Kite Pharma, a subsidiary of Gilead Sciences, and Daiichi Sankyo have received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for their Yescarta (axicabtagene ciloleucel) for initial treatment of relapsed/refractory large B-cell lymphoma (LBCL).

Yescarta, a chimeric antigen receptor (CAR) T-cell therapy, is used only in patients who have not received a prior transfusion of CAR T-cells targeted at CD19 antigen.

The approval was backed by the findings of ZUMA-7 clinical trial where patients with LBCL treated with Yescarta in second-line achieved four-fold greater improvement in event-free survival of 8.3 months vs. two months for standard of care (SOC).

Patients treated with Yescarta in ZUMA-7 clinical trial were 2.5 times more likely than SOC to be alive at two years without disease progression or need for additional treatments.

Christi Shaw — Kite Pharma CEO said: “We are very proud of this additional Yescarta approval in Japan.

“As Japan has the second-largest number of people diagnosed with non-Hodgkin lymphoma globally, this approval marks an important step in bringing this innovative therapy earlier to more patients.”

The Kite Cell Therapy Business Unit at Gilead Sciences K.K., the Japan subsidiary of Gilead Sciences, will sell and promote Yescarta in Japan after the marketing authorization transfer in 2023.

Wataru Takasaki — Daiichi Sankyo Japan R&D Division Head and Executive Officer said: “We are glad to have achieved this important milestone in order to provide an innovative treatment option to more patients with large B-cell lymphoma in Japan.”

The Japanese regulatory authorities have authorized Kite Pharma’s US production plant in El Segundo to begin production of Yescarta for the Japanese market in 2023.

The US FDA cleared Yescarta for this indication in April 2022 while the European Commission approved it in October 2022.

  axicabtagene ciloleucel, Christi Shaw, Daiichi Sankyo, El Segundo, Gilead Sciences, Japan, Kite Pharma, Lymphoma, Yescarta