Padeliporfin


Padeliporfin, sold under the brand name Tookad, is a 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.
Padeliporfin was approved for use in the European Union in November 2017. The active ingredient in Tookad is padeliporfin di-potassium.

History

Padeliporfin was approved for use in the European Union in November 2017.
In February 2020, the oncologic drugs advisory committee of the US Food and Drug Administration voted against approving padeliporfin di-potassium powder for solution for injection, submitted by Steba Biotech, S.A. The proposed indication 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.