China's NMPA Approved Astellas Pharma's PADCEV™

China's NMPA Approved Astellas Pharma's PADCEV™

By, Admin 21 August 2024

China's NMPA Approved Astellas Pharma's PADCEV™ for Treating Locally Advanced or Metastatic Urothelial Cancer

Overview

Astellas Pharma has announced that China's National Medical Products Administration (NMPA) has approved PADCEV™ (enfortumab vedotin) for adult patients with locally advanced or metastatic urothelial cancer (la/mUC).

Enfortumab Vedotin will provide a new treatment option for patients who have already received platinum-based chemotherapy and PD-1/PD-L1 inhibitors.

Enfortumab Vedotin

  • Enfortumab vedotin is an ADC targeting Nectin-4, a protein found on the surface of certain cancer cells, particularly in bladder cancer. 
  • This approval expands the treatment options available to doctors, providing new hope for patients battling this challenging disease.

About the Approval

  • This approval is specifically for those who have previously undergone treatment with platinum-based chemotherapy and PD-1 or PD-L1 inhibitors.
  • The approval of enfortumab vedotin is a significant milestone. 
  • This decision, based on global and local studies, will now make this new antibody-drug conjugate (ADC) available to patients in China.

Urothelial Cancer

  • Urothelial cancer is a serious and aggressive condition that can affect both the lower and upper urinary tract, including the bladder and urethra, as well as the ureter and renal pelvis. 
  • In 2022, over 92,000 people in China were diagnosed with bladder cancer, resulting in around 41,000 deaths. 

The survival rates for those with locally advanced or metastatic urothelial cancer are particularly low, highlighting the need for new treatments.

Approval Based on Global EV-301 Trial

  • The approval is supported by data from the global EV-301 trial and the China-based EV-203 trial. 
  • The EV-203 trial, conducted in Chinese patients, confirmed the drug’s efficacy and safety, with the majority of treatment-related adverse events being mild to moderate. 
  • Astellas has already accounted for the financial impact of this approval in its forecast for the fiscal year ending March 31, 2025.

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