Source: Pharmaceutical Technology
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. 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.
Source: Pharmaceutical Technology
MASH revival with over $2.5bn for innovator drug partnership deals in 2024
Source: Pharmaceutical Technology
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.”