This review could potentially lead to the approval of the first combination treatment offering an alternative to platinum-containing chemotherapy as the first-line treatment for locally advanced or metastatic urothelial cancer (la/mUC) patients.
Platinum-based chemotherapy is the existing standard of care for first-line la/mUC.
Astellas filed the sNDA in January based on data from the Phase III EV-302 clinical trial, also called KEYNOTE-A39.
The randomised, open-label, controlled trial assessed PADCEV plus KEYTRUDA in comparison to the current standard of care in priorly untreated la/mUC patients.
It enrolled 886 patients eligible to receive cisplatin- or carboplatin-containing chemotherapy, irrespective of their PD-L1 status.
These subjects were randomised to receive either the PADCEV and KEYTRUDA combination or the standard chemotherapy.
Overall survival (OS) and progression-free survival (PFS) as per RECIST v1.1 by blinded independent central review (BICR) were the trial’s dual primary endpoints.
The combination therapy demonstrated statistically significant and clinically meaningful improvements in OS and PFS compared to the standard chemotherapy.
Moreover, the safety results were consistent with previous reports on this combination, with no new safety issues identified.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) is also reviewing the combination therapy, following its approval by the US Food and Drug Administration in December 2023.
Astellas Oncology Development head and senior vice-president Ahsan Arozullah said: “The MHLW’s priority review for our application for PADCEV in combination with pembrolizumab reflects the significance of the EV-302 trial findings and the urgent need for innovative new treatment options.
“We are pleased by this review designation and hope to quickly bring this treatment option to those who need it most.”