China’s National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for enfortumab vedotin for urothelial cancer.
The approval is in patients with locally advanced or metastatic urothelial cancer (la/mUC) who have received prior treatment with a PD-1/L1 inhibitor and platinum-based chemotherapy.
“In China, there were nearly 86,000 new cases of bladder cancer in 2020, and we are working with the NMPA to seek approval for enfortumab vedotin for patients with advanced stage disease,” said Ahsan Arozullah, Senior Vice President and Head of Development Therapeutic Areas, Astellas.
“Enfortumab vedotin has become a second- and third-line treatment option for many patients around the world with previously treated locally advanced or metastatic urothelial cancer, and an approval in China may bring this therapy to those patients.”
The BLA submission for enfortumab vedotin is based on data from the Phase II EV-203 study, which showed that EV-203 met its primary endpoint, showing statistical significance in objective response rate (ORR).
Efficacy and pharmacokinetic data from the study are in line with global data, and EV-203 is a bridging study to EV-301, a Phase III randomised study that has supported global registrations of enfortumab vedotin, and EV-201 Cohort 1.
Globally, approximately 573,000 new cases of bladder cancer and 212,000 deaths are reported annually. Urothelial cancer accounts for 90% of all bladder cancers and can also be found in the renal pelvis, ureter and urethra. Approximately 12% of cases are locally advanced or metastatic urothelial cancer at diagnosis.
In China, the incidence rate of bladder cancer in 2020 ranked 12th among all cancers, with an estimated 85,649 new cases that year. The five-year prevalence of bladder cancer in China is estimated to be 16.26/100,000 cases, or 235,393 cases.