MAS, a severe immune overactivation, occurred in 2.9% and can be fatal[1].
- Prolonged low blood counts were common, and some people needed a stem cell infusion to recover them[1].
- T-cell cancers have been reported after BCMA and CD19 CAR T therapies, including Abecma[1].
After 1 month, 40% still had grade 3 or 4 low neutrophils and 42% had grade 3 or 4 low platelets[1]. Infections occurred in 61%, with grade 3 or 4 infections in 21% and fatal infections in 4.3%[1]. In KarMMa-3, myeloid cancers (MDS or AML) developed in 2.2% of people treated with Abecma[1]. The label also notes grade 3 parkinsonism and myelitis in another Abecma myeloma study[1].
In KarMMa-3, 18% of people randomized to Abecma died within 9 months, against 11% on standard regimens[1]. Of those early deaths, 20 of 45 happened before the Abecma infusion, mostly from myeloma progression[1].
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Idecabtagene vicleucel
Abecma is made individually for each patient and given at a treatment center in steps[1]:
- Leukapheresis: white blood cells are collected and sent for manufacturing[1].
- Bridging therapy: most people in KarMMa-3 (85%) got other myeloma treatment while they waited[1].
- Lymphodepletion: cyclophosphamide 300mg/m2 and fludarabine 30mg/m2 by IV for 3 days[1].
- Infusion: a single IV dose of 300 to 510 million CAR-positive T cells, given 2 days after lymphodepletion ends[1].
Before the infusion, people get acetaminophen and an antihistamine, and tocilizumab must be available for CRS[1]. In KarMMa-3, the median time from cell collection to product availability was 35 days[1]. The label puts the manufacturing failure risk at 2.1% across the clinical studies, and a second manufacturing attempt may be made[1].
The current label calls for daily monitoring for at least 7 days after infusion[1]. It asks patients to stay near a healthcare facility for at least 1 week and not to drive for at least 1 week[1]. The Abecma REMS, which required certified hospitals, was eliminated by the FDA on June 26, 2025, and the current label lists no REMS[3][1].
Availability and cost
Only available as the brand-name product.
Help paying for Abecma
With private insurance, the drugmaker's copay card can lower what you pay for Abecma. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE, but charity funds often can. Of the 5 charity funds for Multiple Myeloma, 1 was open on October 26, 2026. Pick your insurance below to see which offers fit you.
- Copay help
Through the Copay Assistance Program, Cell Therapy 360 can cover out-of-pocket expenses for the Bristol Myers Squibb CAR T cell therapy product for commercially insured patients. Covers the product only, not other provider charges or treatment costs; limitations and eligibility requirements apply. Not available with Medicare, Medicaid, TRICARE, VA or any other federal or state healthcare program.
For: private insurance · source - Travel help
Cell Therapy 360 may be able to support eligible patients and a caregiver with transportation, lodging and meal assistance throughout the treatment journey. Eligibility requirements apply.
The official page does not say who qualifies. Ask the program. · source - Insurance and case manager help
Patients who enroll get a personal Patient Support Navigator. 24/7 on-call help with the program and enrollment is at 1-888-805-4555 (press 1 for patient support).
The official page does not say who qualifies. Ask the program. · source
Good to know: A treating healthcare provider at a certified treatment center enrolls the patient after Abecma is prescribed. The copay program covers out-of-pocket costs for the Abecma product only and excludes all government insurance. The page lists independent travel and housing charities that are not sponsored by Bristol Myers Squibb. The page does not name a dollar cap or a free-drug program for Abecma.
Charity funds for Multiple Myeloma
- From a charity · HealthWell FoundationMultiple Myeloma (Medicare Access) fundOpen
Pays for: Copays, premiums or other treatment costs. Medicare patients only.
Clinical trial results
KarMMa-3 (NCT03651128), called Study 1 on the label, randomized 386 adults with 2 to 4 prior lines of therapy whose myeloma was refractory to their last regimen[1][6]. Patients got Abecma or a standard regimen chosen by their doctor, in a 2 to 1 ratio[1]. About two in three people, 66%, were triple-class refractory[1].
Results from the label, at a median follow-up of 15.9 months[1]:
The label says the overall survival curves crossed at month 15, so a single survival hazard ratio is unreliable[1]. Most people in the standard arm (56%) later crossed over to Abecma[1].
KarMMa (NCT03361748), Study 2 on the label, was the single-arm study behind the 2021 approval[1][7]. Its 100 evaluated patients had a median of 6 prior lines[1]. In that study, 72% responded and 28% reached a stringent complete response[1].
Development history
Abecma is made and marketed by Celgene Corporation, a Bristol Myers Squibb company, and was developed with 2seventy bio[1][5]. Its approval history with the FDA:
- March 26, 2021: first approval, for relapsed or refractory myeloma after 4 or more prior lines including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody[2].
- April 4, 2024: approval moved to adults after 2 or more prior lines, based on KarMMa-3[2][5].
- June 26, 2025: the FDA eliminated the REMS for BCMA and CD19 CAR T therapies, including Abecma[3].
In June 2025 the label moved to at least 2 weeks near a healthcare facility and 2 weeks without driving[3]. A November 2025 label update shortened both to at least 1 week for Abecma[1]. The FDA said makers must still run 15-year follow-up studies of secondary cancers and long-term safety[3].
Explore Multiple Myeloma trials
Other Multiple Myeloma treatments
Abecma is 1 of 2 FDA-approved BCMA CAR T therapies for myeloma, alongside Carvykti (ciltacabtagene autoleucel), and no head-to-head trial has compared them. Other medicines aim at BCMA in different ways, including bispecific antibodies given repeatedly and the antibody-drug conjugate Blenrep. Abecma's label requires prior use of all 3 main drug classes: immunomodulatory drugs, proteasome inhibitors and anti-CD38 antibodies.
Common questions about Idecabtagene vicleucel
▸What is Idecabtagene vicleucel (Abecma)?
Abecma (idecabtagene vicleucel) is a one-time CAR T cell therapy, made from a person's own T cells, for adults with relapsed or refractory multiple myeloma[1]. The current label covers adults after 2 or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody[1]. The FDA first approved Abecma on March 26, 2021, after 4 or more prior lines, and moved it to earlier use on April 4, 2024[2]. In the KarMMa-3 trial, median progression-free survival was 13.3 months with Abecma against 4.4 months with standard regimens[1]. Abecma carries a boxed warning for cytokine release syndrome, nerve toxicities, HLH/MAS, prolonged low blood counts and T-cell cancers[1]. Abecma is not approved for newly diagnosed myeloma, and the FDA ended its REMS safety program in June 2025[1][3].
▸How does Idecabtagene vicleucel work?
Abecma is a CAR T cell therapy, a living treatment built from the patient's own immune cells[1]. T cells are collected from the blood, and a lab adds a gene for a chimeric antigen receptor (CAR) that recognizes B-cell maturation antigen (BCMA)[1]. BCMA sits on the surface of normal and cancerous plasma cells, the cells that become myeloma[1].
The Abecma receptor uses an antibody fragment (scFv) to bind BCMA, with 4-1BB and CD3-zeta parts that switch the T cell on[1]. Once the cells bind BCMA, they multiply, release signaling proteins and kill the BCMA-carrying cells[1]. The cells are returned as a single infusion[1].
▸What are the side effects of Idecabtagene vicleucel?
Abecma has a boxed warning, the FDA's strongest label warning, for these risks[1]: Cytokine release syndrome (CRS), a body-wide inflammatory reaction with fever and low blood pressure, occurred in 89% of 349 people in the KarMMa-3 and KarMMa studies[1]. CRS was grade 3 or higher in 7%, and fatal in 0.9%[1]. Nerve toxicities occurred in 40%, with grade 3 in 4% and grade 4 in 0.6%[1]. HLH/MAS, a severe immune overactivation, occurred in 2.9% and can be fatal[1]. Prolonged low blood counts were common, and some people needed a stem cell infusion to recover them[1]. T-cell cancers have been reported after BCMA and CD19 CAR T therapies, including Abecma[1].
After 1 month, 40% still had grade 3 or 4 low neutrophils and 42% had grade 3 or 4 low platelets[1]. Infections occurred in 61%, with grade 3 or 4 infections in 21% and fatal infections in 4.3%[1]. In KarMMa-3, myeloid cancers (MDS or AML) developed in 2.2% of people treated with Abecma[1]. The label also notes grade 3 parkinsonism and myelitis in another Abecma myeloma study[1].
In KarMMa-3, 18% of people randomized to Abecma died within 9 months, against 11% on standard regimens[1]. Of those early deaths, 20 of 45 happened before the Abecma infusion, mostly from myeloma progression[1].
▸How is Idecabtagene vicleucel taken?
Abecma is made individually for each patient and given at a treatment center in steps[1]:
- Leukapheresis: white blood cells are collected and sent for manufacturing[1].
- Bridging therapy: most people in KarMMa-3 (85%) got other myeloma treatment while they waited[1].
- Lymphodepletion: cyclophosphamide 300mg/m2 and fludarabine 30mg/m2 by IV for 3 days[1].
- Infusion: a single IV dose of 300 to 510 million CAR-positive T cells, given 2 days after lymphodepletion ends[1].
Before the infusion, people get acetaminophen and an antihistamine, and tocilizumab must be available for CRS[1]. In KarMMa-3, the median time from cell collection to product availability was 35 days[1]. The label puts the manufacturing failure risk at 2.1% across the clinical studies, and a second manufacturing attempt may be made[1].
The current label calls for daily monitoring for at least 7 days after infusion[1]. It asks patients to stay near a healthcare facility for at least 1 week and not to drive for at least 1 week[1]. The Abecma REMS, which required certified hospitals, was eliminated by the FDA on June 26, 2025, and the current label lists no REMS[3][1].
▸Is Idecabtagene vicleucel FDA approved?
Yes, Idecabtagene vicleucel (Abecma) is FDA approved (2021) for the treatment of Multiple Myeloma.
▸How long does Abecma take to work?
In the KarMMa study, the median time to first response was 30 days after the Abecma infusion[1].
Wait before infusion: In KarMMa-3, the median time from cell collection to product availability was 35 days[1].
Durability: In KarMMa-3, the median duration of response was 14.8 months for people with at least a partial response[1].
Source: Abecma prescribing information (DailyMed)
▸Does Abecma still have a REMS program?
No, the FDA eliminated the Abecma REMS on June 26, 2025, and the current label lists no REMS[3][1].
Nearby stay: The current label asks patients to stay near a healthcare facility for at least 1 week after infusion[1].
Driving: The label advises no driving for at least 1 week after infusion[1].
Monitoring: Daily checks for at least 7 days after infusion remain on the label[1].
Source: FDA safety communication, June 26, 2025; Abecma prescribing information (DailyMed)
▸What is the difference between Abecma and Carvykti?
Both are one-time BCMA CAR T therapies made from a patient's own T cells, and no head-to-head trial has compared them[1].
Abecma label: Adults after 2 or more prior lines, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody[1].
Carvykti label: Adults after at least 1 prior line, including a proteasome inhibitor and an immunomodulatory agent, who are refractory to lenalidomide[4].
Receptor: The Abecma receptor uses a single antibody fragment to bind BCMA[1].
Source: Abecma prescribing information (DailyMed); Carvykti prescribing information (DailyMed)
▸Can Abecma cause another cancer?
Yes, the Abecma boxed warning includes T-cell cancers reported after BCMA and CD19 CAR T therapies, including Abecma[1].
Trial rate: In KarMMa-3, myeloid cancers (4 MDS and 1 AML) occurred in 2.2% of Abecma-treated patients[1].
Timing: T-cell cancers may appear as soon as weeks after infusion[1].
Reporting: The label asks that a secondary cancer be reported to Bristol-Myers Squibb at 1-888-805-4555[1].
Source: Abecma prescribing information (DailyMed)
▸Does insurance cover Abecma, and is there cost help?
Coverage depends on the plan, and the price is not stated on the label.
Copay help: Cell Therapy 360's Copay Assistance Program can cover out-of-pocket costs for the CAR T product for commercially insured patients, with limits[8].
Not eligible: The copay program excludes Medicare, Medicaid, TRICARE, VA and other government plans[8].
Travel: Cell Therapy 360 may help eligible patients and a caregiver with transportation, lodging and meals[8].
Source: Cell Therapy 360 patient page (Bristol Myers Squibb)
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- U.S. National Library of Medicine, DailyMed (Celgene Corporation, a Bristol-Myers Squibb company) · 2025-11. ABECMA (idecabtagene vicleucel) suspension for intravenous infusion, full prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b90c1fe7-f5cc-464e-958a-af36e9c26d7c
- U.S. Food and Drug Administration, Center for Biologics Evaluation and Research · 2025-12-04. ABECMA (BLA 125736): indications, approval letters and supporting documents. https://www.fda.gov/vaccines-blood-biologics/abecma
- U.S. Food and Drug Administration · 2025-06-26. FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies. https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-eliminates-risk-evaluation-and-mitigation-strategies-rems-autologous-chimeric-antigen-receptor
- U.S. National Library of Medicine, DailyMed (Janssen Biotech, Inc.) · 2026-08. CARVYKTI (ciltacabtagene autoleucel) suspension for intravenous infusion, full prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7d040b91-3fb8-41db-ba7f-60a36f06e2c2
- Bristol Myers Squibb · 2024-04-05. U.S. FDA Approves Bristol Myers Squibb and 2seventy bio's Abecma for Triple-Class Exposed Relapsed or Refractory Multiple Myeloma After Two Prior Lines of Therapy. https://news.bms.com/news/details/2024/U.S.-FDA-Approves-Bristol-Myers-Squibb-and-2seventy-bios-Abecma-for-Triple-Class-Exposed-Relapsed-or-Refractory-Multiple-Myeloma-After-Two-Prior-Lines-of-Therapy/default.aspx
- ClinicalTrials.gov · 2026-11. Efficacy and Safety Study of bb2121 Versus Standard Regimens in Subjects With Relapsed and Refractory Multiple Myeloma (KarMMa-3). https://clinicaltrials.gov/study/NCT03651128
- ClinicalTrials.gov · 2026-11. Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma (KarMMa). https://clinicaltrials.gov/study/NCT03361748
- Bristol Myers Squibb · 2026-11. Patient and Caregiver Support, Cell Therapy 360. https://www.celltherapy360.com/patients