Policy & Regulation
Steba biotech receives US FDA Fast Track designation for padeliporfin IMmune Photo Activate Cancer Treatment
18 January 2021 -

Luxembourg-based Steba biotech has received Fast Track designation from the United States Food and Drug Administration (FDA) for padeliporfin IMmune Photo Activate Cancer Treatment (ImPACT) intended to treat adult patients with low-grade and unifocal high-grade Upper Tract Urothelial Cancer (UTUC), it was reported on Friday.

This move is subsequent to the approval of the Investigational New Drug (IND) application granted in December 2020 enabling the start of the phase three clinical trial of padeliporfin ImPACT in patients with low-grade UTUC, likely to commence enrolment in the first quarter of 2021.

Barak Palatchi, Steba CEO, said, 'Momentum is building towards unlocking the significant potential of padeliporfin ImPACT in a range of solid tumours – first with the IND green light and now Fast Track designation. In the last nine months, under the new leadership team, we have transformed the organisation with a bold strategy and focused execution. Achieving these important regulatory milestones in quick succession is a powerful acknowledgement of the technology and will accelerate the pace by which we can make padeliporfin ImPACT available for people living with cancer.'