Two regulatory approvals for Astellas

In a news packed morning, Japanese drugmaker Astellas Pharma (TYO: 4503) today revealed two regulatory approvals.

First, Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved Padcev (enfortumab vedotin [genetical recombination]) with Merck & Co’s Keytruda (pembrolizumab [genetical recombination]) as a combination therapy for the first-line treatment of adult patients with radically unresectable urothelial carcinoma. This is the first approved combination treatment for radically unresectable urothelial carcinoma in Japan to offer an alternative to platinum-containing chemotherapy, the current standard of care for first-line treatment, aid Astellas.

The approval by the MHLW was supported by results from the Phase III EV-302 clinical trial (also known as KEYNOTE-A39) which explored the efficacy and safety of enfortumab vedotin in combination with pembrolizumab in patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC).