Lantheus Announces Addition of PSMA PET Imaging Agent to the National Comprehensive Cancer Network® (NCCN) Guidelines for Prostate Cancer

Lantheus’ product, PYLARIFY (piflufolastat F18) injection, is the first and only commercially available and FDA-approved PSMA-targeted PET imaging agent for prostate cancer

San Francisco, CA ( -- Lantheus Holdings, Inc. (the “Company”), 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, announced that prostate specific membrane antigen (PSMA) positron emission tomography (PET) imaging with piflufolastat F 18 has been included in recently updated National Comprehensive Cancer Network® (NCCN) Guidelines® for prostate cancer. The NCCN Guidelines® are widely recognized and used as the standard for clinical policy in oncology by clinicians and payors.

Lantheus’ product, PYLARIFY® (piflufolastat F 18) injection, is a radioactive diagnostic agent indicated for PET imaging of PSMA positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy and/or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. PYLARIFY was approved by the U.S. Food and Drug Administration (FDA) in May 2021 and remains the first and only commercially available PSMA-targeted PET imaging agent for prostate cancer.

Prostate cancer is the second most common form of cancer affecting men in the United States and 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.1

“We are extremely pleased that the NCCN panel of prostate cancer experts, who are dedicated to high-quality, high-value, patient-centered cancer care, have added PSMA-targeted PET imaging with piflufolastat F 18 in unfavorable intermediate, high and very high risk as well as recurrent disease to the updated 2021 guidelines, for the management of prostate cancer,” said Bela Denes, MD, Vice President of Medical Affairs of Lantheus. “In addition to FDA approval, inclusion in the guidelines further validates PYLARIFY’s performance and utility and will raise awareness within the medical community and payors of the potential impact of this novel PSMA-targeted imaging agent in the care of men with prostate cancer.”
The NCCN® is a not-for-profit alliance of 31 leading cancer centers devoted to patient care, research, and education. NCCN is dedicated to improving and facilitating quality, effective, efficient, and accessible cancer care so patients can live better lives. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. By defining and advancing high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers around the world. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) provide transparent, evidence-based, expert consensus recommendations for cancer treatment, prevention, and supportive services; they are the recognized standard for clinical direction and policy in cancer management and the most thorough and frequently updated clinical practice guidelines available in any area of medicine.


  1. American Cancer Society. Facts & Figures 2021. American Cancer Society. Atlanta, GA. 2021.

Source: Imaging, Lantheus. 2021. "Lantheus Announces Addition Of PSMA PET Imaging Agent To The National Comprehensive Cancer Network® (NCCN) Guidelines For Prostate Cancer". Globenewswire News Room.
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