Padeliporfin Explained

Tradename:Tookad
Class:Antineoplastic agent
Atc Prefix:L01
Atc Suffix:XD07
Legal Uk:POM
Legal Uk Comment:[1]
Legal Eu:Rx-only
Legal Status:Rx-only
Cas Number:759457-82-4
Pubchem:56841556
Drugbank:DB15575
Unii:EEO29FZT86
Unii2:JQ72VD4XUL
Kegg:D10973
Synonyms:WST-09, WST-11
Iupac Name:3-[(2''S'',3''S'',12''R'',13''R'')-8-acetyl-13-ethyl-20-(2-methoxy-2-oxoethyl)-3,7,12,17-tetramethyl-18-(2-sulfoethylcarbamoyl)-2,3,12,13-tetrahydroporphyrin-22,24-diid-2-yl]propanoic acid;palladium(2+)
C:37
H:43
N:5
O:9
Pd:1
S:1
Smiles:CC[C@@H]1[C@H](C2=NC1=CC3=C(C(=C([N-]3)C(=C4[C@H]([C@@H](C(=N4)C=C5C(=C(C(=C2)[N-]5)C(=O)C)C)C)CCC(=O)O)CC(=O)OC)C(=O)NCCS(=O)(=O)O)C)C.[Pd+2]
Stdinchi:1S/C37H45N5O9S.Pd/c1-8-22-17(2)25-16-30-33(21(6)43)19(4)27(40-30)14-26-18(3)23(9-10-31(44)45)35(41-26)24(13-32(46)51-7)36-34(37(47)38-11-12-52(48,49)50)20(5)28(42-36)15-29(22)39-25;/h14-18,22-23H,8-13H2,1-7H3,(H5,38,39,40,41,42,43,44,45,47,48,49,50);/q;+2/p-2/t17-,18+,22-,23+;/m1./s1
Stdinchikey:MZRDSGWDVDESRC-VNWQTDIGSA-L

Padeliporfin, sold under the brand name Tookad, is a medication used to treat men with prostate cancer.[2] It is used in the form padeliporfin di-potassium.

The most common side effects include problems with urinating (pain, inability to pass urine, strong urge to pass urine, frequent urination, and incontinence), sexual problems (erectile dysfunction and ejaculation failure), blood in urine, urinary tract infection, and pain and bleeding around the genital area.

Padeliporfin was approved for medical use in the European Union in November 2017.

Medical uses

Padeliporfin is indicated as monotherapy for adults with previously untreated, unilateral, low risk, adenocarcinoma of the prostate with a life expectancy of at least ten years and clinical stage T1c or T2a; Gleason score ≤ 6, based on high-resolution biopsy strategies; prostate-specific antigen (PSA) ≤ 10ng/mL; three positive cancer cores with a maximum cancer core length of 5mm in any one core or 1-2 positive cancer cores with ≥ 50% cancer involvement in any one core or a PSA density ≥ 0.15ng/mL/cm3.

Society and culture

Legal status

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 (FDA) voted against approving padeliporfin di-potassium powder for solution for injection, submitted by Steba Biotech, S.A. 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.[3] [4]

Further reading

External links

Notes and References

  1. Web site: Tookad 183 mg powder for solution for injection - Summary of Product Characteristics (SmPC) . (emc) . 1 April 2020 . 20 March 2020 . https://web.archive.org/web/20200320131822/https://www.medicines.org.uk/emc/product/9366/smpc . live .
  2. Web site: Tookad EPAR . European Medicines Agency (EMA) . 29 November 2017 . 1 April 2020 . 20 October 2020 . https://web.archive.org/web/20201020041638/https://www.ema.europa.eu/en/medicines/human/EPAR/tookad . live . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  3. Web site: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement . U.S. Food and Drug Administration (FDA) . 26 February 2020 . 1 April 2020 . 2 April 2020 . https://web.archive.org/web/20200402015349/https://www.fda.gov/advisory-committees/advisory-committee-calendar/february-26-2020-meeting-oncologic-drugs-advisory-committee-meeting-announcement-02262020-02262020 . live .
  4. Web site: Landenberger . Lee . Too bad for Tookad: FDA adcom votes against Steba's prostate cancer treatment . BioWorld . 26 February 2020 . 1 April 2020 . 9 May 2021 . https://web.archive.org/web/20210509165457/https://www.bioworld.com/articles/433332-too-bad-for-tookad-fda-adcom-votes-against-stebas-prostate-cancer-treatment . live .