What is TECARTUS or brexucabtagene autoleucel?
TECARTUS is the trade name of brexucabtagene autoleucel, manufactured by Kite Pharma, a Gilead Sciences Company. TECARTUS is indicated for treatment of adult patients diagnosed with mantle cell lymphoma (MCL) who have not responded to or who have relapsed following other kinds of treatment – As per the US FDA. This is also the first cell-based gene therapy approved for mantle cell lymphoma (MCL). More precisely, TECARTUS is a (CAR) T-cell therapy. The complete therapy is based on a mechanism of targeting cancerous cells with genetically modified T-cells, by using patient’s own immune system.
TECARTUS – FDA Approved Cellular and Gene Therapy Product
TECARTUS received its US FDA approval in July 2020. This approval was based on a multicenter study of 60 adult patients. These are patients with refractory or relapsed MCL, who also received prior therapy. The key study outcomes highlight 87% of patients demonstrating objective response. Patients with objective response were also followed for at least six months. 62% complete remission rate is another important study outcome. 25% of patients have achieved partial remission. TECARTUS 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 TECARTUS (brexucabtagene autoleucel) work?
Cellular and Gene Therapies are highly sophisticated and advanced compared to treatments with Chemotherapy and Immunotherapy. Unlike drugs or other medical products that are administered under routine Hospital settings, they require personalized approach.TECARTUS is a patient specific solution that is developed through genetic modification process. This requires patient’s own while blood cells. A procedure called “Leukapheresis” is used to collect the WBC. These extracted blood cells are used to develop TECARTUS at the company’s manufacturing facility. After the genetically modified product is prepared, TECARTUS will be sent to the authorized Healthcare facility. It is administered through single intravenous infusion that takes around 30 minutes. TECARTUS comprises a suspension of 2 × 106 CAR-positive viable T cells per kg of body weight, with a maximum of 2 × 108 CAR-positive viable T cells in approximately 68 mL. TECARTUS is stored in the vapor phase of liquid nitrogen and supplied in a liquid nitrogen dry shipper. Refer to the TECARTUS Prescribing Information for specific information.
Patients and caregivers can visit www.tecartus.com for comprehensive information. The website provides guidance to find a treatment center and patient support information. Patients from the US and Europe are likely to access it at present.
TECARTUS in India – Is there a possibility?
Information regarding TECARTUS India is limited for now. It may take time for more authorized centers to be registered and get necessary approvals. You can write to us at nhs@noelgenomics.com and share your interest. We remain committed to share authentic information and support Indian patients with access to advanced therapeutic solutions.
