FDA grants Fast Track status to Perspective's PSV359 for solitary fibrous tumors

Perspective Therapeutics, Inc. announced on October 8, 2026 that the FDA granted Fast Track Designation for the development of PSV359 for adult patients with locally advanced unresectable and/or metastatic fibroblast activation protein (FAP)-positive solitary fibrous tumors (SFTs).¹

The company noted that SFT is a rare cancer for which patients with locally advanced unresectable or metastatic disease have limited treatment options.¹ The drug candidate, [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.¹

Supporting the scientific rationale, the company cited published clinical imaging research that has demonstrated FAP-targeted tracer uptake in SFTs, along with early human imaging data for PSV359 showing strong tumor uptake and fast renal clearance.¹

Regarding the regulatory pathway, the FDA's Fast Track program is intended to facilitate development and expedite review of therapies for serious conditions with unmet medical needs, and Fast Track-designated products may also qualify for rolling review, Accelerated Approval, or Priority Review if applicable requirements are met, though FDA treats these as distinct expedited programs with separate qualifying criteria.¹

The company is running a multi-center, open-label, dose-finding and dose-expansion study (clinicaltrials.gov identifier NCT06710756) of [212Pb]PSV359 in patients with advanced solid tumors that express FAP-α, with the primary objective of the dose-finding phase being to assess safety and tolerability of various doses to inform selection of the recommended Phase 2 dose.¹ Antitumor activity may be evaluated as an additional primary outcome in the expansion portion of the study.¹

Perspective's broader pipeline includes bamzireotide navoxetan (VMT-α-NET, neuroendocrine tumors), lapemelanotide zapixetar (VMT01, melanoma), and PSV359 (solid tumors).¹