	US 12,226,418 B2
	Dosing regimen for the treatment of PI3K related disorders
Krishnaswamy Yeleswaram, Landenberg, PA (US); Albert Assad, Jersey City, NJ (US); and Xuejun Chen, Glen Mills, PA (US)
Assigned to Incyte Corporation, Wilmington, DE (US)
Filed by Incyte Corporation, Wilmington, DE (US)
Filed on May 31, 2019, as Appl. No. 16/428,056.
Claims priority of provisional application 62/773,612, filed on Nov. 30, 2018.
Claims priority of provisional application 62/714,448, filed on Aug. 3, 2018.
Claims priority of provisional application 62/679,556, filed on Jun. 1, 2018.
Prior Publication US 2019/0365764 A1, Dec. 5, 2019
Int. Cl. A61K 31/519 (2006.01); A61P 35/00 (2006.01)

CPC A61K 31/519 (2013.01) [A61P 35/00 (2018.01)]

45 Claims

1. A method of treating a disease in a patient, wherein said disease is associated with abnormal expression or activity of PI3Kδ kinase, the method comprising:

i) administering to the patient an inhibitor of PI3Kδ, which is 4-{3-[1-(4-amino-3-methyl-1H-pyrazolo[3,4-d]pyrimidin-1-yl)ethyl]-5-chloro-2- ethoxy-6-fluorophenyl}pyrrolidin-2-one, or a pharmaceutically acceptable salt thereof, in a first dosage that is about 3 mg/day to about 50 mg/day for a first period of time which is about 2 weeks to about 12 weeks; and

ii) administering to the patient a second dosage of the inhibitor of PI3Kδ which is less than the first dosage administered at the end of the first period of time and which is:

(a) about 2.5 mg/day or less; or

(b) about 50 mg/week or less;

and wherein the second dosage is administered for a second period of time which occurs after the first period of time.