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SpringWorks’ Ogsiveo Is First-Ever US FDA-Approved Drug For Desmoid Tumors

Nirogacestat Also In Anti-BCMA Combo, Ovarian Cancer Studies

 
• By Mandy Jackson

SpringWorks’ gamma secretase inhibitor will be available soon for adults at any stage of treatment for desmoid tumors with a list price of $29,000 for a 30-day supply. 

FDA approved written on translucent black space
SpringWorks will file for approval in Europe next year • Source: Shutterstock

SpringWorks Therapeutics Inc. will soon launch its first product after the US Food and Drug Administration approved the small molecule gamma secretase inhibitor Ogsiveo (nirogacestat) for adults with progressing desmoid tumors who require systemic treatment. As the first-ever drug approved to treat the rare tumors, Ogsiveo appears poised to enjoy a warm welcome from doctors and patients who have been searching for alternatives to often ineffective surgeries and off-label medicines.

Key Takeaways

  • The US FDA approved Ogsiveo on 27 November to treat adults with progressing desmoid tumors who require systemic treatment. The drug will be available within five...

Stamford, CT-based SpringWorks, which plans to make the drug available in the US within five to 10 days of its 27 November approval, set a wholesale acquisition cost (WAC) for...

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