212Pb-VMT01

October 8, 2026: Perspective Therapeutics (NYSE: CATX) said the FDA granted Fast Track Designation to PSV359 for adult patients with locally advanced unresectable and/or metastatic FAP-positive solitary fibrous tumors (SFTs), a rare cancer with limited treatment options.

[212Pb]PSV359 is an investigational FAP-targeted alpha-particle therapy currently in an ongoing Phase 1/2a study in advanced FAP-positive solid tumors. The company said published clinical imaging research has shown FAP-targeted tracer uptake in SFTs, supporting the rationale in this indication, and that early human imaging data for PSV359 showed strong tumor uptake and fast renal clearance.

The release notes that Fast Track may allow more frequent FDA interactions and potential eligibility for rolling review, Accelerated Approval, or Priority Review if criteria are met.

Perspective also said it is running a multi-center, open-label dose-finding and dose-expansion trial of [212Pb]PSV359 in advanced solid tumors expressing FAP-α, identified by imaging with [203Pb]PSV359 (NCT06710756). The dose-finding phase is assessing safety and tolerability to select a recommended Phase 2 dose, with antitumor activity potentially evaluated as an additional primary outcome in the expansion portion.