SFT is a rare cancer for which patients with locally advanced unresectable or metastatic disease have limited treatment options. [²¹²Pb]PSV359 is an investigational FAP-targeted alpha-particle therapy being evaluated in an ongoing Phase 1/2a study in patients with advanced FAP-positive solid tumors. Published clinical imaging research has demonstrated FAP-targeted tracer uptake in SFTs, supporting the biological rationale for evaluating a FAP-directed therapy in this disease.1 Early human imaging data for PSV359 support strong tumor uptake and fast renal clearance.

The FDA’s Fast Track program is intended to facilitate development and expedite the review of therapies for serious conditions with unmet medical needs.2 Programs that receive Fast Track Designation may benefit from more frequent interactions with the FDA regarding the development program. A Fast Track-designated product may also qualify for rolling review, Accelerated Approval, or Priority Review if the applicable requirements for those programs are met.2 FDA treats these as distinct expedited programs with separate qualifying criteria.