Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012 The Breakthrough Designation is granted to […]readmore
Tags : PADCEV
Shots: The BT designation is based on P-Ib/II EV-103 study assessing Padcev + Keytruda (pembrolizumab) in patients with LA/ mUC who are unable to receive cisplatin-based CT treated in the 1L […]readmore
The PADCEV was evaluated in P-II EV-201 Trial to evaluate 125 patients locally advanced or metastatic urothelial cancer who received who received prior treatment with a PD-1 or PD-L1 inhibitor […]readmore