Yescarta FDA Approval for Second-Line Treatment of Large B-Cell Lymphoma on April 1, 2022
Yescarta FDA Approval for Second-Line Treatment of Large B-Cell Lymphoma on April 1, 2022
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.
Yescarta Became the First FDA-Approved CAR-T Drug for Second-Line Treatment of LBCL
This approval was based on the results of the ZUMA-7 clinical trial. Compared with the previous standard therapy, Yescarta prolonged the event-free survival by 6.3 months, and the two-year progression-free survival rate or survival rate without requiring additional cancer treatment was 2.5 times higher than the previous standard therapy. This approval also means that Yescarta has become the first FDA-approved CAR-T drug for second-line treatment of LBCL. As early as 2017, Yescarta was approved for the treatment of adult patients with relapsed or refractory LBCL after two or more lines of systemic therapy.
Commenting on this, Professor Ma Jun, Director of the Harbin Institute of Hematology and Oncology, Supervisor of the Chinese Society of Clinical Oncology (CSCO), and Vice Chairman of the Asian Clinical Oncology Society, said: “This is a major advancement in CAR-T cell therapy. The efficacy of Yescarta is significantly superior to the standard therapy for relapsed or refractory LBCL patients over the past 30 years, fundamentally changing the way people view the treatment of malignant hematological tumors. It has the potential to become the new standard of care and could drive a paradigm shift in the treatment of these patients.”
Dr. Huang Hai, CEO of FOSUN Kite, said: “The FDA approval of Yescarta for second-line treatment of LBCL is a milestone, bringing hope to more lymphoma patients. FOSUN Kite will promptly initiate the registration process for second-line treatment of LBCL in China, with the aim of bringing this innovative therapy to more Chinese patients as soon as possible.”
Yescarta Demonstrated Superior Efficacy Compared to Standard Therapy
In the United States, more than 18,000 new cases of LBCL are diagnosed each year, and due to cancer relapse or refractory disease (failure to achieve remission after initial treatment), 30%-40% of LBCL patients require second-line treatment. Data shows that in 2018, there were 88,090 new cases of non-Hodgkin’s lymphoma (NHL) in China, with LBCL being the most common type of NHL.
It is understood that the FDA based this approval on the results of the ZUMA-7 clinical trial, which is one of the largest global clinical trials comparing CAR-T therapy with the previous standard of care used for decades. It is a randomized, open-label, global, multicenter phase 3 study evaluating the safety and efficacy of Yescarta versus the previous standard second-line treatment in adult patients with relapsed or refractory LBCL within 12 months of first-line therapy. In this study, 359 patients from 77 global centers were randomized in a 1:1 ratio to receive either a single infusion of Yescarta or the previous standard second-line treatment. Yescarta treatment showed statistically significant clinical advantages, with a four-fold improvement in event-free survival (EFS) compared to the previous standard second-line treatment, prolonging it by 6.3 months (8.3 months vs. 2.0 months). Patients receiving Yescarta had a two-year progression-free survival rate or survival rate without requiring additional cancer treatment that was 2.5 times higher than the previous standard second-line treatment (40.5% vs. 16.3%), with manageable safety. These study data were presented at the 2021 American Society of Hematology (ASH) annual meeting in December and simultaneously published in the New England Journal of Medicine (NEJM).
The First CAR-T Cell Drug Recommended as Category 1 by NCCN
Due to Yescarta’s outstanding efficacy, in March 2022, the National Comprehensive Cancer Network (NCCN) in the United States included it as a Category 1 recommendation for the treatment of “relapsed disease within 12 months or primary refractory disease” in diffuse LBCL. It also became the first CAR-T cell drug recommended as Category 1 by NCCN for the treatment of any cancer type.
Industry analysts believe that this approval is a milestone in the development of CAR-T cell therapy, as it is the first time the FDA has approved a CAR-T drug to replace the long-standing standard of care, marking a significant treatment paradigm shift. Patients only need to receive a single infusion treatment instead of the previous multi-step treatment regimen, and compared to the previous standard therapy, CAR-T treatment significantly improves patients’ quality of life after treatment.
In the Chinese market, FOSUN Kite, a joint venture between Fosun Pharma and Kite in the United States, has obtained the technology license and commercialization rights for Yescarta. In June 2021, China’s National Medical Products Administration (NMPA) officially approved the marketing application for Yescarta, making it the first approved cell therapy product in China for the treatment of adult patients with relapsed or refractory LBCL after two or more lines of systemic therapy.
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