Axicabtagene Ciloleucel of Fosun Kite Included in the Breakthrough Therapeutic Drug Program
(Shanghai, China)
Fosun Kite Biotechnology Co., Ltd. announced today that the National Medical Products Administration (NMPA) has officially included the new indication of Axicabtagene Ciloleucel, a CD19-targeted autologous CAR-T cell therapy product of Fosun Kite, into the Breakthrough Therapy Designation (BTD) for the treatment of relapsed or refractory indolent non-Hodgkin's lymphoma (r/r iNHL), including follicular lymphoma (FL) and marginal zone lymphoma (MZL), after two or more lines of systemic therapy.
Mr. Huang Hai, CEO of Fosun Kite, said: "The inclusion of Axicabtagene Ciloleucel in the BTD demonstrates the support of NMPA for clinical value-oriented drug innovation and also shows the clinical advantages and potential of this drug in the treatment of r/r iNHL. Fosun Kite will accelerate the clinical phase of the new indication of the drug and proactively communicate with the Center for Drug Evaluation (CDE) to bring new hope and opportunities for more patients with NHL in China as soon as possible. "
About iNHL
Indolent non-Hodgkin lymphoma (iNHL) is a malignancy that progresses slowly but becomes more aggressive over time. Follicular lymphoma (FL) and marginal zone lymphoma (MZL) are both common subtypes. FL is also the second most common type of lymphoma worldwide, accounting for approximately 22% of confirmed cases of NHL worldwide. MZL is the third most common lymphoma, accounting for approximately 8% to 12% of all B-cell NHL 1. Although the long-term survival of FL patients has been considerably improved with advances in disease management, there are great differences in prognosis. At present, there is no standard treatment for r/r FL patients after two or more lines of therapy, and treatment options for r/r MZL patients are also very limited.
About Axicabtagene Ciloleucel
Axicabtagene Ciloleucel is an autologous CD19-directed CAR-T cell therapy manufactured in China and introduced by Fosun Kite pursuant to a license from Kite, a Gilead Company ("Kite") of Kite's Yescarta (axicabtagene ciloleucel) in early 2017. Its NDA for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (including diffuse large B-cell lymphoma - not otherwise specified (DLBCL-NOS), primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL transformed from follicular lymphoma) after two or more lines of prior systemic therapy has been approved by the NMPA for marketing in June 2021.
About Yescarta
Yescarta has been approved by the US FDA on October 18, 2017 for the treatment of adult patients with r/r LBCL, including DLBCL-NOS, primary mediastinal B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and DLBCL transformed from follicular lymphoma, and is the first CAR-T cell drug approved by the US FDA for specific non-Hodgkin lymphoma.
On March 5, 2021, its application for an expanded indication for the treatment of adult patients with r/r FL was granted accelerated approval by the US FDA and became the world's first CAR-T cell therapy product approved for marketing for FL. Based on the results of the ZUMA-5 single-arm, open-label, multicenter trial, 104 patients with iNHL who were evaluable for efficacy achieved an overall response rate (ORR) of 92% and a complete response rate (CR) of 76% at a median follow-up of 17.5 months, including 94% ORR and 80% CR in FL patients, median DOR, PFS, and OS had not yet been reached, 64% of FL patients remained in response at the data cutoff, and no new Axi-Cel related AEs were identified in ZUMA-5 2.
About Fosun Kite
As a joint venture between Shanghai Fosun Pharmaceutical (Group) Co., Ltd. and Kite Pharma, Inc., Fosun Kite Biotechnology Co., Ltd. (hereinafter referred to as "Fosun Kite") is dedicated to the advancement and commercialization of innovative cell therapies in China to benefit patients. Headquartered in Zhangjiang Hi-tech Park of Shanghai, Fosun Kite has a 10,000 m2 CAR-T commercial manufacturing facility which has been completed and put into use in Zhangjiang Biotech and Pharmaceutical Industrial Base. Moreover, Fosun Kite has also built a 2,000 m2 R&D center with a professionally experienced R&D team, taking a combined approach of internal R&D effort and external partnering to build a sustainable pipeline including CAR-T programs in both early discovery and clinical stages.
For more information about Fosun Kite, please visitwww.fosunkitebio.com
Data source:
1. NCCN Guideline V1. 2020 B-cell Lymphomas
2. Jacobson CA, et al. 2020 ASH Oral Abstract 700.
Fosun Kite Biotechnology Co., Ltd. announced today that the National Medical Products Administration (NMPA) has officially included the new indication of Axicabtagene Ciloleucel, a CD19-targeted autologous CAR-T cell therapy product of Fosun Kite, into the Breakthrough Therapy Designation (BTD) for the treatment of relapsed or refractory indolent non-Hodgkin's lymphoma (r/r iNHL), including follicular lymphoma (FL) and marginal zone lymphoma (MZL), after two or more lines of systemic therapy.
Mr. Huang Hai, CEO of Fosun Kite, said: "The inclusion of Axicabtagene Ciloleucel in the BTD demonstrates the support of NMPA for clinical value-oriented drug innovation and also shows the clinical advantages and potential of this drug in the treatment of r/r iNHL. Fosun Kite will accelerate the clinical phase of the new indication of the drug and proactively communicate with the Center for Drug Evaluation (CDE) to bring new hope and opportunities for more patients with NHL in China as soon as possible. "
About iNHL
Indolent non-Hodgkin lymphoma (iNHL) is a malignancy that progresses slowly but becomes more aggressive over time. Follicular lymphoma (FL) and marginal zone lymphoma (MZL) are both common subtypes. FL is also the second most common type of lymphoma worldwide, accounting for approximately 22% of confirmed cases of NHL worldwide. MZL is the third most common lymphoma, accounting for approximately 8% to 12% of all B-cell NHL 1. Although the long-term survival of FL patients has been considerably improved with advances in disease management, there are great differences in prognosis. At present, there is no standard treatment for r/r FL patients after two or more lines of therapy, and treatment options for r/r MZL patients are also very limited.
About Axicabtagene Ciloleucel
Axicabtagene Ciloleucel is an autologous CD19-directed CAR-T cell therapy manufactured in China and introduced by Fosun Kite pursuant to a license from Kite, a Gilead Company ("Kite") of Kite's Yescarta (axicabtagene ciloleucel) in early 2017. Its NDA for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (including diffuse large B-cell lymphoma - not otherwise specified (DLBCL-NOS), primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL transformed from follicular lymphoma) after two or more lines of prior systemic therapy has been approved by the NMPA for marketing in June 2021.
About Yescarta
Yescarta has been approved by the US FDA on October 18, 2017 for the treatment of adult patients with r/r LBCL, including DLBCL-NOS, primary mediastinal B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and DLBCL transformed from follicular lymphoma, and is the first CAR-T cell drug approved by the US FDA for specific non-Hodgkin lymphoma.
On March 5, 2021, its application for an expanded indication for the treatment of adult patients with r/r FL was granted accelerated approval by the US FDA and became the world's first CAR-T cell therapy product approved for marketing for FL. Based on the results of the ZUMA-5 single-arm, open-label, multicenter trial, 104 patients with iNHL who were evaluable for efficacy achieved an overall response rate (ORR) of 92% and a complete response rate (CR) of 76% at a median follow-up of 17.5 months, including 94% ORR and 80% CR in FL patients, median DOR, PFS, and OS had not yet been reached, 64% of FL patients remained in response at the data cutoff, and no new Axi-Cel related AEs were identified in ZUMA-5 2.
About Fosun Kite
As a joint venture between Shanghai Fosun Pharmaceutical (Group) Co., Ltd. and Kite Pharma, Inc., Fosun Kite Biotechnology Co., Ltd. (hereinafter referred to as "Fosun Kite") is dedicated to the advancement and commercialization of innovative cell therapies in China to benefit patients. Headquartered in Zhangjiang Hi-tech Park of Shanghai, Fosun Kite has a 10,000 m2 CAR-T commercial manufacturing facility which has been completed and put into use in Zhangjiang Biotech and Pharmaceutical Industrial Base. Moreover, Fosun Kite has also built a 2,000 m2 R&D center with a professionally experienced R&D team, taking a combined approach of internal R&D effort and external partnering to build a sustainable pipeline including CAR-T programs in both early discovery and clinical stages.
For more information about Fosun Kite, please visitwww.fosunkitebio.com
Data source:
1. NCCN Guideline V1. 2020 B-cell Lymphomas
2. Jacobson CA, et al. 2020 ASH Oral Abstract 700.