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FDA grants Fast Track Designation for Perspective Therapeutics' PSV359 in FAP-positive solitary fibrous tumors
CATXPerspective Therapeutics, Inc.
The U.S. Food and Drug Administration granted Fast Track Designation for the development of [212Pb]PSV359 (PSV359) to treat adult patients with locally advanced unresectable and/or metastatic fibroblast activation protein-positive solitary fibrous tumors. This designation facilitates more frequent interactions with regulators and may allow for rolling review, Accelerated Approval, or Priority Review if applicable requirements are met. PSV359 is an investigational FAP-targeted alpha-particle therapy currently being evaluated in a Phase 1/2a study. Perspective Therapeutics operates as a radiopharmaceutical development company pioneering advanced treatments for cancers throughout the body.