The European Medicines Agency (EMA) has validated for review a Type II variation application for Pfizer and Astellas Pharma’s PADCEV (enfortumab vedotin) with KEYTRUDA (pembrolizumab) as first-line therapy option for locally advanced or metastatic urothelial cancer (la/mUC).
The treatment is intended for usage in adults with priorly untreated la/mUC.
This development marks a significant step towards potentially offering an alternative to the current standard platinum-containing chemotherapy.
An antibody-drug conjugate (ADC), PADCEV targets Nectin-4, a protein overexpressed in bladder cancer.
The application is supported by data from the Phase III EV-302 clinical trial (KEYNOTE-A39). In the trial, PADCEV plus KEYTRUDA combination demonstrated to improve overall survival (OS) and progression-free survival (PFS) with statistically significant and clinically meaningful outcomes versus existing chemotherapy regimens.
Furthermore, PADCEV plus KEYTRUDA regimen’s safety profile was in line with priorly reported data without any new safety issues reported.
Pfizer Oncology chief development officer Roger Dansey said: “The EV-302 pivotal trial demonstrated the benefits of combining PADCEV with pembrolizumab for advanced bladder cancer.
“Patients with bladder cancer in Europe face poor outcomes at the advanced stage, and innovative therapies that extend survival are needed.
“This acceptance brings us closer to our mission: delivering breakthroughs that help address the unmet needs of patients and reshape the advanced urothelial cancer treatment landscape.”
The EMA’s Committee for Medicinal Products for Human Use (CHMP) and the European Commission (EC) are anticipated to provide opinions and decisions on the application within this year.
The US Food and Drug Administration has already approved this combination therapy in December last year, paving the way for its use in the region.
Astellas Oncology Development head and senior vice president Ahsan Arozullah said: “Patients in Europe need better treatment options for advanced stage urothelial cancer, and we look forward to working with the EMA on their review of the combination of enfortumab vedotin and pembrolizumab. If approved, the combination would be the first alternative to a chemotherapy-based treatment for this patient population.”