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# Parabilis’ FOG-001 Wins FDA Fast Track for Desmoid Tumors
- URL: https://www.fdaweb.com/parabilis-fog-001-wins-fda-fast-track-for-desmoid-tumors/
- Published: 2025-11-14T12:00:00.000Z
- Updated: 2026-09-14T15:26:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160224

FDA has granted Parabilis Medicines a fast track designation for FOG-001, a first-in-class inhibitor targeting the β-catenin:TCF interaction, for treating desmoid tumors. The action is based on the company’s early clinical data showing signs of meaningful antitumor activity.

In an ongoing Phase 1-2 study, 12 desmoid tumor patients had received FOG-001 as of the August cutoff, and tumor shrinkage was observed in all evaluable, according to the company. It says the therapy contributed to an 80% objective response rate among those with more than one post-baseline scan. Responses appeared independent of tumor location, prior gamma-secretase inhibitor exposure, or specific APC/CTNNB1 mutations. Parabilis also says there were no reported Grade 4/5 treatment-related events, discontinuations, or high-grade GI or skin toxicities.

Parabilis is also exploring FOG-001 across a range of other Wnt/β-catenin–driven tumors, including adamantinomatous craniopharyngioma, ameloblastoma, salivary gland cancers, and solid pseudopapillary neoplasm, with combination-therapy investigations planned for more complex cancers such as microsatellite-stable colorectal cancer. More data are expected in 2026, it adds.