SpringWorks' Ogsiveo nabs first FDA approval for desmoid tumors
US biopharma SpringWorks Therapeutics (Nasdaq: SWTX) has won a landmark approval from the US Food and Drug Administration (FDA).
The regulator has approved Ogsiveo (nirogacestat), an oral gamma secretase inhibitor, for the treatment of adults with progressing desmoid tumors who require systemic treatment.
"Ogsiveo has the potential to become the new standard of care"This approval - which led to a 10% rise in Springworks’ share price on Monday - is based on positive data from the Phase III DeFi trial, in which Ogsiveo significantly improved progression-free survival and objective response rate, with rapid and sustained improvements in pain, physical functioning and overall quality of life.
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