FDA Fast Tracks Padeliporfin Immune Photo Activated Cancer Therapy for Upper-Tract Urothelial Cancer

A minimally invasive, targeted treatment option, ImPACT is also under evaluation in patients with other localized tumors, such as urothelial cancer, esophageal cancer, lung cancer, and pancreatic cancer.

The FDA has granted a fast track designation to padeliporfin Immune Photo Activated Cancer Therapy (ImPACT) for use in the treatment of patients with low-grade and unifocal upper-tract urothelial cancer (UTUC), according to an announcement from Steba Biotech.1 The decision follows the December 2020 clearance of an investigational new drug (IND) application for the treatment, with permitted the launch of a phase 3 trial examining padeliporfin ImPACT in patients with low-grade UTUC. Enrollment for the trial is anticipated to begin in Q1 2021.

“Momentum is building toward unlocking the significant potential for padeliporfin ImPACT in a range of solid tumors — first with the IND green light and now fast track designation,” Barak Palatchi, CEO of Staba Biotech, stated in a press release. “In the last 9 months, under the new leadership team, we have transformed the organization 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.”

A minimally invasive, targeted treatment option, ImPACT was approved for use in Europe, Israel, and Mexico in the treatment of patients with early-stage prostate cancer. The treatment approach is also under evaluation in patients with other localized tumors, such as urothelial cancer, esophageal cancer, lung cancer, and pancreatic cancer.

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