Pfizer and Astellas Pharma seek approval for Padcev with Keytruda as the first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer
Pfizer and Astellas seek EC approval for Padcev with Keytruda in urothelial cancer. (Credit: Pfizer Inc.)
Pfizer and Astellas Pharma said that the European Medicines Agency (EMA) has accepted to review a Type 2 variation application for Padcev (enfortumab vedotin) with Keytruda (pembrolizumab) as a combination therapy to treat certain bladder cancer.
Both firms seek approval for Padcev with Keytruda as the first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC).
If authorised, the combination therapy will offer an alternative to platinum-containing chemotherapy in the European Union (EU), which is the current standard of care in first-line la/mUC.
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 Type 2 variant application for the combination’s first-line use was based on the open-label, randomised, controlled Phase 3 EV-302 clinical trial results.
In 886 patients with previously untreated la/mUC, the combination was observed to improve overall survival (OS) and progression-free survival (PFS) with statistically significant and clinically meaningful effects when compared to platinum-containing treatment.
There were no new safety concerns found, and the safety results were in line with those that had previously been reported with the combination.
The European Commission (EC) and the EMA’s Committee for Medicinal Products for Human Use (CHMP) are anticipated to provide their opinions regarding the application this year.
The combination therapy was approved by the US Food and Drug Administration in December of 2023.
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.”