What is YESCARTA or axicabtagene ciloleucel?
YESCARTA is the trade name for axicabtagene ciloleucel, manufactured by Kite Pharma, a Company of Gilead Sciences. YESCARTA is indicated for the treatment of adult patients with 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, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. – As per the US FDA. This happens to be the first cell-based gene therapy approved for Indolent Follicular Lymphoma. YESCARTA is more specifically a (CAR) T-cell therapy. The whole therapy can be described as a CD19-directed genetically modified autologous T cell immunotherapy.
YESCARTA – FDA Approved Cellular and Gene Therapy Product
YESCARTA secured its first US FDA approval in October 2017. This approval was for relapsed or refractory large B-cell lymphoma treatment. In March 2021, FDA grants accelerated approval for relapsed or refractory follicular lymphoma treatment. The FDA approval for large B-cell lymphoma was based on the assessment of 101 patients from a single-arm, open-label, multi-centre study. The key outcomes of this trial include an improved objective response rate in 72% of patients and 51% of patients experiencing complete remission. The follicular lymphoma approval by FDA was based on the primary efficacy analysis in 81 patients, also in a single-arm, open-label, multi-centre study. The overall response rate was 91% with 60% complete remission rate in this trial. YESCARTA was given the Orphan Drug and Breakthrough Designations. More information can be found in the US FDA Press Release.
How does treatment with YESCARTA (axicabtagene ciloleucel) work?
Cellular and Gene Therapies work differently. They have complete different mechanism when compared with Chemotherapy and Immunotherapy products. These are not medications that are infused through conventional procedures in the Hospital settings. YESCARTA is a personalized therapy that involves genetic modification of patient’s own while blood cells. WBCs are collected through a process known as “Leukapheresis”. These extracted cells are shipped to the manufacturing center for YESCARTA development. As and when the genetically modified therapy is available, YESCARTA will be sent back to the treatment facility. YESCARTA 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. It is stored in the vapor phase of liquid nitrogen and supplied in a liquidnitrogen dry shipper. Refer to the YESCARTA Prescribing Information for more specific details.
Patients and caregivers can visit www.yescarta.com for comprehensive information. The website provides official account of the innovator company. Patients can also reach out through KiteKonnect to find about the authorized treatment centers and additional resources.
YESCARTA in India – Is there a possibility?
We have very limited information regarding YESCARTA India. The presence of Gilead Sciences in the region can help in expanding avenues for treatment with new advancements. More information may be available in the near future. You can contact us at nhs@noelgenomics.com Our commitment is to help patients in India with access to advanced treatment options, as and when available.
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