FDA grants fast track designation to padeliporfin ImPACT for urothelial cancer subset
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The FDA granted fast track designation to padeliporfin immune photo activated cancer treatment as treatment for adults with low-grade upper tract urothelial carcinoma.
The platform — known as padeliporfin ImPACT (Steba Biotech) — provides surgery-like efficacy with organ preservation, according to its developer. It allows for IV delivery of an inactive drug, padeliporfin. When activated, the drug triggers constriction of the blood supply in an illuminated area only, leading to targeted tumor necrosis that activates anti-tumor immunity, according to a Steba Biotech-issued press release.
Upper tract urothelial carcinoma accounts for 5% to 10% of urinary tract malignancies.
Enrollment is expected to begin soon for a phase 3 trial that will evaluate padeliporfin ImPACT for low-grade disease. Steba Biotech officials hope to bring the platform to market by 2023.
“There is currently a high unmet medical need in upper tract urothelial carcinoma, given the clinical aim to preserve the patient’s kidney, rendering surgery as a last resort,” David Perry, MD, head of research and development with Steba Biotech, said in the release. “Good initial efficacy data from the phase 1 clinical trial [of] patients with upper tract urothelial carcinoma, 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 upper tract urothelial carcinoma and other cancer indications.”
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