[²¹²Pb]PSV359 receives FDA Fast Track Designation for FAP-positive solitary fibrous tumors

CAR-T Digest - August 2020

Weekly Digest - October 2026

08 October 2026: [²¹²Pb]PSV359 receives FDA Fast Track Designation for FAP-positive solitary fibrous tumors

Perspective Therapeutics has received U.S. FDA Fast Track Designation for [²¹²Pb]PSV359 for adults with locally advanced unresectable and/or metastatic fibroblast activation protein-positive solitary fibrous tumors, a rare cancer with limited treatment options
The designation supports accelerated development of PSV359, which is being evaluated in an ongoing Phase 1/2 study in patients with advanced FAP-positive solid tumors. Published imaging research has demonstrated FAP-targeted tracer uptake in SFTs, while early human imaging data for PSV359 indicate strong tumor uptake and rapid renal clearance
The designation addresses an unmet need in advanced SFT, where patients with unresectable or metastatic disease have limited treatment options and no approved therapies specifically targeting FAP-α
PSV359 is an investigational FAP-targeted alpha-particle radiopharmaceutical therapy that delivers lead-212 (²¹²Pb) to FAP-expressing tumor sites. Its targeting ligand can also be labeled with lead-203 or gallium-68 for imaging, enabling a theranostic approach to identify FAP-positive tumors and guide treatment
Strategically, the designation strengthens Perspective’s FAP-targeted radiopharmaceutical development strategy and provides an opportunity to advance PSV359 in SFT while exploring its broader potential across FAP-positive solid tumors. Fast Track may facilitate closer FDA engagement and, if separate eligibility criteria are met, allow access to additional expedited review pathways