Padcev, in combination with Keytruda (pembrolizumab), has been approved by the European Commission for the treatment of advanced urothelial carcinoma.
Astellas Pharmaceuticals' Padcev, or enfortumab vedotin, receieved this opinion through the positive results of the Phase III KEYNOTE-A39 trial, which found that the combination therapy nearly doubled patient median overall survival, while also extending progression-free survival when compared to chemotherapy alone.
Dr Thomas Powles of the Barts Cancer Institute Biomedical Research Centre, commented: “Having an effective new first-line treatment for advanced urothelial cancer is opening a long-awaited new chapter in the management of this usually fatal disease. The impressive effects of the treatment combination were clearly seen during the Phase III
clinical trial programme, and I look forward to seeing the treatment combination implemented as a first-line regimen in a clinical setting."
Astellas' Senior Vice President and the Head of Oncology, Ahsan Arozullah, added: “In line with the recent updates to European clinical guidelines, we are delighted that
the European Commission has approved enfortumab vedotin in combination with pembrolizumab as first-line treatment for patients with unresectable or metastatic
urothelial cancer. This approval is testament to our ongoing partnership with clinical trial investigators, study participants and their families, and the broader bladder cancer
community.”
Bladder cancer is currently the fith most commonly diagnosed cancer across Europe, and it kills more than 50,000 people per year in this region.
This is partly because patients are diagnosed late, with a large number of those suffering already presenting with advanced or metastatic disease — which has a significantly worse prognosis compared to earlier iterations of the disease.
The marketing authorisation given by the European Commission will now allow the treatment regimen to be used in the 27 EU member states, as well as Iceland, Liechtenstein and Norway.
This follows the approval of Padcev as a monotherapy by the European Commission, as well as in combination with Keytruda for urothelial carcinoma by the FDA.
