Lantheus Announces Presentations Featuring PYLARIFY® (Piflufolastat F18), PYLARIFY AI™ and NM-01 (PD-L1 Imaging) at the 2022 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting
Presentation details are as follows:
PYLARIFY® (Piflufolastat F18), PSMA-targeted PET imaging agent for prostate cancer
Date & Time:
Session Title: Urologic Malignancies
Title: The Impact of Concomitant Use of Androgen Deprivation Therapies (ADT) on the Efficacy of Piflufolastat F 18-PET/CT in Patients with Prostate Cancer: a Sub-group Analysis of OSPREY Cohort B
Publication (Program ID): 2625
PYLARIFY AI™, FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans
Date & Time:
Session Title: Oncology Basic/Translational Integrated Session
Title: Prospectively planned and Independent Validation of aPROMISE in a Phase III CONDOR Study for Rapid Lesion Detection and Standardized Quantitative Evaluation for 18F-DCFPyL (PSMA) Imaging in Prostate Cancer*
Publication (Program ID): 2496
*nominated for the Henry N. Wagner, Jr., MD “Image of the Year”
Title: Quantitative Assessment of PSMA PET Response to Androgen Deprivation in Veterans with Treatment Naïve Castration Sensitive Prostate Cancer
Publication (Program ID): 3070
Tc99m-NM-01, novel imaging agent currently under development for the assessment of PD-L1 expression in non-small cell lung cancer
Date & Time:
Session Title: Thoracic Malignancies: Breast and Lung
Title: SPECT/CT using 99mTc-labeled anti-programmed death-ligand 1 (PD-L1) single-domain antibody (NM-01) to predict response to immune checkpoint inhibition in non-small cell lung cancer: preliminary results from the PD-L1 Expression in Cancer (PECan) study
Publication (Program ID): 2594
PYLARIFY® (piflufolastat F 18) Injection
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
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.
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.
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.
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.
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.
For important risk and use information about PYLARIFY Injection, please see Full Prescribing information.
Senior Director, Investor Relations
Senior Director, Corporate Communications
Source: Lantheus Holdings, Inc.