Abecma idecabtagene vicleucel 300000000 1/1 Suspension, 1 suspension
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Antineoplastic cell and gene therapy class.
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🩺 Clinical
- Abecma is made from your own immune cells — specifically your T cells. Doctors collect them, genetically engineer them in a lab to recognize and destroy your myeloma cells, and the...
- What exactly is Abecma and how is it different from regular chemotherapy?
- The most serious one is called cytokine release syndrome, or CRS — it happened in almost 9 out of 10 patients in studies. It can feel like a severe flu with high fever, low blood p...
- What are the most important side effects I should know about?
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UNII YOW8V9698H
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
2 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
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| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · Q2055 | $567,977.780 / Q2055 unit | — |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Abecma 300000000 1this 59572-0515-02 | Celgene | 1 suspension | — | — | FDA listed | — |
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⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.
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- Biologic patent
- A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
- Reference-product exclusivity
- A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
- Interchangeable exclusivity
- The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
- Earliest biosimilar (LOE)
- The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.
Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Mar 3, 2033 |
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🔬 Reported adverse events (FAERS)
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 59572-0515-01 | 1 SUSPENSION in 1 BAG (59572-515-01) | 2021-03-26 | Active |
| 59572-0515-02 You're viewing this | 1 SUSPENSION in 1 BAG (59572-515-02) | 2021-03-26 | Active |
| 59572-0515-03 | 1 SUSPENSION in 1 BAG (59572-515-03) | 2021-03-26 | Active |
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🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full FDA label FDA SPL
🚨 Boxed Warning ▾
WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, PROLONGED CYTOPENIA, AND SECONDARY HEMATOLOGICAL MALIGNANCIES • Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with ABECMA. Do not administer ABECMA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids [see Dosage and Administration (2.2 , 2.3) , Warnings and Precautions (5.2) ] . • Neurologic toxicities, which may be severe or life-threatening, occurred following treatment with ABECMA, including concurrently with CRS, after CRS resolution, or in the absence of CRS.
Monitor for neurologic events after treatment with ABECMA. Provide supportive care and/or corticosteroids as needed [see Dosage and Administration (2.2 , 2.3) and Warnings and Precautions (5.3) ] . • 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 [see Warnings and Precautions (5.4) ] . • Prolonged Cytopenia with bleeding and infection, including fatal outcomes following stem cell transplantation for hematopoietic recovery, occurred following treatment with ABECMA [see Warnings and Precautions (5.7) ] . • T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including ABECMA [see Warnings and Precautions (5.9) ] .
WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, PROLONGED CYTOPENIA, AND SECONDARY HEMATOLOGICAL MALIGNANCIES See full prescribing information for complete boxed warning. • Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with ABECMA. Do not administer ABECMA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
( 2.2 , 2.3 , 5.2 ) • Neurologic toxicities, which may be severe or life-threatening, occurred following treatment with ABECMA, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with ABECMA. Provide supportive care and/or corticosteroids as needed.
( 2.2 , 2.3 , 5.3 ) • 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. ( 5.4 ) • Prolonged Cytopenia with bleeding and infection, including fatal outcomes following stem cell transplantation for hematopoietic recovery, occurred following treatment with ABECMA.
( 5.7 ) • T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including ABECMA. ( 5.9 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE ABECMA is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. ABECMA is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION For autologous use only. For intravenous use only. • Do NOT use a leukodepleting filter. ( 2.2 ) • Administer a lymphodepleting chemotherapy regimen of cyclophosphamide and fludarabine before infusion of ABECMA.
( 2.2 ) • Confirm the patient's identity prior to infusion. ( 2.2 ) • Premedicate with acetaminophen and an H 1 -antihistamine. ( 2.2 ) • Avoid prophylactic use of dexamethasone or other systemic corticosteroids.
( 2.2 ) • Confirm availability of tocilizumab prior to infusion. ( 2.2 , 5.2 ) • Dosing of ABECMA is based on the number of chimeric antigen receptor (CAR)-positive T cells. ( 2.1 ) • The recommended dose range is 300 to 510 × 10 6 CAR-positive T cells.
( 2.1 )
2.1Dose For autologous use only. For intravenous use only. ABECMA is provided as a single dose for infusion containing a suspension of chimeric antigen receptor (CAR)-positive T cells in one or more infusion bags. The recommended dose range is 300 to 510 × 10 6 CAR-positive T cells. See the accompanying Release for Infusion Certificate (RFI Certificate) for additional information pertaining to dose [see How Supplied/Storage and Handling (16) ] .
2.2Administration ABECMA is for autologous use only. The patient's identity must match the patient identifiers on the ABECMA cassette(s) and infusion bag(s). Do not infuse ABECMA if the information on the patient-specific label(s) does not match the intended patient.
Preparing Patient for ABECMA Infusion Confirm the availability of ABECMA prior to starting the lymphodepleting chemotherapy regimen. Pretreatment Administer the lymphodepleting chemotherapy regimen: cyclophosphamide 300 mg/m 2 intravenously (IV) and fludarabine 30 mg/m 2 IV for three days. See the prescribing information of cyclophosphamide and fludarabine for information on dose adjustment in renal impairment.
Administer ABECMA two days after completion of lymphodepleting chemotherapy. Delay the infusion of ABECMA up to seven days if a patient has 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 [see Warnings and Precautions (5.6) ] . Premedication Administer acetaminophen (650 mg orally) and diphenhydramine (12.5 mg IV or 25 to 50 mg orally, or another H 1 -antihistamine) approximately 30 to 60 minutes before infusion of ABECMA.
Avoid prophylactic use of dexamethasone or other systemic corticosteroids, as the use may interfere with the activity of ABECMA. Receipt of ABECMA • ABECMA is shipped directly to the cell laboratory or clinical pharmacy associated with the infusion center in the vapor phase of a liquid nitrogen shipper. • Confirm the patient's identity with the patient identifiers on the shipper. • If the patient is not expected to be ready for same-day administration before the shipper expires and the infusion site is qualified for onsite storage, transfer ABECMA to onsite vapor phase of liquid nitrogen storage. • If the patient is not expected to be ready for same-day administration before the shipper expires and the infusion site is not qualified for onsite storage, contact Bristol-Myers Squibb at 1-888-805-4555 to arrange for return shipment.
Preparation of ABECMA for Infusion 1. Coordinate the timing of ABECMA thaw and infusion. Confirm the infusion time in advance and adjust the start time of the thaw of ABECMA so that it will be available for infusion when the patient is ready.
2. Prior to thawing the product, confirm that tocilizumab and emergency equipment are available prior to the infusion and during the recovery period. 3.
An ABECMA dose may be contained in one or more patient-specific infusion bag(s). The infusion bag is overwrapped with a transparent plastic sleeve that is folded to the back of the infusion bag. Verify the number of bags received for the indicated dose of ABECMA prior to preparation of ABECMA for infusion.…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS A single dose of ABECMA contains a cell suspension of 300 to 510 × 10 6 chimeric antigen receptor (CAR)-positive T cells in one or more infusion bags [see How Supplied/Storage and Handling (16) ] . • A single dose of ABECMA contains a cell suspension of 300 to 510 × 10 6 CAR-positive T cells in one or more infusion bags. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Hypersensitivity Reactions : Monitor for hypersensitivity reactions during infusion. ( 5.5 ) • Infections : Monitor patients for signs and symptoms of infection; treat appropriately. ( 5.6 ) • Prolonged Cytopenias : Patients may exhibit prolonged Grade 3 or higher cytopenias following ABECMA infusion.
Monitor blood counts prior to and after ABECMA infusion. ( 5.7 ) • Hypogammaglobulinemia : Monitor and consider immunoglobulin replacement therapy. ( 5.8 ) • Secondary Malignancies : T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including ABECMA.
In the event that a secondary malignancy occurs after treatment with ABECMA, contact Bristol-Myers Squibb at 1-888-805-4555. ( 5.9 )
5.1Early Death In Study 1, a randomized (2:1), controlled trial, a higher proportion of patients experienced death within nine months after randomization in the ABECMA arm (45/254; 18%) compared to the standard regimens arm (15/132; 11%) [see Clinical Studies (14) ] . Early deaths occurred in 8% (20/254) and 0% prior to ABECMA infusion and standard regimen administration, respectively, and 10% (25/254) and 11% (15/132) after ABECMA infusion and standard regimen administration, respectively. Out of the 20 deaths that occurred prior to ABECMA infusion, 15 occurred from disease progression, 3 occurred from adverse events and 2 occurred from unknown causes.
Out of the 25 deaths that occurred after ABECMA infusion, 10 occurred from disease progression, 11 occurred from adverse events, and 4 occurred from unknown causes.
5.2Cytokine Release Syndrome (CRS) CRS, including fatal or life-threatening reactions, occurred following treatment with ABECMA. Among patients receiving ABECMA for relapsed or refractory multiple myeloma in Study 1 and Study 2 (N=349), CRS occurred in 89% (310/349), including ≥ Grade 3 CRS (Lee grading system) in 7% (23/349) of patients and Grade 5 CRS in 0.9% (3/349) of patients. The median time-to-onset of CRS, any grade, was 1 day (range: 1 to 27 days), and the median duration of CRS was 5 days (range: 1 to 63 days).
In the pooled studies, the rate of ≥ Grade 3 CRS was 10% (7/71) for patients treated in dose range of 460 to 510 × 10 6 CAR-positive T cells and 5.4% (13/241) for patients treated in dose range of 300 to 460 × 10 6 CAR-positive T cells. The most common manifestations of CRS (≥10%) included pyrexia (87%), hypotension (30%), tachycardia (26%), chills (19%), and hypoxia (16%). Grade 3 or higher events that may be associated with CRS include hypotension, hypoxia, hyperbilirubinemia, hypofibrinogenemia, ARDS, atrial fibrillation, hepatocellular injury, metabolic acidosis, pulmonary edema, coagulopathy, renal failure, multiple organ dysfunction syndrome and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS) [see Adverse Reactions (6.1) ] .
Identify CRS based on clinical presentation. Evaluate for and treat other causes of fever, hypoxia, and hypotension. CRS has been reported to be associated with findings of HLH/MAS, and the physiology of the syndromes may overlap.
HLH/MAS is a potentially life-threatening condition. In patients with progressive symptoms of CRS or refractory CRS despite treatment, evaluate for evidence of HLH/MAS. Please see Section 5.4 ; Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome.
Of the 349 patients who received ABECMA in clinical trials, 226 (65%) patients received tocilizumab; 39% (135/349) received a single dose, while 26% (91/349) received more than 1 dose of tocilizumab. Overall, 24% (82/349) of patients received at least 1 dose of corticosteroids for treatment of CRS. Almost all patients who received corticosteroids for CRS also received tocilizumab.
For patients treated in dose range of 460 to 510 × 10 6 CAR-positive T cells, 76% (54/71) of patients received tocilizumab and 35% (25/71) received at least 1 dose of…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in the labeling: • Early Death [see Warnings and Precautions (5.1) , Clinical Studies (14) ] • Cytokine Release Syndrome [see Warnings and Precautions (5.2) ] • Neurologic Toxicities [see Warnings and Precautions (5.3) ] • Hemophagocytic Lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS) [see Warnings and Precautions (5.4) ] • Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] • Infections [see Warnings and Precautions (5.6) ] • Prolonged Cytopenias [see Warnings and Precautions (5.7) ] • Hypogammaglobulinemia [see Warnings and Precautions (5.8) ] The most common nonlaboratory adverse reactions (incidence ≥20%) include pyrexia, CRS, hypogammaglobulinemia, infections–pathogen unspecified, musculoskeletal pain, fatigue, febrile neutropenia, hypotension, tachycardia, diarrhea, nausea, headache, chills, upper respiratory tract infection, encephalopathy, edema, dyspnea and viral infections.
( 6.1 ) The most common Grade 3 or 4 laboratory adverse reactions (incidence ≥50%) include leukocyte count decreased, neutrophil count decreased, lymphocyte count decreased, platelet count decreased, and hemoglobin decreased. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety data described in the WARNINGS and PRECAUTIONS section reflect exposure to ABECMA in 349 patients with relapsed or refractory multiple myeloma: one randomized, open-label study with 222 patients in Study 1 and one single-arm, open-label study with 127 patients in Study 2.
Study 1 The safety data described in this section reflect the exposure to ABECMA in Study 1, in which 222 patients with relapsed or refractory multiple myeloma received ABECMA across a dose range of 175 to 529 × 10 6 CAR-positive T cells (median dose: 445 × 10 6 CAR-positive T cells) [see Clinical Studies (14) ] . Patients with a history of CNS disease or requiring ongoing treatment with chronic immunosuppression were excluded. The median age of the safety population was 63 years (range: 30 to 81 years); 43% were 65 years or older, and 63% were men.
The Eastern Cooperative Oncology Group (ECOG) performance status at baseline was 0 in 47%, 1 in 51%, 2 in 1.4% and 3 in 0.5% of patients. Four (1.8%) patients treated with ABECMA had creatinine clearance <45 mL/min. For details about the study population, [see Clinical Studies (14) ] .
The most common (≥10%) Grade 3 or 4 nonlaboratory adverse reactions was febrile neutropenia (51%) and any infections (16%). The most common nonlaboratory adverse reactions (incidence ≥20%) included CRS, pyrexia, any infection, febrile neutropenia, hypogammaglobulinemia, musculoskeletal pain, hypotension, infections–pathogen unspecified, fatigue, tachycardia, diarrhea, nausea, headache, encephalopathy, dyspnea and edema. Serious adverse reactions occurred in 43% of patients.
The most common nonlaboratory (≥5%) serious adverse reactions included infections–pathogen unspecified (10%), pneumonia (9%), viral infections (8%), encephalopathy (6%), pyrexia (6%) and sepsis (5%). Fatal adverse reactions occurred in 9%. Table 3 summarizes the adverse reactions that occurred in at least 10% of patients treated with ABECMA.
Table 4 describes the most common Grade 3 or 4 laboratory abnormalities. Table 3: Adverse Reactions Observed in at Least 10% of Patients Treated in Study 1 CAR=chimeric antigen receptor. * Represents multiple related terms. a Coagulopathy includes activated partial thromboplastin time prolonged, blood fibrinogen decreased, coagulopathy, disseminated intravascular coagulati…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Drug/Laboratory Test Interactions HIV and the lentivirus used to make ABECMA have limited, short spans of identical genetic material (RNA). Therefore, some commercial HIV nucleic acid tests may yield false-positive results in patients who have received ABECMA.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no available data with ABECMA use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with ABECMA to assess whether it can cause fetal harm when administered to a pregnant woman. It is not known if ABECMA has the potential to be transferred to the fetus.
Based on the mechanism of action, if the transduced cells cross the placenta, they may cause fetal toxicity, including plasma cell aplasia or hypogammaglobulinemia. Therefore, ABECMA is not recommended for women who are pregnant, and pregnancy after ABECMA infusion should be discussed with the treating physician. Assess immunoglobulin levels in newborns of mothers treated with ABECMA.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. The estimated background risk in the U.S. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.
8.2Lactation Risk Summary There is no information regarding the presence of ABECMA in human milk, the effect on the breastfed infant, and the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ABECMA and any potential adverse effects on the breastfed infant from ABECMA or from the underlying maternal condition.
8.3Females and Males of Reproductive Potential Pregnancy Testing Pregnancy status of sexually active females with reproductive potential should be verified via pregnancy testing prior to starting treatment with ABECMA. Contraception See the prescribing information for fludarabine and cyclophosphamide for information on the need for effective contraception in patients who receive the lymphodepleting chemotherapy. There are insufficient exposure data to provide a recommendation concerning duration of contraception following treatment with ABECMA.
Infertility There are no data on the effect of ABECMA on fertility.
8.4Pediatric Use The safety and efficacy of ABECMA in pediatric patients have not been established.
8.5Geriatric Use In the clinical trials of ABECMA, 141 (40%) of the 349 patients were 65 years of age or older and 16/349 (4.6%) patients were 75 years of age or older. In Study 2, all five cases of Grade 3 neurotoxicity occurred in patients ≥65 years of age (66 to 74 years). No clinically important differences in effectiveness of ABECMA were observed between these patients and patients younger than 65 years of age.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no available data with ABECMA use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with ABECMA to assess whether it can cause fetal harm when administered to a pregnant woman. It is not known if ABECMA has the potential to be transferred to the fetus.
Based on the mechanism of action, if the transduced cells cross the placenta, they may cause fetal toxicity, including plasma cell aplasia or hypogammaglobulinemia. Therefore, ABECMA is not recommended for women who are pregnant, and pregnancy after ABECMA infusion should be discussed with the treating physician. Assess immunoglobulin levels in newborns of mothers treated with ABECMA.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. The estimated background risk in the U.S. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and efficacy of ABECMA in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use In the clinical trials of ABECMA, 141 (40%) of the 349 patients were 65 years of age or older and 16/349 (4.6%) patients were 75 years of age or older. In Study 2, all five cases of Grade 3 neurotoxicity occurred in patients ≥65 years of age (66 to 74 years). No clinically important differences in effectiveness of ABECMA were observed between these patients and patients younger than 65 years of age.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action ABECMA is a chimeric antigen receptor (CAR)-positive T cell therapy targeting B-cell maturation antigen (BCMA), which is expressed on the surface of normal and malignant plasma cells. The CAR construct includes an anti-BCMA scFv-targeting domain for antigen specificity, a transmembrane domain, a CD3-zeta T cell activation domain, and a 4-1BB costimulatory domain. Antigen-specific activation of ABECMA results in CAR-positive T cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells.
12.2Pharmacodynamics Following ABECMA infusion, pharmacodynamic responses of CAR activation and anti-tumor efficacy were evaluated. Peak elevation of plasma cytokines, chemokines, and soluble immune mediators occurred within 14 days of ABECMA infusion and returned to baseline levels within one month. Rapid decreases in tumor markers associated with clinical response, including serum levels of soluble BCMA, and bone marrow CD138+ cells, as well as minimal residual disease (MRD) negative responses, were observed within the first month following ABECMA infusion.
12.3Pharmacokinetics Following ABECMA infusion, the CAR-positive T cells proliferate and undergo rapid multi-log expansion followed by a bi-exponential decline. The median time of maximal expansion in peripheral blood (T max ) occurred 11 days after infusion. ABECMA can persist in peripheral blood for up to 1 year post-infusion.
A summary of T max , AUC 0-28days , and C max from Study 1 and Study 2 is provided in Table 7. Table 7: Pharmacokinetic Parameters of ABECMA in Patients with Relapsed/Refractory Multiple Myeloma AUC 0-28days =area under the curve of the transgene level from time of dose to 28 days post-infusion; C max =the maximum transgene level; ddPCR=droplet digital polymerase chain reaction; qPCR=quantitative polymerase chain reaction; PK=pharmacokinetics; T max =time of maximum observed transgene level. a The PK parameters of Study 1 were determined by time course of transgene copies per microgram of DNA extracted from whole blood as quantified by droplet digital PCR (ddPCR). b The PK parameters of Study 2 were determined by time course of transgene copies per microgram of DNA extracted from CD3+ sorted cells as quantified by quantitative polymerase chain reaction (qPCR).
Note: The PK parameters should not be directly compared between Study 1 and Study 2 due to different primary PK assays used in these two studies. Pharmacokinetic Parameter Summary Statistic Study 1 Total [300 to 510 × 10 6 ] CAR-Positive T Cells (Quantified by ddPCR) a Study 2 Total [300 to 460 × 10 6 ] CAR-Positive T Cells (Quantified by qPCR) b T max (days) Median (Range) 11 (4-31) N=207 11 (7-28) N=99 C max (copies/mcg) Geometric mean (geometric CV%) 117,557 (215) N=207 256,333 (165) N=99 AUC 0-28days (days* copies/mcg) Geometric mean (geometric CV%) 1,098,862 (228) N=205 3,088,455 (190) N=98 ABECMA transgene levels were positively associated with objective tumor response (partial response or better).
Among patients who received ABECMA in Study 1, the median C max levels in responders (N=172) were approximately 6.5-fold higher compared to the corresponding levels in non-responders (N=35). Median AUC 0-28days in responders (N=172) was approximately 6.1-fold higher than non-responders (N=33). Among patients who received ABECMA in Study 2, the median C max levels in responders (N=72) were approximately 4.6-fold higher than the corresponding levels in non-responders (N=27).
Median AUC 0-28days in responders (N=72) was approximately 5.6-fold higher than non-responders (N=26). Tocilizumab or Siltuximab and Corticosteroid Use Some patients required tocilizumab or siltuximab and/or corticosteroid for the management of CRS. ABECMA can continue to expand and persist following tocilizumab or siltuximab or corticosteroid administration [see Warnings and Precautions (5.2) ] .
In Study 2, patients with CRS treated with tocilizumab h…
🧬 Mechanism of Action ▾
12.1Mechanism of Action ABECMA is a chimeric antigen receptor (CAR)-positive T cell therapy targeting B-cell maturation antigen (BCMA), which is expressed on the surface of normal and malignant plasma cells. The CAR construct includes an anti-BCMA scFv-targeting domain for antigen specificity, a transmembrane domain, a CD3-zeta T cell activation domain, and a 4-1BB costimulatory domain. Antigen-specific activation of ABECMA results in CAR-positive T cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING ABECMA is supplied in one or more infusion bag(s) (see below) containing a frozen suspension of genetically modified autologous T cells in 5% DMSO. Each infusion bag of ABECMA is overwrapped with a transparent plastic sleeve that is folded to the back of the infusion bag and individually packed in a metal cassette. ABECMA is stored in the vapor phase of liquid nitrogen and supplied in a liquid nitrogen dry vapor shipper.
An RFI Certificate is affixed inside the shipper. • 50 mL infusion bag and metal cassette (NDC 59572-515-01) • 250 mL infusion bag and metal cassette (NDC 59572-515-02) • 500 mL infusion bag and metal cassette (NDC 59572-515-03) Match the identity of the patient with the patient identifiers on the cassette(s) and infusion bag(s) upon receipt. Store ABECMA frozen in the vapor phase of liquid nitrogen (less than or equal to minus 130°C). Thaw ABECMA prior to infusion [see Dosage and Administration (2.2) ] .
📦 Storage and Handling ▾
Store ABECMA frozen in the vapor phase of liquid nitrogen (less than or equal to minus 130°C). Thaw ABECMA prior to infusion [see Dosage and Administration (2.2) ] .
📋 Description ▾
11 DESCRIPTION ABECMA is a BCMA-directed genetically modified autologous T cell immunotherapy product consisting of a patient's own T cells that are harvested and genetically modified ex vivo through transduction with an anti-BCMA02 chimeric antigen receptor (CAR) lentiviral vector (LVV). Autologous T cells transduced with the anti-BCMA02 CAR LVV express the anti-BCMA CAR on the T cell surface. The CAR is comprised of a murine extracellular single-chain variable fragment (scFv) specific for recognizing B cell maturation antigen (BCMA) followed by a human CD8α hinge and transmembrane domain fused to the T cell cytoplasmic signaling domains of CD137 (4-1BB) and CD3ζ chain, in tandem.
Binding of ABECMA to BCMA-expressing target cells leads to signaling initiated by CD3ζ and 4-1BB domains, and subsequent CAR-positive T cell activation. Antigen-specific activation of ABECMA results in CAR-positive T cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells. ABECMA is prepared from the patient's peripheral blood mononuclear cells (PBMCs), which are obtained via a standard leukapheresis procedure.
The mononuclear cells are enriched for T cells, through activation with anti-CD3 and anti-CD28 antibodies in the presence of IL-2, which are then transduced with the replication-incompetent lentiviral vector containing the anti-BCMA CAR transgene. The transduced T cells are expanded in cell culture, washed, formulated into a suspension, and cryopreserved. The product must pass a sterility test before release for shipping as a frozen suspension in one or more patient-specific infusion bag(s).
The product is thawed prior to infusion back into the patient [see Dosage and Administration (2.3) and How Supplied/Storage and Handling (16) ] . The ABECMA formulation contains 50% Plasma-Lyte A and 50% CryoStor ® CS10, resulting in a final DMSO concentration of 5%.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Advise patients that the risk of manufacturing failure is 2.1% [8/384 in the clinical studies]. In case of a manufacturing failure, a second manufacturing of ABECMA may be attempted.
In addition, while the patient awaits the product, additional anticancer treatment (not the lymphodepletion) may be necessary and may increase the risk of adverse events during the pre-infusion period, which could delay or prevent the administration of ABECMA. Inform patients of the risk of early death: In a clinical study, a higher proportion of patients experienced death within the first nine months from randomization in the ABECMA arm compared to the standard regimens arm. This higher rate of early death was mainly observed before receiving ABECMA with the main reason being progression of multiple myeloma.
There was also an increase in the rate of death from adverse events after ABECMA. Advise patients to seek immediate attention for any of the following: • Cytokine Release Syndrome (CRS): Signs or symptoms associated with CRS, including fever, hypotension, tachycardia, chills, hypoxia, headache, and fatigue [see Dosage and Administration (2.3) , Warnings and Precautions (5.2) , and Adverse Reactions (6.1) ] . • Neurologic Toxicities: Signs or symptoms associated with neurologic events, including encephalopathy, confusion, seizures, tremor, aphasia, delirium, and somnolence [see Dosage and Administration (2.3) , Warnings and Precautions (5.3) , and Adverse Reactions (6.1) ] . • Infections: Signs or symptoms associated with infection [see Warnings and Precautions (5.6) and Adverse Reactions (6.1) ] . • Prolonged Cytopenias: Signs or symptoms associated with bone marrow suppression, including neutropenia, anemia, thrombocytopenia, or febrile neutropenia [see Warnings and Precautions (5.7) and Adverse Reactions (6.1) ] . • Secondary malignancies: Secondary malignancies, including T cell malignancies, have occurred [see Boxed Warning , Warnings and Precautions (5.9) , Adverse Reactions (6.3) ] .
Advise patients for the need to: • Contact Bristol-Myers Squibb at 1-888-805-4555 if they are diagnosed with a secondary malignancy [see Warnings and Precautions (5.9) ] . • Have periodic monitoring of blood counts before and after ABECMA infusion [see Warnings and Precautions (5.7) ] . • Avoid driving for at least one week.
💬 Medication Guide ▾
MEDICATION GUIDE ABECMA ® (uh-BEK-muh) (idecabtagene vicleucel) This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: November 2025 Read this Medication Guide before you start your ABECMA treatment.
The more you know about your treatment, the more active you can be in your care. Talk with your healthcare provider if you have questions about your health condition or treatment. Reading this Medication Guide does not take the place of talking with your healthcare provider about your treatment.
What is the most important information I should know about ABECMA? ABECMA may cause side effects that are life-threatening and can lead to death. Call your healthcare provider or get emergency help right away if you get any of the following: • difficulty breathing • fever (100.4°F/38°C or higher) • chills/shivering • confusion • dizziness or lightheadedness • shaking or twitching (tremor) • fast or irregular heartbeat • severe fatigue • severe nausea, vomiting, diarrhea It is 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. What is ABECMA? ABECMA is for the treatment of multiple myeloma in patients who have received at least two 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. 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).
Your blood cells will be sent to a manufacturing center to make your ABECMA. Based on clinical trial experience, it takes about four weeks from the time your cells are received at the manufacturing site and are available to be shipped back to your healthcare provider, but the time may vary. Before you get ABECMA, your healthcare provider will give you chemotherapy for three days to prepare your body.
When your ABECMA is ready, your healthcare provider will give ABECMA to you through a catheter (tube) placed into your vein (intravenous infusion). Your dose of ABECMA may be given in one or more infusion bags. The infusion usually takes up to 30 minutes for each infusion bag.
You will be monitored daily for at least seven days after the infusion. You should plan to stay close to a healthcare facility for at least one week 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.
What should I avoid after receiving ABECMA? • Avoid driving for at least one week after you get ABECMA. • Do not donate blood, organs, tissues, or cells for transplantation. What are the possible or reasonably likely side effects of ABECMA? The most common side effects of ABECMA are: • fatigue • fever (100.4°F/38°C or higher) • chills/shivering • severe nausea or diarrhea • decreased appetite • headache • dizziness/lightheadedness • confusion • difficulty speaking or slurred speech • cough • difficulty breathing • fast or irregular heartbeat In a study comparing ABECMA to standard regimen, a higher proportion of patients experienced death within the first nine months from randomization in the ABECMA arm compared to the standard regimens arm.
This higher rate of early death was mainly observed before receiving ABECMA with the main reason being progression of multiple myeloma. There was also an increase in the rate of death from adverse events after ABECMA. ABECMA can cause a very common side effect called cytokine release syndrome or CRS, which can be severe or fatal.
Symptoms of CRS include fever, difficulty breathing, dizziness or light-headedness, nausea, headache, fast heartbeat, low blood pressure, or fatigue. Tell your healthcare provider right away if you develop fever or any…