Claims for Patent: 8,999,999

Summary for Patent: 8,999,999

Title:	Use of inhibitors of Bruton\'s tyrosine kinase (Btk)
Abstract:	Disclosed herein are methods for treating a cancer comprising: a. administering a Btk inhibitor to a subject sufficient to result in an increase or appearance in the blood of a subpopulation of lymphocytes defined by immunophenotyping; b. determining the expression profile of one or more biomarkers from one or more subpopulation of lymphocytes; and c. administering a second agent based on the determined expression profile.
Inventor(s):	Buggy; Joseph J. (Mountain View, CA), Elias; Laurence (Berkeley, CA), Fyfe; Gwen (San Francisco, CA), Hedrick; Eric (Summit, NJ), Loury; David J. (San Jose, CA), Mody; Tarak D. (Sunnyvale, CA)
Assignee:	Pharmacyclics, Inc. (Sunnyvale, CA)
Application Number:	13/747,322
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,999,999
Patent Claims:	1. A method for treating relapsed or refractory chronic lymphocytic leukemia or relapsed or refractory small lymphocytic leukemia in an individual comprising administering to the individual in need thereof once per day between about 280 mg to about 840 mg of an oral dose of an irreversible inhibitor of Bruton's tyrosine kinase (Btk), having the structure: ##STR00047## 2. The method of claim 1, wherein the subject has high risk relapsed or refractory chronic lymphocytic leukemia. 3. The method of claim 1, wherein the subject has nucleic acid deletion in chromosome 17. 4. The method of claim 3, wherein the deletion is in 17p. 5. The method of claim 4, wherein the deletion is in 17p13. 6. The method of claim 1, wherein the subject has nucleic acid deletion in chromosome 11. 7. The method of claim 6, wherein the deletion is in 11q. 8. The method of claim 7, wherein the deletion is in 11q22. 9. The method of claim 1, further comprising administering to the individual an additional cancer treatment regimen. 10. The method of claim 9, wherein the additional cancer treatment regimen comprises bendamustine, bortezomib, CAL-101, chlorambucil, cyclophosphamide, dexamethasone, docetaxel, doxorubicin, endostatineverolimus, etoposide, fludarabine, fostamatinib, hydroxydaunorubicin, ibritumomab, ifosphamide, lenalidomide, mesalazine, ofatumumab, paclitaxel, pentostatin, prednisone, rituximab, temsirolimus, thalidomide, tositumomab, vincristine, or a combination thereof. 11. The method of claim 1, further comprising administering to the individual rituximab. 12. The method of claim 1, further comprising administering to the individual bendamustine. 13. The method of claim 1, further comprising administering to the individual rituximab and bendamustine. 14. The method of claim 1, further comprising administering to the individual rituximab, fludarabine and cyclophosphamide. 15. The method of claim 1, further comprising administering to the individual rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone. 16. The method of claim 1, wherein the Btk inhibitor is administered orally. 17. The method of claim 1, wherein the Btk inhibitor is in the form of a solid oral dosage form. 18. The method of claim 1, wherein the once per day oral dose of the Btk inhibitor administered is about 280 mg/day, about 420 mg/day, about 560 mg/day, or about 840 mg/day.

Details for Patent 8,999,999

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	11/26/1997		2030-06-03
Idec Pharmaceuticals Corp.	RITUXAN	rituximab	Injection	103737	02/19/2002		2030-06-03
Glaxosmithkline Llc	BEXXAR	tositumomab and iodine i-131 tositumomab	Injection	125011	06/27/2003		2030-06-03
Novartis Pharmaceuticals Corporation	ARZERRA	ofatumumab	Injection	125326	10/26/2009		2030-06-03