PADCEV (enfortumab vedotin) - Urothelial carcinoma

The Committee deems that the clinical benefit of PADCEV (enfortumab vedotin) 20 mg and 30 mg powder for concentrate for solution for infusion is substantial “in combination with pembrolizumab, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma who are eligible for platinum-based chemotherapy”.

Considering:

• evidence of the superiority of PADCEV (enfortumab vedotin) in combination with pembrolizumab compared to platinum-based chemotherapy (gemcitabine + cisplatin or carboplatin), in a randomised, open-label phase 3 study in terms of overall survival (HR = 0.468; CI95%[0.376; 0.582]), and in progression-free survival (HR = 0.450; CI95% [0.3777; 0.538]);

and despite:

• the absence of improvement in terms of time to pain progression;
• a toxicity profile marked by the frequent occurrence of skin disorders, peripheral sensory neuropathy, and treatment discontinuations due to adverse events (39.8% versus 21.5%);
• the lack of evidence of an improvement in quality of life (exploratory endpoint);

The Committee deems that PADCEV (enfortumab vedotin) 20 mg and 30 mg powder for concentrate for solution for infusion provides a moderate clinical added value (CAV III) compared to platinum-based chemotherapy.