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Last Updated: December 17, 2025

Claims for Patent: 11,986,468

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Summary for Patent: 11,986,468

Title:	Methods of treating prostate cancer
Abstract:	Disclosed are methods of treating prostate cancer by administering niraparib to a human in need thereof.
Inventor(s):	Marco Gottardis, Rebecca Hawkins, Linda A. Snyder, Douglas H. Yamada
Assignee:	Janssen Pharmaceutica NV
Application Number:	US17/989,420
Patent Claims:	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 (a) is not BRCA deficient or (b) is carrying at least one DNA repair anomaly in a gene selected from the group consisting of FANCA, PALB2, CHEK2, BRIP1, HDAC2, and ATM. 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 antiandrogen therapy. 9. The method of claim 1, wherein the human is carrying at least one DNA repair anomaly selected from the group consisting of FANCA, PALB2, CHEK2, BRIP1, HDAC2, and ATM. 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 antiandrogen therapy. 14. The method of claim 1, wherein the human is not BRCA deficient. 15. The method of claim 14, wherein niraparib or a salt thereof is administered in an amount of from about 30 mg niraparib/day to about 400 mg niraparib/day. 16. The method of claim 14, wherein niraparib or a salt thereof is administered in an amount of about 300 mg niraparib/day. 17. The method of claim 14, wherein the human has had at least one line of taxane-based chemotherapy. 18. The method of claim 14, wherein the prostate cancer has been exposed to at least one line of enzalutamide-, apalutamide-, or abiraterone acetate-based antiandrogen therapy. 19. The method of claim 1, wherein the DNA repair anomaly is a genomic lesion. 20. The method of claim 19, wherein the genomic lesion is a homozygous deletion, heterozygous deletion plus deleterious mutation, copy neutral loss of heterozygosity plus deleterious mutation, or mono-allelic delirious mutation in the kinase catalytic domain. 21. The method of claim 1, further comprising determining whether the human (a) is not BRCA deficient or (b) is carrying at least one DNA repair anomaly in a gene selected from the group consisting of FANCA, PALB2, CHEK2, BRIP1, HDAC2, and ATM. 22. A method of treating prostate cancer in a human in need of such treatment comprising: determining whether the human (a) is not BRCA deficient or (b) is carrying at least one DNA repair anomaly in a gene selected from the group consisting of FANCA, PALB2, CHEK2, BRIP1, HDAC2, and ATM, and administering to the human a therapeutically acceptable amount of niraparib or a salt thereof to a human who not BRCA deficient or to a human who is carrying the at least one DNA repair anomaly, wherein the prostate cancer is antiandrogen resistant.

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