- New formulation of its widely-used U.S. market-leading PSMA PET imaging agent combines the diagnostic performance of PYLARIFY® (piflufolastat F 18) with the potential for larger batches and greater patient availability
- PYLARIFY TruVu™ is expected to launch in 4Q 2026, with a phased geographic rollout to support a seamless customer transition
“The FDA approval of PYLARIFY TruVu demonstrates Lantheus’ continued commitment to advancing innovation that directly expands patient access to high-quality diagnostic tools,” said Mary Anne Heino, Executive Chairperson and CEO, Lantheus. “The availability of PYLARIFY TruVu addresses a key need identified by clinicians – greater access to our market-leading formulation.”
PYLARIFY TruVu was submitted for FDA approval via the 505(b)(2) regulatory pathway, allowing for review based upon previously submitted data from two PYLARIFY pivotal studies: OSPREY and CONDOR. The new formulation has the same diagnostic properties and is expected to offer similar safety and effectiveness as PYLARIFY.
Additionally, PYLARIFY TruVu is designed to enhance product stability at higher radioactive concentrations, supporting more efficient manufacturing and distribution. These improvements are expected to increase batch sizes, enabling manufacturing sites with high‑energy cyclotrons to reach more patients and serve broader geographic markets. Overall, PYLARIFY TruVu has the potential to enhance supply flexibility and improve operating leverage for the network of PMFs that will manufacture and distribute the product.
“As we continue to innovate and expand our portfolio, ensuring a reliable and uninterrupted supply for our customers remains our top priority,” said Dorothy Barr, Senior Vice President, Manufacturing and Technical Operations. “The PYLARIFY TruVu formulation is designed to enhance manufacturing efficiency, strengthen supply chain dependability and ultimately improve the healthcare system’s ability to deliver timely, accurate imaging for people with prostate cancer.”
PYLARIFY TruVu is expected to be commercially available in the fourth quarter of 2026 and will be introduced on a rolling geographic basis, allowing customers to transition from PYLARIFY to the new formulation with minimal disruption.
“As a community dedicated to improving the lives of people facing prostate cancer, we’ve seen firsthand how advanced PSMA PET diagnostic tools like PYLARIFY have truly been game changers, providing real-time, highly accurate information that can meaningfully shape treatment decisions,” said Gina B. Carithers, President and CEO, Prostate Cancer Foundation. “With prostate cancer incidence expected to rise in the years ahead, it’s encouraging to see companies like Lantheus putting patients first and introducing innovations that help ensure timely, precise imaging while keeping pace with growing demand. Access to accurate diagnostics, especially when metastatic or recurrent disease is suspected, can profoundly impact both quality of life and long-term outcomes for people living with prostate cancer.”More than 760,000 people with prostate cancer have received PSMA PET scans with PYLARIFY since the FDA granted approval in May 2021 based on findings from the OSPREY and CONDOR studies.
PYLARIFY® Pivotal Data Summary
The safety and efficacy of PYLARIFY® and PYLARIFY TruVu™ were established based on the PYLARIFY pivotal trials, OSPREY and CONDOR. OSPREY was a phase 2/3 clinical trial of 385 patients. In Cohort A, 252 men with high-risk prostate cancer had evaluable histopathology for determining the diagnostic performance of PYLARIFY in identifying pelvic nodal metastases. OSPREY Cohort A assessed sensitivity, specificity, PPV, and NPV in pelvic lymph nodes and the prostate gland for PSMA-targeted PET with PYLARIFY. The median sensitivity, specificity, PPV and NPV were 38% (26, 51), 96% (94, 99), 77% (62, 92) and 83% (78, 88). Results showed that a PSMA-targeted PET scan with PYLARIFY significantly improved specificity over standard imaging while maintaining comparable sensitivity and delivering high PPV and NPV in men at risk for metastatic prostate cancer prior to initial therapy. Compared to standard imaging, PYLARIFY PET/CT delivered: Significantly higher specificity (97.9% vs 65.1%), nearly three times the PPV (86.7% vs 28.3%) and similar sensitivity to standard imaging (40.3% vs 42.6%).1
CONDOR was a robust, multicenter, phase 3 trial of 208 patients with suspected recurrent or metastatic prostate cancer with negative or equivocal results using standard imaging. The study design assessed correct localization rate (CLR), a metric of diagnostic performance measuring PPV at the patient level enhanced with anatomic lesion matching in patients with biochemically recurrent (BCR) prostate cancer.
CONDOR found that a PSMA-targeted PET scan with PYLARIFY in men with biochemical recurrent prostate cancer achieved the primary endpoint of correct localization rate (CLR): 85%-87% across all 3 readers (lower bound of 95% CI: 78%-80%).2
The safety of PYLARIFY was evaluated in 593 clinical patients who were exposed to a single dose of PYLARIFY and was generally well tolerated. The most common adverse reactions reported in ≤ 2% of patients were headache, dysgeusia and fatigue. In addition, a delayed hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reaction.3
Source: Lantheus Holdings, Inc. (2026). Lantheus Announces FDA Approval of PYLARIFY TruVu™ (piflufolastat F 18) Injection [Press release]. https://lantheusholdings.gcs-web.com/news-releases/news-release-details/lantheus-announces-fda-approval-pylarify-truvutm-piflufolastat-f.