The European Commission (EC) has approved Astellas and Seagen’s padcev (enfortumab vedotin-ejfv) for the treatment of urothelial cancer, a bladder cancer type.
Padcev is indicated as a monotherapy to treat locally advanced or metastatic urothelial cancer adult patients who previously received a platinum-containing chemotherapy and a PD-1/L1 inhibitor.
The regulatory approval is supported by data obtained from the international Phase III EV-301 trial.
In the study, enfortumab vedotin was compared with chemotherapy in locally advanced or metastatic urothelial cancer adult patients who received a PD-1/L1 inhibitor and platinum-based chemotherapy earlier.
Findings showed that the patients treated with this therapy had an overall survival (OS) benefit compared to chemotherapy.
The most common adverse reactions observed in the clinical trials include peripheral sensory neuropathy, nausea, pruritus, dysgeusia, anemia, fatigue, decreased appetite, diarrhea, rash maculo-papular, dry skin, aspartate aminotransferase increased, hyperglycemia, alopecia, weight decrease, vomiting, dry eye, alanine aminotransferase increase and rash.
Astellas stated that the EV-301 trial data will be used to support global registrations for enfortumab vedotin.
Astellas Development Therapeutic Areas head, senior vice-president Ahsan Arozullah said: “The approval of enfortumab vedotin in the European Union is a significant milestone for people living with advanced urothelial cancer who have had limited treatment options and poor survival rates.
“We look forward to working with health authorities to ensure people living with advanced urothelial cancer can access this new treatment option as soon as possible.”
The company also noted that the marketing authorisation from the EC for enfortumab vedotin is applicable in the European Union (EU) Member States, and Norway, Liechtenstein, and Iceland.