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Lantheus Announces FDA Approval of PYLARIFY TruVu™ (piflufolastat F 18) Injection

LNTH
  • The U.S. FDA has approved PYLARIFY TruVu (piflufolastat F 18) injection, a new formulation of Lantheus' market-leading PSMA PET imaging agent.
  • PYLARIFY TruVu is indicated for PET imaging of PSMA-positive lesions in men with suspected metastasis or suspected recurrence based on elevated PSA levels.
  • The new formulation was approved via the 505(b)(2) pathway using data from the OSPREY & CONDOR pivotal studies, maintaining similar diagnostic properties, safety, & effectiveness as the original PYLARIFY.
  • PYLARIFY TruVu is designed for enhanced stability at higher radioactive concentrations to support larger batch sizes, improved manufacturing efficiency, & broader geographic availability.
  • Commercial availability for PYLARIFY TruVu is expected in the fourth quarter of 2026 with a phased geographic rollout to facilitate a seamless customer transition.
  • Clinical data from the OSPREY trial showed PYLARIFY PET/CT delivered significantly higher specificity (97.9% vs 65.1%) & nearly three times the positive predictive value compared to standard imaging.
  • The CONDOR trial established a correct localization rate of 85%-87% for PYLARIFY in men with biochemical recurrent prostate cancer.
  • Adverse reactions reported in clinical studies included headache, dysgeusia, & fatigue (each at ≤2% of patients), with one delayed hypersensitivity reaction observed.
  • Warnings include risks of image misinterpretation, potential hypersensitivity reactions, & radiation exposure requiring hydration & frequent voiding.
  • Androgen deprivation therapy may alter uptake of the agent, though the effect on performance has not been fully established.
  • Over 760,000 PSMA PET scans have been performed using the original PYLARIFY formulation since its May 2021 FDA approval.