Shots:
- The approval is based on the P-III EV-301 clinical trial evaluating Padcev vs CT in 608 patients with LA/mUC prior treated with Pt-based CT and a PD-1/L1 inhibitor
- The pre-specified interim analysis showed that patients treated with Padcev demonstrated an m-OS (12.9 vs 9.0mos.) with a median of 3.9mos. longer than those who received CT
- Padcev is the first ADC which is approved in Japan for UC. Additionally, nonclinical data showed an anticancer activity due to its binding to Nectin-4 expressing cells followed by internalization and release of anti-tumor agent MMAE into the cell that resulted in cell cycle arrest & cell death
Click here to read full press release/ article | Ref: Seagen | Image: Businesswire
The post Astellas and Seagen’s Padcev (enfortumab vedotin) Receive MHLW’s Approval for the Treatment of Radically Unresectable Urothelial Carcinoma first appeared on PharmaShots.
