It is a novel medication for treating men with low-risk prostate cancer, where the cancer affects only one side of the prostate and who have a life expectancy of at least ten years. It is a vascular-acting photosensitizer consisting of a water-soluble, palladium-substituted bacteriochlorophyll derivative with antineoplastic activity.
Mechanism of action
- Upon administration, paldeliporfin is activated locally when the tumor bed is exposed to low-power laser light.
- Reactive oxygen species (ROS) are formed upon activation and ROS-mediated necrosis may occur at the site of interaction between the photosensitizer, light and oxygen.
The proposed indication (use) for the product is for the treatment of men with localized prostate cancer, meeting the following criteria: Stage T1-T2a and prostate specific antigen less than or equal to 10 ng/mL and Gleason Grade Group 1 based on transrectal ultrasound guided biopsy or unilateral Gleason Grade Group 2 based on multiparametric magnetic resonance imaging-targeted biopsy with less than 50 percent of cores positive
Approval in the European Union
Padeliporfin was approved for use in the European Union in November 2017.
Status in the United States
In February 2020, the US Food and Drug Administration (FDA) voted against approving padeliporfin di-potassium powder solution for injection, submitted by Steba Biotech, S.A.
Padeliporfin, sold under the brand name Tookad.
The cost is considered to be prohibitive in the United States which is one of the reason's why the medication was not approved in the United States, according to NICE
Latest research - Padeliporfin
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