What is BREYANZI or lisocabtagene maraleucel?
BREYANZI is the commercial brand name for lisocabtagene maraleucel. It is developed by Juno Therapeutics, a company of Bristol-Myers Squibb. BREYANZI is indicated for the treatment of adult patients with relapsed or refractory relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B – As per the US FDA. This happens to be the first cell-based CAR-T treatment by BMS to be approved. BREYANZI gets its approval under the category of Cellular and Gene Therapy Products as categorized by the FDA. The entire therapy is centered on the mechanism of reprogramming patient’s T-cells, which can identify and target lymphoma cells.
BREYANZI – FDA Approved Cellular and Gene Therapy Product
BREYANZI received its US FDA approval in February 2021. This approval was based on the evaluation of 192 patients. They participated in a single-arm, open label, multicenter trial TRANSCEND. The trial outcomes indicate 73% overall response rate with 54% of patients achieving complete response. Among the patients who experienced complete response, 65% remained in remission for six months. The percentage of patients whose remission lasted for nine months was 62%. BREYANZI was granted Orphan Drug and Breakthrough
Therapy designations apart from Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA. More information can be found in the US FDA Press Release.
How does treatment with BREYANZI (lisocabtagene maraleucel) work?
The way Cellular and Gene Therapies work is a lot more different, rather advanced in comparison with chemotherapy or even immunotherapy. Unlike drugs or finished medical products that are administered in Hospital settings, some of them require personalization. BREYANZI is a customized based on genetically reprogrammed patient cells. Through a process called “Leukapheresis”, patient’s own White Blood Cells are collected for the same purpose. The T-cells are extracted through a process called Apheresis. BREYANZI is ultimately developed at the CAR T cell manufacturing, based on the patient’s T-cells. Upon the completion of reprogramming process, BREYANZI will be sent to the treating facility. It is administered through an infusion procedure that takes about fifteen minutes. A single dose of BREYANZI contains 50 to 110 × 106 CAR positive viable T cells, with each component supplied separately in one to four single-dose 5 mL vials. Each mL contains 1.5 × 106 to 70 × 106 CAR-positive viable T cells. Refer to the BREYANZI Prescribing Information for more specific details.
Patients and caregivers can visit www.breyanzi.com for more information and updates. The website has options to find a treatment center and check for eligibility. This is most likely applicable for the patients in US.
BREYANZI in India – Is it possible?
Right now there is no clear information about BREYANZI India. BMS has its offices and executive presence in India. This can help in facilitating advanced treatments with better coordination. More information may be available in the near future. You may email us
(nhs@noelgenomics.com) and express interest to receive new updates. We are committed to share authentic access information. It is our endeavor to assist Indian patients seeking advanced therapies.
