China accepts Innovent-HUTCHMED’s endometrial cancer therapy NDA
2024-04-03
临床2期优先审批申请上市上市批准突破性疗法
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来源: Pharmaceutical Technology
The companies sought approval for sintilimab and fruquintinib to treat advanced endometrial cancer. Credit: Fancy Studio / Shutterstock.com.
The China National Medical Products Administration (NMPA) has granted priority review for Innovent Biologics and Hutchmed’s new drug application (NDA) for the combination of sintilimab and fruquintinib for advanced endometrial cancer.
The NDA seeks a new therapeutic regimen for people with proficient mismatch repair or non-microsatellite instability-high tumours who have exhausted previous systemic therapies and are not eligible for curative surgical procedures or radiation.
Sintilimab is a programmed cell death protein 1 immunoglobulin G4 monoclonal antibody, marketed in China as TYVYT (sintilimab injection). It has been developed through a collaboration between Innovent and Eli Lilly.
The application is based on the data from the FRUSICA-1 study, a Phase II multicentre, open-label trial.
The primary measure of success was the objective response rate as assessed by an independent review committee.
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Disease control rate, duration of response, progression-free survival, overall survival and pharmacokinetic assessments were the secondary endpoints.
In July 2023, the NMPA recognised the potential of the combination therapy, granting it a breakthrough designation. This status is reserved for treatments that offer a significant advancement over existing options for serious ailments lacking effective therapies, and where clinical evidence indicates substantial benefits.
Innovent senior vice-president Dr Hui Zhou stated: “TYVYT (sintilimab injection), as a backbone therapy in immuno-oncology, in combination with an anti-angiogenetic drug, may improve the prognosis for endometrial cancer patients in China.
“We are excited about the NDA acceptance and priority review designation, which increases our potential to bring a new treatment option to endometrial cancer patients, and concurrently strengthens the leadership position of TYVYTin China.”
In August 2023, the company received approval from China NMPA for SINTBILO (tafolecimab injection) for primary hypercholesterolemia and mixed dyslipidemia.
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