Lantheus Holdings, Inc. (NASDAQ: LNTH) announced upcoming presentations featuring their flagship diagnostic agent PYLARIFY® (piflufolastat F 18) at the 2025 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium in San Francisco, scheduled for February 13-15, 2025.
Key Clinical Findings and Real-World Evidence
Two significant poster presentations will highlight PYLARIFY's clinical utility. Dr. Ida Sonni from the University of California's Department of Radiation Oncology will present findings on PYLARIFY's capability to detect recurrent prostate cancer in patients with minimal PSA levels. This research could potentially impact early intervention strategies for prostate cancer recurrence.
In a separate presentation, Dr. Neal Shore from the Carolina Urologic Research Center will share preliminary observations from the PYLARIFY Registry, examining the diagnostic agent's role in both newly-diagnosed and recurrent prostate cancer cases compared to conventional imaging methods.
Clinical Impact and Market Leadership
PYLARIFY has established itself as the most frequently ordered PSMA PET imaging agent in the United States, with more than 400,000 scans performed across 48 states. The diagnostic tool combines PET imaging accuracy with PSMA targeting specificity, utilizing an F 18 radioisotope for enhanced diagnostic performance.
The recommended administration protocol involves a 333 MBq (9 mCi) dose, delivered through bolus intravenous injection, with an acceptable range of 296-370 MBq (8-10 mCi).
Diagnostic Applications and Patient Selection
PYLARIFY serves two critical diagnostic needs in prostate cancer management:
- Detecting suspected metastasis in patients considering initial definitive therapy
- Identifying suspected recurrence in patients with elevated PSA levels
The imaging agent's performance varies based on several clinical factors, including serum PSA levels for recurrence detection and risk factors such as Gleason score and tumor stage for metastatic pelvic lymph node imaging.
Safety Profile and Clinical Considerations
Clinical studies have shown a favorable safety profile, with minimal adverse reactions reported. The most common side effects include headaches, dysgeusia, and fatigue, occurring in ≤2% of patients. Healthcare providers should note that androgen deprivation therapy and other androgen pathway-targeted treatments may influence PYLARIFY uptake, though the exact impact on PET performance remains under investigation.
As a radiopharmaceutical, PYLARIFY requires proper handling protocols to protect both patients and healthcare workers from unintentional radiation exposure. Patients are advised to maintain proper hydration before and after administration.
