Cancer Treatment

Abstract

The present invention provides a method for the treatment of cancer with erdafitinib.

1 - 15 . (canceled) 
     
     
         16 . A method comprising:
 a) administering to a subject in need thereof 8 mg of erdafitinib daily on a continuous basis;   b) measuring the serum phosphate levels of the patient on a treatment day during the first cycle of erdafitinib treatment;   c-1) when the serum phosphate levels are <7 mg/dL or when the serum phosphate levels range from and including 7 mg/dL to ≤9 mg/dL, erdafitinib is administered in an amount of 9 mg daily on a continuous basis; and when the serum phosphate levels range from and including 7 mg/dL to ≤9 mg/dL, concurrent treatment with a phosphate binder is optionally initiated; or   c-2) when the serum phosphate levels are >9 mg/dL, the erdafitinib treatment is interrupted temporarily.   
     
     
         17 . The method according to  claim 16 , wherein, when the serum phosphate levels are >9 mg/dL, the erdafitinib treatment is interrupted temporarily until serum phosphate levels are <7 mg/dL. 
     
     
         18 . The method according to  claim 17 , wherein, when the serum phosphate levels are >9 mg/dL, the erdafitinib treatment is interrupted temporarily until serum phosphate levels are <7 mg/dL and then erdafitinib treatment is re-started with 8 mg daily on a continuous basis. 
     
     
         19 . The method according to  claim 16 , wherein, when the serum phosphate levels are ≥10 mg/dL for >2 weeks, the erdafitinib treatment is interrupted permanently. 
     
     
         20 . The method according to  claim 16 , wherein 8 mg of erdafitinib is administered once daily. 
     
     
         21 . The method according to  claim 16  wherein 9 mg of erdafitinib is administered once daily. 
     
     
         22 . The method according to  claim 16 , wherein the serum phosphate levels of the patient are measured on day 14±2 days during the first cycle of erdafitinib treatment. 
     
     
         23 . The method according to  claim 22 , wherein the serum phosphate levels of the patient are measured on day 14 during the first cycle of erdafitinib treatment. 
     
     
         24 . The method according to  claim 16 , wherein concurrent treatment with a phosphate binder is initiated. 
     
     
         25 . The method according to  claim 16 , wherein the subject has a cancer harboring FGFR genomic alterations. 
     
     
         26 . The method according to  claim 25 , wherein the alterations are selected from the following fusions FGFR3:TACC3 v1; FGFR3:TACC3 v3; FGFR3:TACC3 Intron; FGFR3:BAIAP2L1; FGFR2:AFF3; FGFR2:BICC1; FGFR2:CASP7; FGFR2:CCDC6 and FGFR2:OFD1. 
     
     
         27 . The method according to  claim 25  wherein the alteration is a FGFR3-TACC3 fusion. 
     
     
         28 . The method according to  claim 25 , wherein the cancer is bladder cancer with FGFR3-TACC3 translocation, or urothelial cancer with FGFR3-TACC3 translocation, or metastatic or surgically unresectable urothelial cancer with FGFR3-TACC3 translocation. 
     
     
         29 . The method according to  claim 25 , wherein the alterations are selected from the following FGFR3 gene mutations: FGFR3 R248C, FGFR3 S249C, FGFR3 G370C, FGFR3 Y373C. 
     
     
         30 . The method according to  claim 25 , wherein the cancer is bladder cancer or urothelial cancer or metastatic or surgically unresectable urothelial cancer harboring at least one of the following FGFR3 gene mutations: FGFR3 R248C, FGFR3 S249C, FGFR3 G370C, FGFR3 Y373C. 
     
     
         31 . The method according to  claim 16 , wherein 8 mg of erdafitinib is to be administered as two formulations. 
     
     
         32 . The method according to  claim 31 , wherein the two formulations are two tablets, each comprising 4 mg of erdafitinib. 
     
     
         33 . The method according to  claim 16 , wherein 9 mg of erdafitinib is to be administered as three formulations. 
     
     
         34 . The method according to  claim 33 , wherein the three formulations are three tablets, each comprising 3 mg of erdafitinib.