Axicabtagene Ciloleucel (Yescarta) Approved: Bringing New Hope to Patients with Relapsed or Refractory Lymphoma
Axicabtagene Ciloleucel (Yescarta) Approved: Bringing New Hope to Patients with Relapsed or Refractory Lymphoma
I. Introduction
Yescarta (Axicabtagene Ciloleucel, Chinese name: 阿基仑赛, Chinese trade name: 奕凯达) is a revolutionary CAR-T cell therapy that represents a major breakthrough in cancer treatment. This therapy modifies the patient’s T cells to enable them to recognize and attack CD19-positive cancer cells, thereby providing new hope for patients with certain types of cancer. The following is a comprehensive introduction to the approval overview of Yescarta.
II. Yescarta’s Approval History
The approval history of Yescarta is a medical innovation story that spans across borders.
In October 2017, it was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.
On April 1, 2022, the FDA further approved Yescarta for the second-line treatment of adult patients with large B-cell lymphoma (LBCL).
On August 31, 2018, Kite, a Gilead company, announced that the European Commission (EC) has granted marketing authorization for Yescarta® (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy. The marketing authorization approval covers axicabtagene ciloleucel in the European Union member states, Norway, Iceland, and Liechtenstein.
On June 29, 2022, the European Commission (EC) announced the approval of Yescarta for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after three or more lines of systemic therapy. This is the second indication for Yescarta in the European Union and the third cell therapy indication approved for Kite in the EU.
On June 22, 2021, the National Medical Products Administration (NMPA) of China officially approved the new drug application for axicabtagene ciloleucel (Chinese trade name: Yikeda®) from Fosun Kite, making it the first approved CAR-T cell therapy product in China, primarily for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.
In June 2023, the new indication for axicabtagene ciloleucel (adult large B-cell lymphoma that is refractory to or relapses within 12 months after first-line immunochemotherapy) was officially approved for marketing by the NMPA. Previously, there were no CAR-T cell therapy products approved in China for the treatment of adult large B-cell lymphoma that is refractory to or relapses within 12 months after first-line immunochemotherapy. The approval of this new second-line indication represents a significant advancement in the treatment of adult large B-cell lymphoma and brings more hope to patients who are refractory to or relapse after first-line immunochemotherapy.
III. Efficacy and Safety of Yescarta
The efficacy and safety of Yescarta are key factors in its widespread recognition. In the pivotal ZUMA-5 clinical trial, Yescarta demonstrated outstanding efficacy in treating R/R FL patients. Data showed that in patients who had received three or more prior lines of systemic therapy, the overall response rate (ORR) was as high as 91%, and the complete response rate (CR) was 77%. The median duration of response (DoR) was 38.6 months, with 56% of patients remaining in response at 24 months.
In terms of safety, Yescarta’s performance was equally impressive. Although adverse events such as cytokine release syndrome (CRS) and neurological events may occur during treatment, most CRS cases were resolved by the data cutoff, and neurological events were also resolved within a short period. Overall, Yescarta demonstrated a manageable safety profile with a relatively low incidence of serious adverse events.
IV. Clinical Application Prospects of Yescarta
The promising clinical application prospects of Yescarta lie in its unique efficacy and mechanism. As an immunotherapy based on the patient’s own T cells, Yescarta can precisely recognize and attack tumor cells expressing specific antigens, enabling personalized treatment. This treatment approach not only offers high efficacy but also reduces reliance on traditional chemotherapeutic drugs and lowers the incidence of side effects.
As Yescarta’s indications continue to expand and its clinical application deepens, its position in cancer treatment will become more solid. In the future, Yescarta is expected to play a role in the treatment of more types of cancer, bringing good news to more patients.
V. Conclusion
As a leader in the CAR-T field, Yescarta has gained widespread recognition worldwide for its outstanding efficacy and safety. With the continuous deepening of clinical application and the expansion of indications, Yescarta will play an increasingly important role in cancer treatment. We look forward to Yescarta continuing to bring good news to more patients and contributing to the advancement of cancer treatment to new heights.