On June 14, 2021 Lantheus Holdings, Inc. (the "Company") (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to find, fight and follow serious medical conditions, reported that data from the piflufolastat F 18 (formerly known as 18F-DCFPyL) CONDOR pivotal trial will be presented at the Virtual Society of Nuclear Medicine and Molecular Imaging (SNMMI) annual meeting (Press release, Lantheus Medical Imaging, JUN 14, 2021, View Source [SID1234583971]).

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Dr. Steven Rowe, Associate Professor of Radiology and Radiological Science at Johns Hopkins University, will deliver an oral presentation entitled: "A Phase 3 study of 18F-DCFPyL-PET/CT in Patients with Biochemically Recurrent Prostate Cancer (CONDOR): An Analysis of Disease Detection Rate and Positive Predictive Value (PPV) by Anatomic Region" on Tuesday, June 15, 2021. The presentation was also selected to be included in the Henry N. Wagner, Jr., MD Highlights Symposium plenary session.

In the CONDOR trial, piflufolastat F 18 detected and localized metastatic lesions with high positive predictive value (PPV) regardless of anatomic region in men with biochemically recurrent prostate cancer where standard imaging was uninformative. The median detection rates for prostate/prostate bed, lymph nodes and extra-pelvic region were: 20.2% (CI: 14.7-25.6%), 35.1% (CI: 28.6-41.6%) and 26.4% (CI: 20.4-32.4%), respectively. The median PPV (≥1 lesion confirmed) by anatomic region was: 79.5% (CI: 66.8-92.2%) for the prostate/prostate bed, 70.9% (CI: 58.9-82.9%) for pelvic lymph nodes and 67.4% (CI: 53.8-80.9%) for the extra-pelvic region.

Oral Presentation Details are as follows:
Title: A Phase 3 study of 18F-DCFPyL-PET/CT in Patients with Biochemically Recurrent Prostate Cancer (CONDOR): An Analysis of Disease Detection Rate and Positive Predictive Value (PPV) by Anatomic Region
Lead Author: Steven Rowe, Johns Hopkins University
Session Date and Time: June 15, 2021 2:00 – 3:00 PM ET
Session Title: Advances in PET Imaging for Cancer: Highlights of Clinical Diagnostics in Oncology

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 radioisotope5 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

About Prostate Cancer

Prostate cancer is the second most common form of cancer affecting men in the United States — an estimated one in eight men will be diagnosed with prostate cancer in their lifetimes. The American Cancer Society estimates that in 2021, almost 250,000 new cases of prostate cancer will be diagnosed, and more than 30,000 men will die of the disease. Approximately 3.1 million men in the United States currently count themselves as prostate cancer survivors.7

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.