Padeliporfin
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[edit]
- 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.
Benefits[edit]
Vascular-targeted photodynamic therapy (VTP) with padeliporfin may allow tumor-site specific cytotoxicity while sparing adjacent normal tissues.
Indications[edit]
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[edit]
Padeliporfin was approved for use in the European Union in November 2017.
Status in the United States[edit]
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.
Brand name[edit]
Padeliporfin, sold under the brand name Tookad.
Cost[edit]
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
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