The U.S. Food and Drug Administration (FDA) approved a new imaging agent for detection of prostate cancer, providing a more effective imaging approach to detect the spread of cancer to other parts of the body. Piflufolastat F-18 injection is the first fluorinated prostate-specific membrane antigen (PSMA) agent approved by the FDA and also the first commercially available PSMA PET imaging agent.

Image courtesy of JNM


June 28, 2021 — The U.S. Food and Drug Administration (FDA) approved a new imaging agent for detection of prostate cancer, providing a more effective imaging approach to detect the spread of cancer to other parts of the body. Piflufolastat F-18 injection is the first fluorinated prostate-specific membrane antigen (PSMA) agent approved by the FDA and also the first commercially available PSMA PET imaging agent.

The agent is approved for PET imaging of PSMA-positive lesions in men with prostate cancer

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

“We believe today’s approval is a game-changer for men facing prostate cancer,” said Jamie Bearse, Chief Executive Officer of ZERO – The End of Prostate Cancer, a patient advocacy group. “Having a diagnostic tool that allows doctors to see suspected metastatic or recurrent prostate cancer earlier, anywhere in the body, is a significant step forward and will have a tremendous impact on patients’ lives.”

The agent, initially called 18F-DCFPyL, was developed by Martin Pomper, MD, PhD, director of nuclear medicine and molecular imaging at the Johns Hopkins University School of Medicine. The New Drug Application for the agent was filed in September 2020 and granted priority review by the FDA in December. Research supporting the approval of the agent came from two pivotal multicenter studies—the CONDOR study and the OSPREY study.

The agent is manufactured by Lantheus as Pylarify injection and will be widely available throughout the United States.

For more information: www.snmmi.org

Related Prostate Imaging Agent Information:

PSMA-Targeted Radiotracer Pinpoints Metastatic Prostate Cancer Across Anatomic Regions

For Additional SNMMI21 Content:

SNMMI Channel

PSMA PET/CT Can Change Management in Recurrent Prostate Cancer

PSMA PET/CT Can Change Management in Recurrent Prostate Cancer

Total-body Dynamic PET Successfully Detects Metastatic Cancer

New PET Radiotracer Proven Safe in Imaging Malignant Brain Tumors

Targeted Radionuclide Therapy Enhances Prostate Cancer Response to Immunotherapies

New PET/MRI Approach Pinpoints Chronic Pain Location, Alters Management


Related Content

News | Radiopharmaceuticals and Tracers

May 30, 2023 — Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization ...

Time May 30, 2023
arrow
News | Radiation Therapy

May 30, 2023 — The first treatment, for a patient with prostate cancer, was successfully carried out on April 28. Yonsei ...

Time May 30, 2023
arrow
News | Breast Imaging

May 25, 2023 — GE HealthCare, a leader in breast cancer care technology and diagnostics, has today announced that NCCN ...

Time May 25, 2023
arrow
News | Oncology Information Management Systems (OIMS)

May 24, 2023 — RaySearch Laboratories AB announced that the oncology information system RayCare* (* subject to ...

Time May 24, 2023
arrow
News | ASTRO

May 23, 2023 — More than 9 in 10 radiation oncologists report that their practices face clinical staff shortages ...

Time May 23, 2023
arrow
News | Radiation Oncology

May 23, 2023 — ZAP Surgical Systems, Inc., a leading innovator in the field of surgical robotics, today announced that ...

Time May 23, 2023
arrow
News | Radiation Oncology

May 22, 2023 — Physicians and scientists from the UCLA Jonsson Comprehensive Cancer Center will discuss the latest ...

Time May 22, 2023
arrow
News | PET Imaging

May 22, 2023 — New research finds that the brains of otherwise healthy military personnel who are exposed to explosions ...

Time May 22, 2023
arrow
News | Radiation Oncology

May 18, 2023 — Cassling announced it is a new strategic sales agent in various geographic territories across the United ...

Time May 18, 2023
arrow
News | Digital Pathology

May 18, 2023 — Paige, a global provider of end-to-end digital pathology solutions and clinical Artificial Intelligence ...

Time May 18, 2023
arrow
Subscribe Now