Axicabtagene ciloleucel

Axicabtagene ciloleucel is an anti-CD19 chimeric antigen receptor (CAR) T-cell therapy. The drug has a unique mechanism of action, as it utilizes the patient's own T cells, which play a central role in immune response to cancer. Once T-cells are collected from the patient, they are genetically engineered to express anti-CD19 CARs that recognize and kill cancer cells, and are infused back into the patient. Each dose of axicabtagene ciloleucel represent the patient's genetically modified T-cells. The development of resulted from early preclinical studies conducted by a group of researchers at the National Cancer Institute (NCI), who demonstrated that T cells expressing an anti-CD19 CAR can produce cytokines that efficiently kill leukemic cells in vitro. Axicabtagene ciloleucel was approved by the FDA on October 18th, 2017. It is marketed under the brand name Yescarta and is used to treat large B-cell lymphomas and follicular lymphoma in adults. Axicabtagene ciloleucel was later approved by the EMA on August 23, 2018.

Axicabtagene ciloleucel is an anti-CD19 chimeric antigen receptor (CAR) T-cell therapy. The drug has a unique mechanism of action, as it utilizes the patient's own T cells, which play a central role in immune response to cancer. Once T-cells are collected from the patient, they are genetically engineered to express anti-CD19 CARs that recognize and kill cancer cells, and are infused back into the patient. Each dose of axicabtagene ciloleucel represent the patient's genetically modified T-cells. The development of resulted from early preclinical studies conducted by a group of researchers at the National Cancer Institute (NCI), who demonstrated that T cells expressing an anti-CD19 CAR can produce cytokines that efficiently kill leukemic cells in vitro. Axicabtagene ciloleucel was approved by the FDA on October 18th, 2017. It is marketed under the brand name Yescarta and is used to treat large B-cell lymphomas and follicular lymphoma in adults. Axicabtagene ciloleucel was later approved by the EMA on August 23, 2018.

In the US, axicabtagene ciloleucel is indicated for the treatment of adults with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. In the US and Europe, it is used to treat adults 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. Axicabtagene ciloleucel is also used to treat adults with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy in the US, or three or more lines of systemic therapy in Europe.

• Refractory Diffuse Large B Cell Lymphoma (DLBCL)
• Refractory Follicular Lymphoma
• Refractory Large B-cell Lymphoma
• Refractory Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma
• Relapsed Diffuse Large B-cell Lymphoma (DLBCL)
• Relapsed Follicular Lymphoma
• Refractory High Grade B-cell Lymphoma (HGBCL)
• Relapsed High Grade B-cell Lymphoma (HGBCL)
• Relapsed Primary Mediastinal Large B-Cell Lymphoma (PMBCL)