Anti-androgens for the treatment of non-metastatic castration-resistant prostate cancer
Described herein are methods of treating non-metastatic castrate-resistant prostate cancer using an approved drug product comprising apalutamide, enzalutamide or darolutamide. Also described here are drug products containing apalutamide enzalutamide or darolutamide, and methods of selling or offering for sale an anti-androgen drug product.
1. A method of improving metastasis free survival in a male human with nonmetastatic castration-resistant prostate cancer, said method comprising administering to said male human an approved drug product comprising apalutamide in combination with androgen deprivation therapy.
2. The method of claim 1 , wherein the median metastasis free survival is about 40.5 months.
3. A method of improving metastasis free survival in a male human with nonmetastatic castration-resistant prostate cancer, said method comprising providing to said male human an approved drug product comprising apalutamide in combination with androgen deprivation therapy, wherein the androgen deprivation therapy consists of orchiectomy or gonadotropin-releasing hormone agonists or antagonists.
4. The method of claim 1 , further comprising selling such approved drug product, wherein a drug product label for a reference listed drug for such approved drug product includes instructions for treating non-metastatic castration resistant prostate cancer.
5. The method of claim 1 , wherein a drug product label for a reference listed drug for such approved drug product comprises metastasis free survival data.
6. The method of claim 4 , wherein the drug product label comprises metastasis free survival data.
7. The method of claim 5 , wherein the metastasis free survival data for apalutamide in combination with androgen deprivation therapy arm has a median of about 40.5 months.
8. The method of claim 6 , wherein the metastasis free survival data for apalutamide in combination with androgen deprivation therapy arm has a median of about 40.5 months.
9. The method of claim 1 or 3 , wherein a drug product label for a reference listed drug for such approved drug product includes instructions for treating non-metastatic castration resistant prostate cancer.
10. The method of claim 3 , wherein the median metastasis free survival is about 40.5 months.