Anti-Androgens For The Treatment Of Non-Metastatic Castration-Resistant Prostate Cancer

Abstract

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 - 44 . (canceled) 
     
     
         45 . An approved drug product comprising apalutamide. 
     
     
         46 . The approved drug product of  claim 45 , wherein the approved drug product is in a single unit dosage form. 
     
     
         47 . The approved drug product of  claim 45 , wherein the single unit dosage form is a tablet. 
     
     
         48 . The approved drug product of  claim 45 , wherein the single unit dosage form comprises about 60 mg of apalutamide. 
     
     
         49 . The approved drug product of  claim 45 , wherein the approved drug product is an NDA drug product, an ANDA drug product, a supplemental New Drug Application drug product, or a 505(b)(2) drug product. 
     
     
         50 . The approved drug product of  claim 45 , wherein a reference listed drug product for the approved drug product includes a drug product label. 
     
     
         51 . The approved drug product of  claim 45 , wherein the drug product label comprises metastasis free survival data. 
     
     
         52 . The approved drug product of  claim 45 , wherein the metastasis free survival data for apalutamide in combination with androgen deprivation therapy arm has a median of about 40.5 months. 
     
     
         53 . An approved drug product comprising about 60 mg of apalutamide. 
     
     
         54 . The approved drug product of  claim 53 , wherein the approved drug product is in a single unit dosage form. 
     
     
         55 . The approved drug product of  claim 53 , wherein the single unit dosage form is a tablet. 
     
     
         56 . The approved drug product of  claim 53 , wherein the approved drug product is an NDA drug product, an ANDA drug product, a supplemental New Drug Application drug product, or a 505(b)(2) drug product. 
     
     
         57 . The approved drug product of  claim 53 , wherein a reference listed drug product for the approved drug product includes a drug product label. 
     
     
         58 . The approved drug product of  claim 53 , wherein the drug product label comprises metastasis free survival data. 
     
     
         59 . The approved drug product of  claim 53 , wherein the metastasis free survival data for apalutamide in combination with androgen deprivation therapy arm has a median of about 40.5 months. 
     
     
         60 . An approved drug product comprising about 240 mg of apalutamide. 
     
     
         61 . The approved drug produce of  claim 60 , wherein the approved drug product is an NDA drug product, an ANDA drug product, a supplemental New Drug Application drug product, or a 505(b)(2) drug product. 
     
     
         62 . The approved drug produce of  claim 60 , wherein a reference listed drug product for the approved drug product includes a drug product label. 
     
     
         63 . The approved drug produce of  claim 60 , wherein the drug product label comprises metastasis free survival data. 
     
     
         64 . The approved drug produce of  claim 58 , wherein the metastasis free survival data for apalutamide in combination with androgen deprivation therapy arm has a median of about 40.5 months.