FDA Approves New PYLARIFY TruVu Formulation for Enhanced Prostate Cancer Imaging

Lantheus Holdings, Inc. has secured FDA approval for its latest formulation, PYLARIFY TruVu (piflufolastat F 18) injection. This new version builds on the diagnostic capabilities of the widely used PSMA PET imaging agent, PYLARIFY, which targets prostate-specific membrane antigen (PSMA) in prostate cancer patients.

The updated formulation is designed to offer improved manufacturing efficiency, allowing production of larger batches, thereby increasing availability for patients. PYLARIFY TruVu will be integral for PET imaging of PSMA-positive lesions in men who are either suspected to be metastatic candidates for initial definitive therapy, or those with suspected recurrence based on elevated PSA levels. The product is expected to reach the market in the fourth quarter of 2026, with distribution across various regions to ensure a seamless transition from the existing PYLARIFY formulation.

PYLARIFY TruVu gained FDA approval following a submission via the 505(b)(2) regulatory pathway, enabling reliance on prior data from two key pivotal studies: OSPREY and CONDOR. This submission method allows for a more streamlined approval process by supplementing new formulations with previously established evidence.

The OSPREY study, a phase 2/3 clinical trial, evaluated the diagnostic performance of PSMA-targeted PET with PYLARIFY in detecting pelvic nodal metastases. It involved 385 patients, showing that PSMA-targeted PET scans delivered significantly higher specificity than standard imaging.

Meanwhile, the CONDOR study, a phase 3 clinical trial, assessed the performance of PYLARIFY in patients with suspected recurrent or metastatic prostate cancer yielding negative or ambiguous results in standard imaging. The study demonstrated a correct localization rate of 85%-87% with a PSMA-targeted PET scan, indicating high diagnostic accuracy.

Safety evaluations for PYLARIFY involved 593 patients and reported common adverse reactions such as headaches, dysgeusia, and fatigue in less than 2% of patients. There was also one case of a delayed hypersensitivity reaction.

With prostate cancer cases expected to rise, the new PYLARIFY TruVu formulation represents Lantheus' commitment to advancing diagnostic capabilities in prostate cancer care. This innovation aims to address the increasing demand for precise imaging, ultimately enhancing diagnostic accuracy and patient outcomes.