China-based Fosun Kite Biotechnology Co., Ltd, a joint venture between Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196; HKG: 2196) and Gilead (NASDAQ: GILD) subsidiary Kite Pharma, has announced that its product Yescarta (axicabtagene ciloleucel) has obtained marketing approval from the National Medical Products Administration (NMPA) for a new indication in treating large B-cell lymphoma (r/r LBCL) that is refractory to first-line immunochemotherapy or has relapsed within 12 months of such treatment.
Yescarta’s Regulatory History and Indications
Yescarta was initially approved in the US and Europe for the treatment of lymphoma in October 2017 and August 2018, respectively. In June 2021, it received conditional approval in China to treat relapsed or refractory large B-cell lymphoma in adults after second-line or more systemic treatment. This includes various subtypes such as unspecified diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma, high-grade B-cell lymphoma, and transformed follicular lymphoma.
Significance of the New Indication
The recent approval expands Yescarta’s use in the Chinese market, providing a critical treatment option for patients with advanced large B-cell lymphoma who have limited alternatives following first-line therapy. This development highlights Fosun Kite’s commitment to addressing the needs of patients with aggressive forms of lymphoma and reinforces its position in the CAR T-cell therapy landscape.
