The European Commission (EC) has authorised Astellas Pharma'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.
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.
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 the risk of death.
The median PFS was also extended to 12.5 months from 6.3 months - a 55% decrease in the risk of cancer progression or death.
Astellas is now engaging with local regulatory authorities and health technology assessment bodies across the EU to facilitate patient access to this treatment combination.
Astellas oncology development head and senior vice-president Ahsan Arozullah stated: “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. We look forward to patients across the European Union gaining benefit from this combination early in their treatment journey.”
The company recently received approval from the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) for PADCEV to treat locally advanced or metastatic urothelial cancer.
