The European Commission (EC) has authorised ‘s PADCEV (enfortumab vedotin) in combination with KEYTRUDA (pembrolizumab) for first-line treatment of advanced urothelial cancer. This regimen is intended specifically for adults with unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy. The gold standard of business intelligence.
PADCEV is an antibody-drug conjugate while KEYTRUDA is a PD-1 inhibitor. The marketing authorisation extends to all 27 member states in the European Union (EU) along with Iceland, Liechtenstein and Norway. The decision follows the results from the Phase III EV-302 clinical trial (KEYNOTE-A39), which demonstrated that the combination of enfortumab vedotin plus pembrolizumab almost doubled the median overall survival (OS).
The combination regimen also significantly prolonged progression-free survival (PFS) when compared with platinum-containing chemotherapy. Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research.
Gain competitive edge. Your download email will arrive shortly We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form The median OS reached 31.
5 months with the combination therapy, a substantial increase from the 16.1 months observed with chemotherapy, equating to a 53% reduction in t.