Claims for Patent: 9,492,471

Summary for Patent: 9,492,471

Title:	Methods of treating a disease or disorder associated with Bruton\'S Tyrosine Kinase
Abstract:	The present invention provides methods of treating, stabilizing or lessening the severity or progression of a disease or disorder associated with BTK.
Inventor(s):	Daniel; Tom (LaJolla, CA), Takeshita; Kenichi (New York, NY), Foon; Kenneth (Summit, NJ), Mei; Jay (North Wales, PA)
Assignee:	Celgene Avilomics Research, Inc. (Cambridge, MA)
Application Number:	14/084,190
Patent Claims:	1. A method of treating, stabilizing or lessening the severity or progression of a disease or disorder selected from the group consisting of chronic lymphocytic leukemia and small lymphocytic lymphoma in a patient, the method comprising administering to the patient in need thereof therapeutically effective amounts of each of Compound 1, or a pharmaceutically acceptable salt thereof, an anti-CD20 antibody and at least one additional therapeutic agent selected from fludarabine, cyclophosphamide and bendamustine, wherein the therapeutically effective amount of Compound 1 is about 750 mg to about 1000 mg per day, and wherein the patient has failed at least one prior therapy. 2. The method according to claim 1, wherein Compound 1 is administered twice a day. 3. The method according to claim 2, wherein Compound 1 is in the form of a benzenesulfonic acid salt. 4. The method according to claim 3, wherein Compound 1 is administered as an oral dosage form. 5. The method according to claim 3, wherein the anti-CD20 antibody is rituximab. 6. The method according to claim 3, wherein the anti-CD20 antibody is ofatumumab. 7. The method according to claim 5, wherein rituximab is administered once during a 28-day cycle. 8. The method according to claim 7, wherein rituximab is administered as an intravenous infusion. 9. The method according to claim 5, wherein each of Compound 1 and rituximab is administered for at least one 28-day cycle. 10. The method according to claim 1, wherein the therapeutically effective amount of Compound 1 is about 375 mg BID. 11. The method according to claim 1, wherein the therapeutically effective amount Compound 1 is about 500 mg BID. 12. The method according to claim 1, wherein the anti-CD20 antibody is rituximab. 13. The method according to claim 1, wherein the anti-CD20 antibody is ofatumumab. 14. The method according to claim 12, wherein the therapeutically effective amount of rituximab is about 375 mg/m.sup.2. 15. The method according to claim 12, wherein the therapeutically effective amount of rituximab is about 500 mg/m.sup.2. 16. The method according to claim 1, wherein Compound 1 is administered once a day.

Details for Patent 9,492,471

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	11/26/1997		2033-08-27
Idec Pharmaceuticals Corp.	RITUXAN	rituximab	Injection	103737	02/19/2002		2033-08-27
Novartis Pharmaceuticals Corporation	ARZERRA	ofatumumab	Injection	125326	10/26/2009		2033-08-27
Novartis Pharmaceuticals Corporation	ARZERRA	ofatumumab	Injection	125326	04/01/2011		2033-08-27