SpringWorks NDA Gets Priority Review for Desmoid Tumors

The FDA has granted priority review to SpringWorks Therapeutics’ new drug application (NDA) for nirogacestat, used to treat adults with desmoid tumors, which grow from connective tissue and are usually benign but often painful.

Nirogacestat inhibits the enzyme gamma secretase, which is being investigated for its role in the growth of desmoid tumors.

The investigational drug is in phase 3 clinical development for desmoid tumors and phase 2 clinical development for ovarian granulosa cell tumors, a rare form of ovarian cancer.

The agency’s target action date for the NDA for use in treating desmoid tumors is Aug. 27.