(Reuters) – The U.S. health regulator on Monday approved SpringWorks Therapeutics’ drug for treating adult patients with desmoid tumors, making it the first approved treatment for this type of non-cancerous soft-tissue growth.
Shares of the company were up about 15% after the bell.
The company expects the monotherapy nirogacestat, branded as Ogsiveo, to be available in the United States within 10 days of approval, CEO Saqib Islam had told Reuters ahead of the Food and Drug Administration’s decision.
Desmoid tumors are rare, abnormal non-cancerous growths that occur in connective tissues and are associated with a high rate of recurrence, with higher prevalence in females.
An estimated 1,650 people in the U.S. are diagnosed with desmoid tumors each year, according to data from the National Institutes of Health.
(Reporting by Pratik Jain and Christy Santhosh in Bengaluru; Editing by Shilpi Majumdar and Shailesh Kuber)
