METHODS OF TREATING A DISEASE OR DISORDER ASSOCIATED WITH BRUTON'S TYROSINE KINASE
The present invention provides methods of treating, stabilizing or lessening the severity or progression of a disease or disorder associated with BTK.
1 . A method of treating, stabilizing or lessening the severity or progression of one or more diseases and conditions associated with BTK comprising administering to a patient in need thereof. Compound 1 (N-(3-(5-fluoro-2-(4-(2-methoxyethoxy)phenylamino)pyrimidin-4-ylamino)phenyl)acrylamide):
or a pharmaceutically acceptable salt thereof, and lenalidomide.
2 . The method according to claim 1 , wherein the disease or condition associated with BTK is selected from chronic lymphocytic leukemia and small lymphocytic lymphoma.
3 . The method according to claim 2 , wherein Compound 1 is administered twice a day.
4 . The method according to claim 3 , wherein Compound 1 is in the form of a benzenesulfonic acid salt.
5 . The method according to claim 4 , wherein lenalidomide is administered once a day.
6 . The method of claim 5 , wherein each of Compound 1 and lenalidomide is administered as an oral dosage form.
7 . The method according to claim 6 , wherein each of Compound 1 and lenalidomide is administered for at least one 28-day cycle.
8 . The method according to claim 2 , wherein the patient has failed at least one prior therapy.
9 . The method according to claim 4 , wherein Compound 1 is administered in the form of a composition comprising from about 10% to about 50% N-(3-(5-fluoro-2-(4-(2-methoxyethoxy)phenylamino)pyrimidin-4-ylamino)phenyl)acrylamide besylate.
10 . The method according to claim 9 , wherein the composition comprises about 42% N-(3-(5-fluoro-2-(4-(2-methoxyethoxy)phenylamino)pyrimidin-4-ylamino)phenyl)acrylamide besylate.
11 . A method of preventing, 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, the method comprising administering to a patient in need thereof a therapeutically effective amount of Compound 1, or a pharmaceutically acceptable salt thereof, and a therapeutically effective amount of lenalidomide, wherein the therapeutically effective amount of Compound 1 is about 750 mg to about 1000 mg per day.
12 . The method according to claim 11 , wherein the therapeutically effective amount of Compound 1 is about 375 mg BID.
13 . The method according to claim 11 , wherein the therapeutically effective amount Compound 1 is about 500 mg BID.
14 . The method according to claim 11 , wherein lenalidomide is administered once a day (QD).
15 . The method according to claim 14 , wherein the therapeutically effective amount of lenalidomide is about 5 mg.
16 . The method according to claim 14 , wherein the therapeutically effective amount of lenalidomide is about 10 mg.
17 . A system for treating, stabilizing or lessening the severity of one or more diseases or conditions associated with BTK, the system comprising Compound 1, or a pharmaceutically acceptable salt thereof, and lenalidomide.