Lymphoma

Before initiating treatment, confirm the patient’s eligibility for this drug, as it is not indicated for the treatment of primary central nervous system lymphoma.

The therapeutic journey of Axicabtagene Ciloleucel begins with the collection of a patient’s T-cells through a process called leukapheresis.

In the case of axicabtagene ciloleucel, the T-cells are engineered to target and eliminate cells that express a protein called CD19, which is found on the surface of B-cells, including the cancerous B-cells in follicular lymphoma.

On December 21, 2023, Kite, a Gilead company, announced that the U.S. Food and Drug Administration (FDA) has approved a label update for Yescarta® (axicabtagene ciloleucel), incorporating the pivotal Phase 3 ZUMA-7 study’s overall survival (OS) analysis.

On March 5, 2021, the U.S. Food and Drug Administration (FDA) approved Axicabtagene ciloleucel (Yescarta, Kite Pharma, Inc.) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

On September 28, 2022, the European Commission (EC) approved the CD19 CAR-T cell therapy Yescarta (axicabtagene ciloleucel) for a new indication: the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) after one line of systemic therapy.

On June 28, 2022, local time, Gilead’s cell therapy company Kite Pharma announced that the European Commission (EC) has approved its CAR-T cell therapy Yescarta® (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy.

Axicabtagene ciloleucel (axi-cel) is an autologous CD19-directed chimeric antigen receptor (CAR) T-cell therapy that received FDA approval in 2017 for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and transformed follicular lymphoma (TFL).

Axicabtagene Ciloleucel is a type of chimeric antigen receptor (CAR) T-cell therapy, a cutting-edge form of immunotherapy.

In early April 2024, the U.S. Food and Drug Administration (FDA) approved an updated prescribing information for Yescarta (Axicabtagene Ciloleucel) to include overall survival (OS) data in adult patients with relapsed or refractory large B-cell lymphoma (LBCL) after first-line therapy containing Rituximab Injection and Anthracyclines.

On October 17, 2022, exciting news arrived from the European Commission (EC). Based on data from the ZUMA-7 study, the EC officially approved a new indication for Yescarta® for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) who are refractory to or relapse within 12 months after first-line chemoimmunotherapy.

On April 1, 2022, Kite, a U.S. company, announced that the U.S. Food and Drug Administration (FDA) has approved its CAR-T cell therapy drug Yescarta (Axicabtagene Ciloleucel) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL) after one prior line of systemic therapy, including patients who have progressed within 12 months of first-line chemoimmunotherapy.