Methods of treating a Bruton's Tyrosine Kinase disease or disorder
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 a disease or disorder selected from the group consisting of B-cell non-Hodgkin's lymphoma, chronic lymphocytic leukemia and Waldenstrom's macroglobulinemia, the method comprising administering to a patient in need thereof a composition comprising a therapeutically effective amount of Compound 1:
or a pharmaceutically acceptable salt thereof, wherein the therapeutically effective amount is about 750 mg to about 1000 mg.
2. The method of claim 1 , wherein the therapeutically effective amount is about 750 mg.
3. The method of claim 1 , wherein the therapeutically effective amount is about 1000 mg.
4. The method of claim 2 , wherein the therapeutically effective amount is about 375 mg BID.
5. The method of claim 3 , wherein the therapeutically effective amount is about 500 mg BID.
6. The method of claim 1 , wherein Compound 1 is administered once a day (QD).
7. The method of claim 2 , wherein Compound 1 is administered once a day (QD).
8. The method of claim 3 , wherein Compound 1 is administered once a day (QD).
9. The method according to claim 1 , wherein the B-cell non-Hodgkin's lymphoma is indolent.
10. The method according to claim 9 , wherein the B-cell non-Hodgkin's lymphoma is selected from follicular lymphoma and marginal zone lymphoma.
11. The method according to claim 1 , wherein the B-cell non-Hodgkin's lymphoma is aggressive.
12. The method according to claim 11 , wherein the B-cell non-Hodgkin's lymphoma is selected from diffuse large B-cell lymphoma and mantle cell lymphoma.
13. The method according to claim 1 , wherein the composition is formulated as an oral dosage form.
14. The method according to claim 13 , wherein the composition is administered once a day.
15. The method according to claim 13 , wherein the composition is administered twice a day.
16. The method according to claim 14 or 15 , wherein the composition is administered for at least one 28-day cycle.
17. The method according to claim 16 , wherein the patient has failed at least one prior therapy.
18. The method according to claim 1 , wherein Compound 1 is in the form of a benzenesulfonic acid salt.
19. The method according to claim 18 , wherein the composition comprises from about 10% to about 50% N-(3-(5-fluoro-2-(4-(2-methoxyethoxy)phenylamino)pyrimidin-4-ylamino)phenyl)acrylamide besylate.
20. The method according to claim 19 , wherein the composition comprises about 10% N-(3-(5-fluoro-2-(4-(2-methoxyethoxy)phenylamino)pyrimidin-4-ylamino)phenyl)acrylamide besylate.
21. The method according to claim 19 , wherein the composition comprises about 42% N-(3-(5-fluoro-2-(4-(2-methoxyethoxy)phenylamino)pyrimidin-4-ylamino)phenyl)acrylamide besylate.
22. The method according to claim 1 , wherein the composition comprises from about 5% to about 15% by weight of wetting agent.
23. The method according to claim 19 , wherein the composition comprises about 10% by weight of wetting agent.
24. The method according to claim 22 or 23 , wherein the wetting agent is selected from poloxamer, polyoxyethylene ethers, polyoxyethylene sorbitan fatty acid esters, polyoxyethylene fatty acid esters, polyethylene glycol fatty acid esters, polyoxyethylene hydrogenated castor oil, polyoxyethylene alkyl ether, polysorbates, cetyl alcohol, glycerol fatty acid esters, polyoxymethylene stearate, sodium lauryl sulfate, sorbitan fatty acid esters, sucrose fatty acid esters, benzalkonium chloride, polyethoxylated castor oil, and docusate sodium.
25. The method according to claim 24 , wherein the wetting agent is a poloxamer.
26. The method according to claim 25 , wherein the poloxamer is poloxamer 407.