FDA approved nirogacestat for desmoid tumors in November 2023
The agency cleared OGSIVEO as the first approved treatment for adults with progressing desmoid tumors needing systemic therapy.
The Food and Drug Administration approved nirogacestat, sold as OGSIVEO by SpringWorks Therapeutics, Inc., on November 27, 2023. The approval covers adult patients with progressing desmoid tumors who require systemic treatment.1
The agency's record states this is the first approved treatment for desmoid tumors.1
The FDA's posting does not include additional detail on trial design, dosing regimen, or efficacy and safety data supporting the approval. Readers seeking those specifics should consult the full prescribing information or the agency's broader approval package, which is not part of this record.
No further regulatory actions, label updates, or post-marketing commitments tied to this approval are described in the available documentation as of this writing.
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.