FDA approves SpringWorks Therapeutics’ Ogsiveo for treating desmoid tumors

SpringWorks Therapeutics Inc. (NASDAQ:SWTX), a Stamford-based commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced that the U.S. Food and Drug Administration (FDA) has approved Ogsiveo (nirogacestat), an oral gamma secretase inhibitor used by adult patients with progressing desmoid tumors who require systemic treatment.

Desmoid tumors are locally aggressive and invasive soft-tissue tumors that can be life-threatening. Although they do not metastasize, desmoid tumors are often refractory to existing off-label systemic therapies and associated with recurrence rates of up to 77% following surgical resection.

The FDA previously granted breakthrough therapy, fast track and orphan drug designations to Ogsiveo for the treatment of desmoid tumors.

“Our team is honored to deliver the first FDA-approved therapy for patients with desmoid tumors,” said Saqib Islam, CEO of SpringWorks. “This community has been waiting for an effective treatment that not only shrinks their tumors but also significantly improves pain, which is the most debilitating symptom reported by people living with desmoid tumors. We are pleased with the broad label, which includes all progressing adult patients and specifically references improvement in pain, and believe Ogsiveo has the potential to become the new standard of care for people living with these devastating tumors.”