What is ABECMA or idecabtagene vicleucel?
ABECMA is the trade name of idecabtagene vicleucel, manufactured by Celgene Corporation, a Bristol-Myers Squibb Company. ABECMA is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody – As per the US FDA. This happens to be the first cell-based gene therapy approved for adult patients with multiple myeloma. To be precise, ABECMA is a (CAR) T-cell therapy. The entire therapy is centered on the genetic modification of T-cells with a new gene which facilitates targeted killing of myeloma cells.
ABECMA – FDA Approved Cellular and Gene Therapy Product
ABECMA secured its US FDA approval in March 2021. This approval was based on a multicenter study of 127 patients. These are patients with relapsed or refractory multiple myeloma, they also received at least three prior therapies. The study outcomes were
convincing with 72% of patients responding to the treatment. 28% of patients in the study demonstrated complete response to the treatment. The 12 months assessment also indicated 65% of patients remained in complete response during the evaluation period.
ABECMA was granted Orphan Drug and Breakthrough Therapy designations by the FDA.More information can be found in the US FDA Press Release
How does treatment with ABECMA (idecabtagene vicleucel) work?
Cellular and Gene Therapies are way more advanced than treatments with Chemotherapy and Immunotherapy. Not all are drugs or products that can be administered under routine Hospital settings. ABECMA is a personalized solution which is developed by genetically modifying the patient’s own while blood cells. “Leukapheresis” is the process used to collect the WBC. These blood cells will be sent to the manufacturing facility where ABECMA is developed. Once the genetically modified solution is ready, ABECMA will be transported to the Healthcare facility. It would take 30 minutes for the infusion. A single dose of ABECMA contains a cell suspension of 300 to 460 x 106 CAR-positive T cells in one or more infusion bags. ABECMA is stored in the vapor phase of liquid nitrogen and supplied in a liquid nitrogen dry vapor shipper. Refer to the ABECMA Prescribing Information for more specific details.
Patients and caregivers can visit www.abecma.com for comprehensive information. The website provides avenues to find a treatment center and option to register. This is available for US patients at present.
ABECMA in India – Is there a possibility?
Right now there is limited information about ABECMA India. The active presence of BMS in India would certainly provide reasons for Indian patients to be hopeful about the future prospects. More information is likely to emerge in the days to come. You can write to us at nhs@noelgenomics.com to express your interest. We are committed to provide authentic information and assist Indian patients with access to advanced therapeutic solutions.
