SpringWorks Therapeutics. has been granted a patent for a method of treating desmoid tumors using nirogacestat. The method involves a specific dosing regimen and management of adverse effects, including adjustments based on diarrhea, hypophosphatemia, hypokalemia, and liver enzyme levels. GlobalData’s report on SpringWorks Therapeutics gives a 360-degree view of the company including its patenting strategy. Buy the report here.
According to GlobalData’s company profile on SpringWorks Therapeutics, Personalized cancer vaccines was a key innovation area identified from patents. SpringWorks Therapeutics's grant share as of July 2024 was 15%. Grant share is based on the ratio of number of grants to total number of patents.
Method for treating desmoid tumors with nirogacestat
The granted patent US12036207B2 outlines a method for the therapeutic treatment of desmoid tumors in patients through the oral administration of nirogacestat, specifically at a dosage of 150 mg (free base equivalent) twice daily. The claims detail a structured approach to managing adverse reactions associated with the treatment. If a patient experiences severe side effects such as Grade 3 or 4 diarrhea, hypophosphatemia, hypokalemia, or elevated liver enzymes (ALT/AST), the administration of nirogacestat is to be temporarily withheld until the adverse effects are resolved to a Grade 1 level or baseline. Upon resolution, the dosage is adjusted to 100 mg twice daily. In cases of severe liver enzyme elevation (greater than 5 times ULN), treatment is to be permanently discontinued.
Additionally, the patent specifies that the method may be applicable to various patient profiles, including those with specific genetic mutations (e.g., APC or CTNNB1), intraabdominal or extraabdominal tumors, a family history of familial adenomatous polyposis, or those who have previously undergone treatment for refractory or recurrent disease. The claims also highlight the importance of monitoring the pharmacokinetics of nirogacestat, with specified ranges for maximum concentration (Cmax) and area under the curve (AUCtau) to ensure effective and safe treatment. This structured treatment protocol aims to balance therapeutic efficacy with the management of potential adverse reactions in patients with desmoid tumors.
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