Abecma

Multiple myeloma — relapsed or refractory, after four or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody

Lymphodepleting chemotherapy: Cyclophosphamide 300 mg/m² IV + fludarabine 30 mg/m² IV daily for 3 days, completed 2 days before infusion
Abecma infusion: 300-460 × 10⁶ CAR-positive T cells as single IV infusion
Pre-medication: Acetaminophen 650 mg PO and diphenhydramine 12.5 mg IV or PO approximately 30-60 min before
Do NOT use leukocyte-depleting filter

Cell suspension for IV infusion; patient-specific single infusion bag containing 300-460 × 10⁶ CAR-positive T cells in approximately 10-70 mL

None listed.

• CRS: 84% (5% Grade ≥3). Median onset: Day 1 (range 1-12). Median duration: 5 days. Manage with tocilizumab ± corticosteroids. ICU admission in 14% of patients.
• Neurologic Toxicity: 28% (4% Grade ≥3). Including tremor, confusional state, encephalopathy, aphasia. Median onset: 2 days.
• HLH/MAS: 4% (3% Grade ≥3). Can overlap with CRS.
• Prolonged Cytopenias: Grade 3-4 not resolved by Day 30: neutropenia (31%), thrombocytopenia (28%), anemia (10%).
• Infections: 69% (23% Grade ≥3). Including bacterial, viral, and fungal infections. Screen for HIV, HBV, HCV.
• Hypogammaglobulinemia: 21%. Monitor immunoglobulin levels.
• Secondary Malignancies: T-cell malignancies reported.

CRS (84%), neutropenia (89%), anemia (60%), thrombocytopenia (52%), infections (69%), fatigue (40%), musculoskeletal pain (36%), nausea (28%), diarrhea (25%), encephalopathy/confusional state (18%), headache (16%), febrile neutropenia (16%), hypogammaglobulinemia (21%)

Grade 3+ CRS in 5% (median onset Day 1). Grade 3+ neurotoxicity in 3%. Prolonged cytopenias not resolved by Day 30: neutropenia (41%), thrombocytopenia (39%). Hypogammaglobulinemia in 21%.

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

Grade 3+ CRS in 5% (median onset Day 1). Grade 3+ neurotoxicity in 3%. Prolonged cytopenias not resolved by Day 30: neutropenia (41%), thrombocytopenia (39%). Hypogammaglobulinemia in 21%.

Consult the complete prescribing information for drug interactions, including effects on CYP enzymes, transporters, and concomitant medications that may require dose adjustments or monitoring.

Consult the full prescribing information for pregnancy-related considerations.

Refer to prescribing information for lactation guidance.

Pediatric safety and efficacy information is detailed in the full label.

Dose modifications for organ impairment are specified in the complete prescribing information.

Idecabtagene vicleucel is a BCMA-directed genetically modified autologous T-cell immunotherapy. Patient T cells are collected via leukapheresis and genetically modified ex vivo with a lentiviral vector encoding a chimeric antigen receptor (CAR) comprising an anti-BCMA single-chain variable fragment (scFv) linked to a 4-1BB costimulatory domain and CD3-zeta signaling domain. Upon binding BCMA on myeloma cell surfaces, the CAR T cells activate, proliferate, and eliminate BCMA-expressing cells.

Peak CAR T-cell expansion: median 11-13 days post-infusion. CAR T cells detectable in blood for 6+ months. No traditional PK parameters apply (cell-based therapy). Persistence correlated with response duration.

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

• KarMMa — Idecabtagene vicleucel in relapsed/refractory MM after ≥3 prior regimens. Phase II, n=128.
  🔬 NCT03361748 ↗ 📄 Primary Publication ↗

Abecma has FDA-approved indications across the following cancer types covered on PipelineEvidence: