Lantheus has secured U.S. Food and Drug Administration (FDA) approval for Pylarify TruVu (piflufolastat F-18) injection, a new formulation of its existing F-18 prostate-specific membrane antigen (PSMA)-PET imaging agent for men with prostate cancer with suspected metastasis or recurrence.
The new formulation shares the same diagnostic properties as the original Pylarify and is designed to support higher radioactive concentrations, enabling larger batch sizes and broader geographic distribution, according to the company. The FDA cleared it based on data from the OSPREY and CONDOR studies.
Lantheus expects to launch Pylarify TruVu in the fourth quarter of 2026, Lantheus said.
