FDA approves Lantheus’ PYLARIFY TruVu, a new PSMA PET imaging formulation for detecting metastatic or recurrent prostate cancer lesions in men.
Written By: Samiksha Jadhav BPharm
Reviewed By: Pharmacally Editorial Team
The U.S. Food and Drug Administration has approved PYLARIFY TruVu (piflufolastat F 18) injection, a new formulation of Lantheus Holdings’ PSMA-targeted PET imaging agent used to detect prostate cancer lesions. The diagnostic radiopharmaceutical is indicated for PET imaging of prostate-specific membrane antigen (PSMA)–positive lesions in men with prostate cancer who have suspected metastasis or suspected recurrence based on elevated prostate-specific antigen (PSA) levels.
The new formulation builds on the company’s previously approved imaging agent PYLARIFY, which has been widely used in the United States since its approval in 2021. According to Lantheus, more than 760,000 PSMA PET scans have been performed using PYLARIFY.
PYLARIFY TruVu was reviewed through the 505(b)(2) regulatory pathway, relying on previously submitted clinical data from the pivotal OSPREY and CONDOR studies that supported the original PYLARIFY approval. The new formulation is expected to provide similar diagnostic performance and safety as the existing product.
The updated formulation was designed to improve product stability at higher radioactive concentrations, which may help increase manufacturing efficiency and expand distribution capacity. This could enable production facilities to supply imaging centers across broader geographic regions and support growing demand for PSMA PET scans.
Lantheus expects PYLARIFY TruVu to become commercially available in the fourth quarter of 2026, with a gradual rollout across different regions.
Reference
Lantheus Announces FDA Approval of PYLARIFY TruVu™ (piflufolastat F 18) Injection, 06 March 2026, https://investor.lantheus.com/news-releases/news-release-details/lantheus-announces-fda-approval-pylarify-truvutm-piflufolastat-f
About Writer
Samiksha Vikram Jadhav, B.Pharm
She is a pharmacy graduate with a keen interest in clinical research, pharmacovigilance, and medical writing, with a growing focus on publication and scientific content development. In her words, she is passionate about translating complex medical data into clear, evidence-based communication.