Axi-Cel Approved in Japan for the Treatment of Lymphoma Subtype

Japanese patients with relapsed/refractory large B-cell lymphoma can now receive treatment with axicabtagene ciloleucel following its approval.

Axicabtagene ciloleucel (Yescarta; axi-cel) was approved by the Japan Ministry of Health, Labour, and Welfare for the treatment of patients with relapsed/refractory large B-cell lymphoma, according to a press release from Kite Pharmaceuticals.1

The indication includes patients with advanced large B-cell lymphoma, diffuse large B-cell lymphoma (DLBCL)—the most common type of non-Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, transformed follicular lymphoma, and high-grade B-cell lymphoma.

The designation was supported by data from the phase 3 ZUMA-7 study (NCT03391466), which assessed axi-cel in patients with relapsed/refractory DLBCL. Treatment with axi-cel resulted in a median event-free survival of 8.3 months vs 2.0 months among those treated with standard of care (HR, 0.40; 95% CI, 0.31-0.51; P < .0001).

Additionally, 41% of patients in the axi-cel arm were alive and without disease progression at 2 years vs 16% in the standard of care arm.

“We are very proud of this additional Yescarta approval in Japan,” Christi Shaw, CEO of Kite, said in the press release. “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 FDA approved axi-cel for adults with relapsed/refractory LBCL in April 2022 based on the results from ZUMA-7.2

References

  1. Yescarta® now approved in Japan for initial treatment of relapsed/refractory large B-cell lymphoma. News release. Kite Pharma. December 22, 2022. Accessed January 5, 2023. https://bit.ly/3ZgNejF
  2. FDA approves axicabtagene ciloleucel for second-line treatment of large B-cell lymphoma. News release. FDA. April 1, 2022. Accessed April 1, 2022. https://bit.ly/3LAUUFD