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FDA grants Fast Track designation to novel treatment for UTUC


The investigational padeliporfin ImPACT platform involves the intravenous delivery of the photosensitive drug padeliporfin, which is then activated by a non-thermal light delivery system.

The FDA has granted a Fast Track designation to padeliporfin Immune Photo Activated Cancer Therapy (ImPACT) for the treatment of adult patients with low-grade and unifocal high-grade upper tract urothelial cancer (UTUC), according to Steba biotech, the developer of the investigational treatment.1

The padeliporfin ImPACT platform involves the intravenous delivery and activation of the photosensitive drug padeliporfin. The drug is delivered intravenously and is activated by a non-thermal light delivery system that uses a lower energy laser light channeled through optical fibers.”2 The minimally invasive approach enables targeted ablation of the tumor. The treatment was initially explored in prostate cancer and is now being investigated in UTUC and other solid tumors.

Padeliporfin ImPACT has shown positive initial efficacy in prostate cancer and a phase 1 UTUC trial. In December 2020, Steba received FDA clearance on an Investigational New Drug (IND) application, permitting the launch of a phase 3 study of padeliporfin ImPACT in patients with low-grade UTUC.

The FDA’s Fast Track designation is designed to expedite the review and development of novel treatments that will fill an unmet medical need.

"Momentum is building towards unlocking the significant potential of padeliporfin ImPACT in a range of solid tumors—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 organization with a bold strategy and focused execution,” Barak Palatchi, CEO of Steba, stated in a press release. “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 major breakthrough in the UTUC armamentarium came in April 2020 when the FDA approved Jelmyto (mitomycin gel) as the first therapy to treat low-grade UTUC.3

According to the FDA, UTUC includes a small subset of urothelial tumors that occur in the lining of the kidney or the ureter. The low-grade subtype of UTUC is most commonly noninvasive and confined to the kidney or ureter; however, these tumors frequently recur.

Overall about 6000 to 8000 new cases of low-grade UTUC occur annually in the United States. Despite the major breakthrough with Jelmyto, there remains a high unmet need for novel UTUC treatments.

"There is currently a high unmet medical need in UTUC, given the clinical aim to preserve the patient's kidney, rendering surgery as a last resort. Good initial efficacy data from the phase 1 clinical trial in patients with UTUC, coupled with strong safety and efficacy data previously obtained in prostate cancer, make us confident that padeliporfin ImPACT has the potential to be a well-tolerated, safe and efficacious treatment in UTUC and other cancer indications," Dr David Perry, head of Steba R&D, stated in the press release.


1. FDA Grants Fast Track Designation to Padeliporfin ImPACT for Steba biotech. Posted online January 17, 2020. Accessed January 19, 2021. https://prn.to/3sI4iOY.

2. Steba biotech. A Novel Treatment Path. Accessed January 19, 2021. https://www.stebabiotech.com/technology-innovation.

3. FDA Approves First Therapy for Treatment of Low-Grade Upper Tract Urothelial Cancer. Posted online April 15, 2020. Accessed January 19, 2021. https://bit.ly/2XUxWCD.

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