Claims for Patent: 10,220,072

Summary for Patent: 10,220,072

Title:	Mesalamine for the treatment of cancer
Abstract:	Methods of treating renal cancer, including renal cell carcinoma, using mesalamine are disclosed herein. Mesalamine can be administered as a monotherapy or as part of a comprehensive treatment program, which can also include administration with other anti-cancer drugs, surgical treatments or exposure to ionizing radiation.
Inventor(s):	Malhotra; Geena (Mumbai, IN), Joshi; Kalpana (Maharashtra, IN), Ghosalkar; Jeevan (Thane, IN)
Assignee:	Cipla Limited (Mumbai, IN)
Application Number:	15/833,430
Patent Claims:	1. A method for the treatment of renal cell carcinoma in a patient, the method comprising administering to said patient mesalamine, or a pharmaceutically acceptable salt or prodrug thereof, in an amount effective to treat renal cell carcinoma, and at least one additional anti-cancer agent. 2. The method according to claim 1, wherein the additional anti-cancer agent comprises a nucleoside analog, antifolate, antimetabolite, topoisomerase I inhibitor, anthracycline, podophyllotoxin, taxane, vinca alkaloid, alkylating agent, platinum compound, proteasome inhibitor, nitrogen mustard, oestrogen analogue, monoclonal antibody, tyrosine kinase inhibitor, mTOR inhibitor, retinoid, immunomodulatory agent, histone deacetylase inhibitor, or a combination thereof. 3. The method according to claim 1, wherein the additional anti-cancer agent comprises nelarabine, azacitidine, capecitabine, fluorouracil, cytarabine, decitabine, gemcitabine, or a combination thereof. 4. The method according to claim 1, wherein the additional anti-cancer agent comprises afatinib, alectinib, axitinib, bosutinib, cabozantinib, dasatinib, erlotinib, lapatinib, lenvatinib, sorafenib, nilotinib, osimertinib, ponatinib, crizotinib, gefitinib, cobimetinib, sunitinib, trametinib, vandetanib, ceritinib, idelalisib, ruxolitinib, everolimus, temsirolimus, or a combination thereof. 5. The method according to claim 1, wherein the additional anti-cancer agent comprises bortezomib, ixazomib, brentuximab, alemtuzumab, ofatumumab, bevacizumab, tositumomab, blinatumomab, cetuximab, ramucirumab, daratumumab, denosumab, dinutuximab, elotuzumab, obinutuzumab, gemtuzumab, trastuzumab, ibritumomab, ipilimumab, necitumumab, nivolumab, panitumumab, pembrolizumab, pertuzumab, rituximab, atezolizumab or a combination thereof. 6. The method according to claim 4, wherein the additional anti-cancer agent comprises sunitinib maleate. 7. The method according to claim 1, wherein the at least one additional agent is administered simultaneously with mesalamine. 8. The method according to claim 1, wherein the at least one additional agent is administered sequentially with mesalamine. 9. The method according to claim 1, wherein the at least one additional agent is administered separately from mesalamine. 10. A pharmaceutical composition comprising mesalamine, or a pharmaceutically acceptable salt or prodrug thereof, and at least one additional renal cell carcinoma therapeutic agent, wherein the additional anti-cancer agent comprises a nucleoside analog, antifolate, antimetabolites, topoisomerase I inhibitor, anthracyclines, podophyllotoxin, taxane, vinca alkaloid, alkylating agent, platinum compound, proteasome inhibitor, nitrogen mustard, oestrogen analogue, monoclonal antibody, tyrosine kinase inhibitor, mTOR inhibitor, retinoid, immunomodulatory agent, histone deacetylase inhibitor, other kinase inhibitor or combinations thereof. 11. The composition according to claim 10, wherein the additional anti-cancer agent comprises nelarabine, azacitidine, capecitabine, fluorouracil, cytarabine, decitabine, gemcitabine, or a combination thereof. 12. The composition according to claim 10, wherein the additional anti-cancer agent comprises afatinib, alectinib, axitinib, bosutinib, cabozantinib, dasatinib, erlotinib, lapatinib, lenvatinib, sorafenib, nilotinib, osimertinib, ponatinib, crizotinib, gefitinib, cobimetinib, sunitinib, trametinib, vandetanib, ceritinib, idelalisib, ruxolitinib, everolimus, temsirolimus, or a combination thereof. 13. The composition according to claim 10, wherein the additional anti-cancer agent comprises bortezomib, ixazomib, brentuximab, alemtuzumab, ofatumumab, bevacizumab, tositumomab, blinatumomab, cetuximab, ramucirumab, daratumumab, denosumab, dinutuximab, elotuzumab, obinutuzumab, gemtuzumab, trastuzumab, ibritumomab, ipilimumab, necitumumab, nivolumab, panitumumab, pembrolizumab, pertuzumab, rituximab, atezolizumab or a combination thereof. 14. The composition according to claim 12, wherein the additional anti-cancer agent comprises sunitinib maleate. 15. A kit comprising mesalamine, or a pharmaceutically acceptable salt or prodrug thereof, and at least one additional renal cell carcinoma therapeutic agent, wherein the additional anti-cancer agent comprises a nucleoside analog, antifolate, antimetabolites, topoisomerase I inhibitor, anthracyclines, podophyllotoxin, taxane, vinca alkaloid, alkylating agent, platinum compound, proteasome inhibitor, nitrogen mustard, oestrogen analogue, monoclonal antibody, tyrosine kinase inhibitor, mTOR inhibitor, retinoid, immunomodulatory agent, histone deacetylase inhibitor, other kinase inhibitor or combinations thereof. 16. The kit according to claim 15, wherein the additional anti-cancer agent comprises nelarabine, azacitidine, capecitabine, fluorouracil, cytarabine, decitabine, gemcitabine, or a combination thereof. 17. The kit according to claim 15, wherein the additional anti-cancer agent comprises afatinib, alectinib, axitinib, bosutinib, cabozantinib, dasatinib, erlotinib, lapatinib, lenvatinib, sorafenib, nilotinib, osimertinib, ponatinib, crizotinib, gefitinib, cobimetinib, sunitinib, trametinib, vandetanib, ceritinib, idelalisib, ruxolitinib, everolimus, temsirolimus, or a combination thereof. 18. The kit according to claim 15, wherein the additional anti-cancer agent comprises bortezomib, ixazomib, brentuximab, alemtuzumab, ofatumumab, bevacizumab, tositumomab, blinatumomab, cetuximab, ramucirumab, daratumumab, denosumab, dinutuximab, elotuzumab, obinutuzumab, gemtuzumab, trastuzumab, ibritumomab, ipilimumab, necitumumab, nivolumab, panitumumab, pembrolizumab, pertuzumab, rituximab, atezolizumab or a combination thereof. 19. The kit according to claim 17, wherein the additional anti-cancer agent comprises sunitinib maleate. 20. The kit according to claim 15, wherein the mesalamine is provided in a pharmaceutical composition suitable for oral or parenteral administration.

Details for Patent 10,220,072

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	11/26/1997		2036-06-30
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998		2036-06-30
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017		2036-06-30
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948	05/07/2001		2036-06-30
Genzyme Corporation	LEMTRADA	alemtuzumab	Injection	103948	11/14/2014		2036-06-30
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948	10/12/2004		2036-06-30