The European Commission has granted marketing authorisation for antibody-drug conjugate (ADC) Padcev (enfortumab vedotin) in combination with PD-1 inhibitor Keytruda (pembrolizumab) for urothelial cancer. It is approved for the first-line treatment of adult patients with unresectable or metastatic cancer, who are eligible for platinum-containing chemotherapy. The approval is based on… Read More
Astellas has submitted a supplemental new drug application (sNDA) in Japan for Padcev (enfortumab vedotin (genetical recombination)) with Keytruda (pembrolizumab (genetical recombination)) for the first-line treatment of advanced bladder cancer. If approved, it would be the first combination in Japan to offer an alternative to chemotherapy, the current standard of… Read More
The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of erdafitinib for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible fibroblast growth factor receptor 3 (FGFR3)… Read More
