IP Library › Granted Patent US 12,383,543
Granted Patent B2
US 12,383,543 · App. 17/528,017 · Granted Aug 12, 2025

Methods of treating prostate cancer

Inventors: Marco Gottardis (Princeton, NJ); Rebecca Hawkins (Harleysville, PA); Linda A. Snyder (Pottstown, PA); Douglas H. Yamada (Philadelphia, PA)
Assignee: Janssen Pharmaceutica NV
A61K31/454A61K9/0053A61P13/08A61P35/00A61P35/04
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Quick Facts
Patent No.
US 12,383,543
App. No.
17/528,017
Granted
Aug 12, 2025
Kind
B2
Abstract

Disclosed are methods of treating prostate cancer by administering niraparib to a human in need thereof.

Claims (22)

1. A method of treating prostate cancer in a human in need of such treatment comprising administering to the human a therapeutically effective amount of niraparib or a salt thereof, wherein the prostate cancer is antiandrogen resistant and wherein the human is carrying at least one DNA repair anomaly in a gene selected from the group consisting of BRCA-1 and BRCA-2.

2. The method of claim 1 , wherein the prostate cancer is castration-resistant prostate cancer.

3. The method of claim 1 , wherein the prostate cancer is metastatic castration-resistant prostate cancer.

4. The method of claim 1 , wherein niraparib or a salt thereof is administered in an amount of from about 30 mg niraparib/day to about 400 mg niraparib/day.

5. The method of claim 1 , wherein niraparib or a salt thereof is administered in an amount of about 300 mg niraparib/day.

6. The method of claim 5 , wherein niraparib or a salt thereof is administered orally, once daily, in 100 mg niraparib oral dosage forms.

7. The method of claim 1 , wherein the human has had at least one line of taxane-based chemotherapy.

8. The method of claim 1 , wherein the prostate cancer has been exposed to at least one line of enzalutamide-, apalutamide-, or abiraterone acetate-based chemotherapy.

9. A method of treating castration- and antiandrogen-resistant prostate cancer in a human comprising administering niraparib or a salt thereof in 100 mg niraparib oral dosage forms once daily to the human, wherein the human is carrying at least one DNA repair anomaly in a gene selected from the group consisting of BRCA-1 and BRCA-2.

10. The method of claim 9 , wherein niraparib or a salt thereof is administered in an amount of from about 30 mg niraparib/day to about 400 mg niraparib/day.

11. The method of claim 9 , wherein niraparib or a salt thereof is administered in an amount of about 300 mg niraparib/day.

12. The method of claim 9 , wherein the human has had at least one line of taxane-based chemotherapy.

13. The method of claim 9 , wherein the prostate cancer has been exposed to at least one line of enzalutamide-, apalutamide-, or abiraterone acetate-based chemotherapy.

14. The method of claim 1 , wherein niraparib or a salt thereof is administered in an amount of about 200 mg niraparib/day.

15. The method of claim 1 , wherein niraparib or a salt thereof is administered in an amount of about 50 mg niraparib/day.

16. The method of claim 1 , wherein the DNA repair anomaly is a genomic lesion.

17. The method of claim 14 , wherein the genomic lesion is a homozygous deletion, heterozygous deletion plus deleterious mutation, or copy neutral loss of heterozygosity plus deleterious mutation.

18. The method of claim 1 , further comprising determining whether the human is carrying at least one DNA repair anomaly in a gene selected from the group consisting of BRCA-1 and BRCA-2.

19. A method of treating prostate cancer in a human in need of such treatment comprising:

determining whether the human is carrying at least one DNA repair anomaly in a gene selected from the group consisting of BRCA-1 and BRCA-2, and

administering to the human a therapeutically effective amount of niraparib or a salt thereof to a human who is carrying the at least one DNA repair anomaly,

wherein the prostate cancer is antiandrogen resistant.

Continuity (5)
Continuation 16131772 · Sep 14, 2018
Continuation 15663082 · Jul 28, 2017
Provisional Application 62369239 · Aug 1, 2016
Provisional Application 62368466 · Jul 29, 2016
Related Publication 20220071979A1 · Mar 10, 2022
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