[ad_1]
– Axicabtagene Cilouleucel (FKC876) is approved for adult patients with relapsed or refractory large B-cell lymphoma–
– Positive results of Chinese patient multicenter trials support approval –
Kite, a subsidiary of Gilead, announced that Fosun Kite Biotechnology Co., Ltd., a joint venture between Kite and Shanghai Fosun Pharmaceutical (Group) Co., Ltd., has obtained axicabtagene ciloleucel approved by the National Medical Products Administration (NMPA) for treatment of two or more Adult patients with relapsed or refractory large B-cell lymphoma (LBCL) after systemic treatment, including unspecified diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL)), High-grade B-cell lymphoma and DLBCL caused by follicular lymphoma.
Axicabtagene ciloleucel is the first and only commercial chimeric antigen receptor (CAR) T cell therapy in China.
“In relapsed or refractory LBCL, the current standard treatment is associated with poor long-term outcomes, so we are happy to provide this new hope of survival for Chinese patients who need new treatment options,” said Terence O’Sullivan, Kite International Regional Vice President. “Thanks to the dedicated healthcare professionals, patients and caregivers who have worked with the Fosun Kite team to make this treatment program available in China.”
Axicabtagene Cilouleucel, FKC876, is an autologous CD19-directed CAR T cell therapy, manufactured in China and licensed by Kite’s YESCARTA® (Axicabtagene Cilouleucel).
The approval is based on the results of a single-arm, open-label, multi-center bridging trial (FKC876-2018-001), which evaluated the effectiveness and safety of FKC876 in the treatment of Chinese patients with refractory intermediate invasive non-Hodgkin’s lymphoma Sexual (NHL)/Large B-cell lymphoma in China.
About YESCARTA® (Axicabtagene Cilouleucel)
YESCARTA® is the world’s first approved CAR T cell therapy for the treatment of adult patients with certain types of non-Hodgkin’s lymphoma (NHL). On October 18, 2017, the U.S. Food and Drug Administration (FDA) approved it to be marketed in the United States for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after receiving two or more lines of systemic therapy, including diffuse Large B-cell lymphoma. -Cell Lymphoma (DLBCL) Not otherwise specified, DLBCL caused by primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and follicular lymphoma. On August 27, 2018, YESCARTA ® was also approved by the European Medicines Agency (EMA) Committee for the EU market for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal enlargement Adult patients with B-cell lymphoma. PMBCL), after two or more lines of systemic therapy.
About Kite
Kite, a company under Gilead, is a global biopharmaceutical company headquartered in Santa Monica, California, with commercial manufacturing operations in North America and Europe. Kite’s sole focus is on cell therapy for the treatment and potential cure of cancer. As a leader in cell therapy, Kite has more approved CAR T indications than any other company and can help more patients.For more information about kites, please visit www.kitepharma.com.
About Fosun Kite
As a joint venture between Shanghai Fosun Pharmaceutical (Group) Co., Ltd. and Kite Pharma, Inc., Fosun Kite is committed to promoting and commercializing innovative cell therapies in China for the benefit of patients. Fosun Kite’s headquarters is located in Shanghai’s Zhangjiang Hi-Tech Park and has commercial manufacturing facilities (approximately 10,000 m2) In Zhangjiang Innovative Medicine Industrial Park, 2000 meters have been built2 The R&D center has a professional and experienced R&D team that uses a combination of internal R&D and external cooperation to build a sustainable pipeline that includes CAR-T/TCR-T projects in the discovery and clinical stages.For more information, please visit www.fosunkitebio.com.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that has been pursuing and making breakthroughs in the medical field for 30 years, with the goal of creating a healthier world for all. The company is committed to advancing the research and development of innovative drugs to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries around the world and is headquartered in Foster City, California.
Forward-looking statements
This press release contains…
The full story on Benzinga.com
[ad_2]
Source link
