BEDFORD, Mass., June 11, 2025 (GLOBE NEWSWIRE) — 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, announced 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.
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 http://www.fda.gov/medwatch.
Please read the accompanying full Prescribing Information also available at PYLARIFY.com.
About Lantheus
Lantheus is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada, Switzerland and Sweden, Lantheus has been providing radiopharmaceutical solutions for nearly 70 years. For more information, visit http://www.lantheus.com.
1PYLARIFY® [package insert]. North Billerica, MA: Progenics Pharmaceuticals, Inc., a Lantheus company.
2Data on file. Bedford, MA: Progenics Pharmaceuticals, Inc.; 2024.
3Mena E, Lindenberg ML, Turkbey IB, et al. 18F-DCFPyL PET/CT imaging in patients with biochemically recurrent prostate cancer after primary local therapy. J Nucl Med. 2020;61(6):881-889.
4Werner RA, Derlin T, Lapa C, et al. 18F-labeled, PSMA-targeted radiotracers: leveraging the advantages of radiofluorination for prostate cancer molecular imaging. Theranostics. 2020;10(1):1-16.
5Alipour R, Azad A, Hofman MS. Guiding management of therapy in prostate cancer: time to switch from conventional imaging to PSMA PET? Ther Adv Med Oncol. 2019;11:1-14.
6Petersen LJ, Zacho HD. PSMA PET for primary lymph node staging of intermediate and high-risk prostate cancer: an expedited systematic review. Cancer Imaging. 2020;20(1):10.
Contacts:
Lantheus
Mark Kinarney
Vice President, Investor Relations
978-671-8842
ir@lantheus.com
Melissa Downs
Executive Director, External Communications
646-975-2533
media@lantheus.com
