US 11,925,619 B2
Treatments with nirogacestat
Allison Lim, Stamford, CT (US); Shinta Cheng, Stamford, CT (US); Todd Webster Shearer, Stamford, CT (US); Rex Williams, Stamford, CT (US); and Kristin Patterson, Stamford, CT (US)
Assigned to SPRINGWORKS THERAPEUTICS, INC., Stamford, CT (US)
Filed by SpringWorks Therapeutics, Inc., Stamford, CT (US)
Filed on Jul. 30, 2023, as Appl. No. 18/361,884.
Application 18/361,884 is a continuation of application No. 18/320,547, filed on May 19, 2023, granted, now 11,872,211.
Claims priority of provisional application 63/365,193, filed on May 23, 2022.
Claims priority of provisional application 63/365,125, filed on May 20, 2022.
Prior Publication US 2024/0033251 A1, Feb. 1, 2024
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/4164 (2006.01); A61P 35/00 (2006.01)
CPC A61K 31/4164 (2013.01) [A61P 35/00 (2018.01)] 16 Claims
 
1. A method for therapeutic treatment of desmoid tumor in a patient in need thereof comprising administering to the patient an oral dosage of nirogacestat or a pharmaceutically acceptable salt thereof, wherein the oral dosage provides upon initial oral administration to the patient a Cmax of less than 1000 ng/mL, wherein
the method comprises orally administering to the patient 150 mg (free base equivalent dose) of nirogacestat or a pharmaceutically acceptable salt thereof twice daily, and
the method further comprises upon the patient having an alanine transaminase (ALT) or aspartate aminotransferase (AST) of 3 to 5 times upper limit of normal (ULN), withholding the nirogacestat or pharmaceutically acceptable salt thereof until the ALT, AST, or both are resolved to no higher than 3 times ULN or baseline and then restarting oral administration of the nirogacestat or pharmaceutically acceptable salt thereof at a dose of 100 mg (free base equivalent dose) twice daily.