Astellas Pharma Inc. (TYO: 4503), a leading Japanese pharmaceutical company, has announced that China’s Center for Drug Evaluation (CDE) has accepted for review a supplementary Biologic License Application (sBLA) for its drug Padcev (enfortumab vedotin). The application seeks to expand the use of Padcev in combination with pembrolizumab for the first-line treatment of patients with locally advanced or metastatic urothelial carcinoma (la/mUC). If approved, this combination therapy could become a groundbreaking alternative to the standard platinum-containing chemotherapy, which is currently the first-line treatment for la/mUC.
Padcev, a best-in-class antibody-drug conjugate (ADC) targeting Nectin-4, a protein highly expressed in bladder cancer cells, was fast-tracked for marketing in the US in December 2019 for the treatment of la/mUC in adults ineligible for cisplatin-containing chemotherapy. The drug received full approval in 2021 for this indication. However, the US FDA has also issued a black box warning for Padcev, indicating that it can cause serious and sometimes fatal skin adverse reactions, including Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), particularly during the first week of treatment .
The sBLA submission to the CDE is based on positive data from a Phase II trial, which showed that the combination of Padcev and pembrolizumab could significantly improve outcomes for patients with la/mUC. Astellas is now looking to bring this potential new treatment option to the Chinese market, where it could benefit a large patient population.- Flcube.com
