The product of Fosun Kite Biotechnology jointly established by Shanghai Fosun Pharmaceutical and Kite Pharma of the United States (trade name: Yikaida®) for the treatment of adult large B-cell lymphoma (r/r LBCL) who failed first-line immunochemotherapy or relapsed within 12 months conditionally approved by the State Drug Administration ("NMPA"). This also marks the official launch of Yikaida® for second-line indication.
Previously, there was no CAR-T cell therapy product in China for the treatment of adult large B-cell lymphoma who failed to respond to first-line immunochemotherapy or relapsed within 12 months after first-line immunochemotherapy. Fosun Kite's Yikaida® added a second-line indication. The approval for marketing of the drug has successfully promoted new progress in the treatment of adult large B-cell lymphoma, bringing hope to more patients who have failed or relapsed with first-line immunochemotherapy. At the same time, Yikaida® is currently the first approved CAR-T cell therapy product in China for this new indication.
Professor Ma Jun from the Harbin Institute of Hematology and Oncology said, "The latest research shows that the incidence of lymphoma in China is increasing year by year. How to improve the prognosis of lymphoma treatment and improve the clinical cure rate has attracted the attention of the industry. If innovative therapy is limited to the later line, the curative effect will be discounted, and the patient's benefit will be limited."
One of the shareholders of Fosun Kite, Kite, the global cell therapy leader, its ZUMA-7 study is the first head-to-head challenge salvage chemotherapy + autologous transplantation for LBCL patients with primary refractory or recurrence within 12 months after first-line treatment in the past 30 years, A large international multicenter RCT study. Based on Kite's ZUMA-7 study, Axi-cel was approved by the FDA in April 2022 for the treatment of adults with LBCL who are refractory or have relapsed within 12 months of first-line treatment. The OS data of ZUMA-7 was announced at the American ASCO meeting in June this year. The median follow-up time was 47.2 months. The Axi-cel group did not reach the median OS, while the standard treatment (SOC) group was 31.1 months, and the HR value was 0.726, that is to say, the second-line use of Kite's Axi-cel CART product reduced the risk of death by 27%.
Huang Hai, CEO of Fosun Kite, said: "Yikaida® has treated more than 500 patients with relapsed/refractory large B-cell lymphoma since the second anniversary of its launch. With its excellent real-world curative effect, stable drug quality control, and continuous improvement. The availability of medicines has been highly recognized by the public. Here, we would like to express our gratitude and heartfelt thanks to the experts, scholars, and patient families and our Shareholders, Fosun Pharmaceutical (Group), and Kite Pharma, for their trust and support of Fosun Kate and Yikaida®.
The approval of the new second-line indications of Yikaida® is a key step taken by Fosun Kate and its shareholders to address China's major unmet medical needs of lymphoma patients, and it is also a key step for China's drug review and approval bureau. For the great efforts in the approval and supervision of innovative drugs, we would like to express our sincere gratitude to the government departments and regulatory agencies for their care and guidance at the glorious moment when new indications are approved!
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