Astellas Pharma Announces Approval of PADCEVTM with KEYTRUDA® for Advanced Bladder Cancer Treatment
Thursday, January 09, 2025
Astellas Pharma has confirmed that China’s National Medical Products Administration (NMPA) has approved the use of PADCEVTM (enfortumab vedotin) in combination with KEYTRUDA® (pembrolizumab) for the treatment of adults with locally advanced or metastatic urothelial cancer (la/mUC).
Bladder cancer, predominantly urothelial cancer, originates in the lining of the urinary system and is particularly challenging to treat when advanced. In China, bladder cancer ranks 11th among all cancers, with a five-year prevalence rate of 2.5 per 100,000 cases.
The significant cost of ongoing care makes it one of the most expensive cancers to manage over a patient’s lifetime.
This milestone introduces a new therapeutic option in China, offering an alternative to the platinum-based chemotherapy that has been the standard of care for decades.
Bladder cancer poses a significant health burden in China, with over 92,000 new cases diagnosed and approximately 41,000 deaths reported in 2022. Urothelial cancer, which represents the majority of bladder cancer cases, is frequently aggressive and associated with poor survival outcomes, particularly when diagnosed at advanced stages.
The newly approved combination therapy is expected to improve treatment outcomes for a wide range of patients, irrespective of biomarker status, cisplatin eligibility, or liver metastases.
The approval is based on data from the Phase 3 EV-302 clinical trial (KEYNOTE-A39), which demonstrated a significant improvement in overall survival (OS) and progression-free survival (PFS) compared to platinum-based chemotherapy.
Patients treated with the combination achieved a median OS of 31.5 months, compared to 16.1 months with chemotherapy. The median PFS was 12.5 months, significantly higher than the 6.3 months observed with chemotherapy.
These results reflect a notable reduction in the risk of death and disease progression, with consistent safety outcomes and no new safety concerns identified.
This approval marks the first non-platinum-based first-line treatment for advanced urothelial cancer in China and is expected to redefine the standard of care for this challenging condition. Astellas has already accounted for the financial impact of this approval in its fiscal forecast for the year ending March 2025.
For further information, refer to Astellas’ earlier announcement on this therapy’s regulatory submission in China, issued in March 2024.
Source: astellas.com
