Research & Development
SpringWorks Therapeutics announces grant of FDA Fast Track designation for Nirogacestat to treat desmoid tumours in adult patients
7 November 2018 -

Clinical-stage biopharmaceutical company SpringWorks Therapeutics, a developer of medicines for patients with severe rare diseases and cancer, revealed on Wednesday that its gamma-secretase inhibitor Nirogacestat has received Fast Track designation from the US Food and Drug Administration (FDA).

SpringWorks Therapeutics said the FDA Fast Track program is designed to expedite the development and review of drugs with the potential to treat serious or life-threatening conditions and with nonclinical or clinical data that demonstrate the potential to address unmet medical needs. This designation enables a company to have frequent communication with the FDA throughout the drug development and review process.

Nirogacestat is an investigational, oral, small molecule, selective gamma-secretase inhibitor used to treat adult patients with progressive, unresectable, recurrent or refractory desmoid tumours or deep fibromatosis.

According to SpringWorks Therapeutics, desmoid tumors are rare and debilitating soft-tissue tumours that can occur in both children and adults. Depending on the size and location, desmoid tumours can cause severe morbidities such as pain, internal bleeding, disfigurement and limited range-of-motion. Desmoid tumours can be fatal if they impact vital organs.

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