Yescarta (axicabtagene ciloleucel), from the Gilead Sciences subsidiary Kite, has become the first CAR-T therapy to win approval from the China National Medical Products Administration (NMPA).
Fosun Kite Biotechnology, a joint venture between Kite and Shanghai Fosun Pharmaceutical, has received approval to market the therapy for the treatment of relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma.
Terence O’Sullivan, vice president for the international region at Kite, said: “In relapsed or refractory LBCL, current standard-of-care is associated with poor long-term outcomes, so we are pleased to offer this new hope of survival for patients in China who are in need of new therapeutic options.”
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