Posted by Michael Wonder on 15 Jan 2021
FDA grants fast track designation to padeliporfin ImPACT for Steba biotech
15 January 2021 - Ambitious development program for multiple solid tumours with high unmet need, starting with low grade upper tract urothelial cancer.
Steba biotech announced today that the U.S. FDA has granted fast track designation for padeliporfin ImPACT for the treatment of adult patients with low-grade and unifocal high-grade upper tract urothelial cancer.
This swiftly follows clearance of the Investigational New Drug application granted in December 2020 allowing initiation of the pivotal Phase 3 clinical trial of padeliporfin ImPACT in patients with low-grade urothelial cancer, expected to begin enrolment in Q1 2021.
