Claims for Patent: 11,077,106

Summary for Patent: 11,077,106

Title:	Cancer treatment
Abstract:	The present invention provides a method for the treatment of cancer with erdafitinib.
Inventor(s):	Stuyckens; Kim (Heist-op-den-berg, BE), Perez Ruixo; Juan Jose (Valencia, ES), De Porre; Peter Marie Z. (Sint-Denijs-Westrem, BE), Avadhani; Anjali Narayan (Chalfont, PA), Loriot; Yohann (Villejuif, FR), Siefker-Radtke; Arlene O. (Pearland, TX)
Assignee:	Janssen Pharmaceutica NV (Beerse, BE)
Application Number:	16/483,579
Patent Claims:	1. A method for the treatment of urothelial cancer harboring at least one FGFR genomic alteration, which method comprises: 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 subject on a treatment day during the first cycle of erdafitinib treatment; and c-1) when the serum phosphate levels are <5.5 mg/dL, erdafitinib is administered in an amount of 9 mg daily, on a continuous basis; or c-2) when the serum phosphate levels range from and including 5.5 mg/dL to <7 mg/dL, erdafitinib is further administered in an amount of 8 mg daily, on a continuous basis; or c-3) when the serum phosphate levels are .gtoreq.7 mg/dL, the erdafitinib treatment is interrupted temporarily. 2. The method of claim 1, wherein the 8 mg of erdafitinib is administered once daily. 3. The method of claim 1, wherein the serum phosphate levels of the subject measured on a treatment day during the first cycle of erdafitinib treatment are measured on day 14.+-.2 days of erdafitinib administration. 4. The method of claim 3, wherein the serum phosphate levels of the subject measured on a treatment day during the first cycle of erdafitinib treatment are measured on day 14 of erdafitinib administration. 5. The method of claim 1, wherein the 9 mg of erdafitinib is administered once daily. 6. The method of claim 1, wherein when the serum phosphate levels are .gtoreq.7 mg/dL, the erdafitinib treatment is interrupted temporarily until serum phosphate levels are <5.5 mg/dL. 7. The method of claim 1, wherein when the serum phosphate levels range from 7 mg/dL to .ltoreq.9 mg/dL, the erdafitinib treatment is interrupted temporarily until serum phosphate levels are <5.5 mg/dL and then erdafitinib treatment is re-started with 8 mg daily on a continuous basis. 8. The method of claim 1, wherein when the serum phosphate levels are >9 mg/dL, the erdafitinib treatment is interrupted temporarily until serum phosphate levels are <5.5 mg/dL and erdafitinib treatment is re-started at a lower dose. 9. The method of claim 8, wherein the lower dose is 6 mg daily on a continuous basis. 10. The method of claim 1, wherein when the serum phosphate levels are >10 mg/dL, the erdafitinib treatment is discontinued permanently. 11. The method of claim 1, wherein when the serum phosphate levels are >10 mg/dL, the erdafitinib treatment is interrupted temporarily until serum phosphate levels are <5.5 mg/dL and erdafitinib treatment is re-started at a lower dose. 12. The method of claim 1, wherein the at least one FGFR genomic alteration is an FGFR3-TACC3 translocation. 13. The method of claim 1, wherein the at least one FGFR genomic alteration is selected from the following FGFR3 gene mutations: FGFR3 R248C, FGFR3 S249C, FGFR3 G370C, and FGFR3 Y373C. 14. The method of claim 1, wherein the at least one FGFR genomic alteration is 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. 15. The method of claim 14, wherein the at least one FGFR genomic alteration is an FGFR3-TACC3 fusion. 16. The method of claim 1, wherein the urothelial cancer is metastatic or surgically unresectable urothelial cancer. 17. The method of claim 16, wherein the at least one FGFR genomic alteration is an FGFR3-TACC3 translocation. 18. The method of claim 16, wherein the at least one FGFR genomic alteration is selected from the following FGFR3 gene mutations: FGFR3 R248C, FGFR3 S249C, FGFR3 G370C, and FGFR3 Y373C. 19. The method of claim 16, wherein the at least one FGFR genomic alteration is 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. 20. The method of claim 1, wherein the amount of 8 mg of erdafitinib is administered as two formulations. 21. The method of claim 20, wherein the two formulations are two tablets, each comprising 4 mg of erdafitinib. 22. The method of claim 1, wherein the amount of 9 mg of erdafitinib is administered as three formulations. 23. The method of claim 22, wherein the three formulations are three tablets, each comprising 3 mg of erdafitinib.