NEW YORK – China's National Medical Products Administration (NMPA) on Tuesday approved Fosun Kite Biotechnology's autologous CAR T-cell therapy Yikaida (axicabtagene ciloleucel) as a second-line treatment for large B-cell lymphoma patients.
Yikaida, which is known as Yescarta in other markets, is sold in China by Fosun Kite Biotechnology, a joint venture between Gilead Sciences' Kite Pharma and Shanghai Fosun Pharmaceutical. Regulators in China approved Yikaida as third- or later-line treatment for LBCL patients in 2021.
The latest approval for the CD19-directed CAR T-cell therapy is for treating patients who do not respond or have relapsed within a year of receiving first-line treatment. The regulators based the approval on the results of the Phase III ZUMA-7 trial in which LBCL patients benefited from second-line CAR T-cell therapy versus standard-of-care treatment with a chemotherapy and stem cell transplant regimen.
In an updated analysis of ZUMA-7 presented during the American Society of Clinical Oncology's annual meeting this year, the CAR T-cell therapy was shown to reduce patients' risk of death by 27 percent versus standard-of-care treatment.
The US Food and Drug Administration in April 2022 approved second-line treatment with Yescarta for LBCL patients based on data from ZUMA-7. In October 2022, the European Commission did the same.
Bristol Myers Squibb's competing autologous CD19-directed CAR T-cell therapy Breyanzi (lisocabtagene maraleucel) is also approved for second-line LBCL in the US and in Europe. In China, however, the latest Yikaida approval marks the first CAR T-cell therapy approval in the earlier, second-line LBCL setting.