🧬 What Is Abecma?
Abecma is an autologous chimeric antigen receptor (CAR) T-cell therapy. It involves modifying a patient’s own T-cells to express a receptor targeting B-cell maturation antigen (BCMA), a protein highly expressed on multiple myeloma cells. These engineered T-cells are then infused back into the patient to recognize and destroy cancerous cells.U.S. Food and Drug Administration+1Drugs.com+1
🩺 Indications
Abecma is approved for adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including:Comprehensive Cancer Information+3U.S. Food and Drug Administration+3WSJ+3
- An immunomodulatory agent
- A proteasome inhibitor
- An anti-CD38 monoclonal antibodyU.S. Food and Drug Administration+4U.S. Food and Drug Administration+4WSJ+4U.S. Food and Drug Administration+4WSJ+4Comprehensive Cancer Information+4PressReleaseInvestorRelations+5Comprehensive Cancer Information+5WSJ+5
This approval was expanded in April 2024, allowing its use earlier in the treatment sequence .WSJ+1Reuters+1
💉 How Abecma Works
- T-cell Collection: T-cells are harvested from the patient’s blood.
- Genetic Modification: The collected T-cells are genetically engineered to express a BCMA-targeting CAR.
- Expansion: The modified T-cells are multiplied to sufficient numbers.
- Infusion: The expanded CAR T-cells are infused back into the patient to target and eliminate myeloma cells.U.S. Food and Drug Administration
This personalized approach ensures the therapy is tailored to each patient’s unique immune system.WSJ+6International Myeloma Foundation+6Drugs.com+6
📊 Efficacy
In clinical studies, Abecma demonstrated:abecma.com+1Reuters+1
- Overall Response Rate (ORR): 72%
- Complete Response (CR) Rate: 28%
- Duration of Response: Approximately 13.8 months for those achieving CR, compared to 4.4 months with standard treatments .abecma.com+1Reuters+1
⚠️ Safety and Side Effects
Common Adverse Reactions
- Cytokine Release Syndrome (CRS)
- Neurologic Toxicities
- Infections
- Fatigue
- Musculoskeletal Pain
- HypogammaglobulinemiaChemical & Engineering News+2abecma.com+2U.S. Food and Drug Administration+2abecma.com+4U.S. Food and Drug Administration+4Reuters+4
Serious Risks
- Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome
- Prolonged CytopeniasU.S. Food and Drug Administration+1Reuters+1
Patients are monitored for at least 7 days post-infusion at certified treatment centers to manage these risks .abecma.com
📦 Storage and Administration
- Storage: Abecma must be stored frozen in the vapor phase of liquid nitrogen (≤ -130°C).
- Thawing: Thawing is required prior to infusion, following specific guidelines.
- Administration: Infused intravenously at a certified treatment facility.Drugs.com
🏥 REMS Certification
Due to potential severe side effects, Abecma is available only through a Risk Evaluation and Mitigation Strategy (REMS) program. Healthcare facilities must be certified to administer this therapy and monitor for adverse reactions .U.S. Food and Drug Administration+3Drugs.com+3U.S. Food and Drug Administration+3
📍 Availability in India
As of now, Abecma is not approved for use in India. Patients interested in this therapy may consider clinical trial participation or explore alternative CAR T-cell therapies that are available domestically.