On June 11, 2025 Lantheus Holdings, Inc. (the Company) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, reported the presentation of new data highlighting two oncology radiodiagnostic agents will be presented at the upcoming 2025 Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting, taking place June 21-24, 2025, in New Orleans, LA.

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Presentation details are as follows:

Oral Presentations

Date & Time: Tuesday, June 24, 2025; 2:30 – 3:35 PM CT
Session Number: SS39
Session Title: Advancing Radiopharmaceutical Production, Quality Control, and Translational Readiness
Title: Optimized Production and Quality Control of the FAP imaging Agent [64Cu]LNTH-1363S
Presenter: Gengyang Yuan, Lantheus

Poster Presentations

Date & Time: Sunday, June 22, 2025; 5:30 – 6:15 PM CT
Session Number: MTA03
Session Title: Oncology: Clinical Diagnosis & Therapy Meet the Author Session, part 1
Title: 18F-Piflufolastat PET/CT in Patients with Biochemically Recurrent Prostate Cancer: a CONDOR Sub-analysis of Positive Predictive Value in the Prostate/Prostatic Bed Stratified by PSA
Presenter: Amir Iravani, University of Washington

Date & Time: Monday, June 23, 2025; 10:30 – 11:15 AM CT
Session Number: MTA06
Session Title: Oncology: Discovery & Translational Meet the Author Session
Title: First Clinical Evaluation of 68Ga-LNTH-1363S, a Novel FAP-Targeting Radiopharmaceutical for PET Imaging: Physiological Biodistribution and Tumor Uptake in Cancer Patients
Presenter: Ida Sonni, University of California, Los Angeles

Date & Time: Tuesday, June 24, 2025; 8:00 – 9:15 AM CT
Session Number: SS27
Session Title: Emerging Role of Fibroblast Activation in Cardiovascular Imaging
Title: Preclinical assessment of 64Cu-LNTH-1363S for FAP PET imaging in mouse models of myocardial infarction
Presenter: Gyu Seong Heo, Department of Radiology, Washington University

About PYLARIFY (piflufolastat F 18) Injection
PYLARIFY (piflufolastat F 18) injection (also known as 18F-DCFPyL or PyL) is a fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. For men with prostate cancer, PYLARIFY PET combines the accuracy of PET imaging, the precision of PSMA targeting and the clarity of an F 18 radioisotope for superior diagnostic performance. The recommended PYLARIFY dose is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection.1-6

PYLARIFY has made a profound impact on the lives of patients battling prostate cancer. It is the number one ordered PSMA PET imaging agent in the U.S., and is a proven diagnostic backed by real-world experience, including in over 500,000 scans across 48 states.

PYLARIFY (piflufolastat F 18) Injection

Indication

PYLARIFY (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

with suspected metastasis who are candidates for initial definitive therapy.
with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
Important Safety Information

Contraindications

None.

Warnings and Precautions

Risk of Image Misinterpretation
Imaging interpretation errors can occur with PYLARIFY imaging. A negative image does not rule out the presence of prostate cancer, and a positive image does not confirm the presence of prostate cancer. The performance of PYLARIFY for imaging of patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. The performance of PYLARIFY for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by risk factors such as Gleason score and tumor stage. PYLARIFY uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes and in normal tissues. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Hypersensitivity Reactions
Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods. Reactions may be delayed. Always have trained staff and resuscitation equipment available.

Radiation Risks
Diagnostic radiopharmaceuticals, including PYLARIFY, expose patients to radiation. Radiation exposure is associated with a dose-dependent increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.

Adverse Reactions
The most frequently reported adverse reactions were headaches, dysgeusia and fatigue, occurring at rate of ≤2% during clinical studies with PYLARIFY. In addition, a delayed hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reactions.

Drug interactions

Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of PYLARIFY in prostate cancer. The effect of these therapies on performance of PYLARIFY PET has not been established.

To report suspected adverse reactions for PYLARIFY, call 1-800-362-2668 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please read the accompanying full Prescribing Information also available at PYLARIFY.com.

(Press release, Lantheus, JUN 11, 2025, View Source [SID1234662960])