for desmoid tumors (locally aggressive soft-tissue tumors)
Sponsor announced submission APR 29 2026. FDA filing review (~60 days) in progress; PDUFA date estimated as acceptance + 10 months Standard Review. Card updates with confirmed dates when FDA acceptance announcement lands.
Desmoid tumors are rare, non-metastatic growths that form from connective tissue cells and can invade nearby organs, causing pain or life-threatening complications when they compress vital structures. Varegacestat is a pill that blocks gamma-secretase, an enzyme involved in cell signaling pathways that may fuel tumor growth. By interrupting this pathway, the drug could potentially slow the progression of these locally aggressive tumors and reduce their impact on surrounding tissues.
The current study is designed to evaluate the efficacy and safety of AL102 in patients with progressive desmoid tumors.
Source: ClinicalTrials.gov