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.

What is claimed is: 
     
         1 . An approved drug product comprising apalutamide wherein such approved drug product improves metastasis free survival following administration to a male having non-metastatic castration resistant prostate cancer who is being treated with ongoing androgen deprivation therapy. 
     
     
         2 . The approved drug product of  claim 1 , wherein the median metastasis free survival is about 40.5 months. 
     
     
         3 . The approved drug product of  claim 2 , wherein the androgen deprivation therapy consists of orchiectomy or gonadotropin-releasing hormone agonists or antagonists. 
     
     
         4 . The approved drug product of  claim 1  that has an approved indication for non-metastatic castration resistant prostate cancer. 
     
     
         5 . The approved drug product of  claim 1  that is referenced listed on the basis of apalutamide administered orally at a dose of about 240 mg per day. 
     
     
         6 . The approved drug product of  claim 1  that is reference listed on the basis of apalutamide administered orally at a dose of about 60 mg four times per day. 
     
     
         7 . The approved drug product of  claim 1  that is present in a solid oral dosage form. 
     
     
         8 . The approve drug product of  claim 1  that is formulated as a tablet or capsule. 
     
     
         9 . The approved drug product of  claim 1 , wherein the approved drug product is an NDA drug product. 
     
     
         10 . An approved drug product that is bioequivalent to the approved drug product of  claim 1 . 
     
     
         11 . The approved drug product of  claim 10 , wherein the approved drug product is an ANDA drug product, a supplemental New Drug Application drug product, or a 505(b)(2) drug product. 
     
     
         12 . An approved drug product that comprises apalutamide and is reference listed on the basis of data demonstrating an improvement in metastasis free survival in a population of male humans with non-metastatic prostate cancer who received apalutamide in combination with androgen deprivation therapy relative to a population of male humans with non-metastatic prostate cancer who received a placebo. 
     
     
         13 . The approved drug product of  claim 12 , wherein the median metastasis free survival for the population of males who received apalutamide in combination with androgen deprivation therapy is about 40.5 months. 
     
     
         14 . The approved drug product of  claim 12  that has an approved indication for non-metastatic castration resistant prostate cancer. 
     
     
         15 . The approved drug product of  claim 12  that is referenced listed on the basis of apalutamide administered orally at a dose of about 240 mg per day. 
     
     
         16 . The approved drug product of  claim 12  that is reference listed on the basis of apalutamide administered orally at a dose of about 60 mg four times per day. 
     
     
         17 . The approved drug product of  claim 12 , wherein the androgen deprivation therapy consists of orchiectomy or gonadotropin-releasing hormone agonists or antagonists. 
     
     
         18 . The approved drug product of  claim 12  that is present in a solid oral dosage form. 
     
     
         19 . The approve drug product of  claim 12  that is formulated as a tablet or a capsule. 
     
     
         20 . The approved drug product of  claim 12 , wherein the approved drug product is an NDA drug product. 
     
     
         21 . An approved drug product that is bioequivalent to the approved drug product of  claim 12 . 
     
     
         22 . The approved drug product of  claim 21 , wherein the approved drug product is, an ANDA drug product, a supplemental New Drug Application drug product, or a 505(b)(2) drug product. 
     
     
         23 . An approved drug product with at least one approved indication, wherein said approved drug product comprises apalutamide. 
     
     
         24 . The approved drug product of  claim 23 , 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. 
     
     
         25 . The approved drug product of  claim 23 , wherein a reference listed drug product for the approved drug product includes a drug product label that comprises metastasis free survival data, wherein the metastasis free survival data for apalutamide in combination with androgen deprivation therapy arm has a median of about 40.5 months.