FDA Approves 18F-DCFPyL as First PSMA PET Imaging Agent Available for Prostate Cancer

The approval of 18F-DCFPyL comes on the heels of positive results from the company-sponsored research in the CONDOR and OSPREY trials investigating the imaging agent for prostate cancer.

The FDA approved the F 18-labeled prostate-specific membrane antigen (PSMA)–targeted positron emission tomography (PET) imaging agent 18F-DCFPyL (Pylarify) for use in prostate cancer, according to an announcement from the company responsible for the agent, Lantheus Holdings, Inc.

18F-DCFPyL is now the first commercially available PSMA PET imaging agent for prostate cancer, working to identify suspected metastasis or recurrence in patients with prostate cancer.

“The FDA approval of Pylarify is a significant milestone for Lantheus and the prostate cancer community in the United States. We believe Pylarify represents a paradigm shift in the identification and management of patients with suspected metastasis or recurrent prostate cancer, providing more accurate and earlier detection of disease than conventional imaging so that doctors, along with patients and their families, can make more informed treatment decisions,” Mary Anne Heino, President and Chief Executive Officer of Lantheus, said in a press release.

The approval is based on data from 2 studies, the OSPREY (NCT02981368) and CONDOR (NCT03739684) trials, investigating the safety and diagnostic performance of 18F-DCFPyL in prostate cancer.

In the phase 2/3 OSPREY trial, improvements in the specificity (96%-99%) and positive predictive value (78%-91%) of the agent were observed when compared with conventional imaging for metastatic prostate cancer.

The most common adverse events (AEs) in the trial included dysgeusia (2.6%), headache (1.8%), and fatigue (1.3%), which were observed across all grades of severity.

Eligible patients in the OSPREY trial were divided into 2 cohorts, with cohort A including patients with high-risk, locally advanced prostate cancer, and cohort B including patients with metastatic or recurrent disease.

“Conventional imaging has significant limitations in detecting prostate cancer, both in initial staging and when the cancer has recurred or spread after initial primary treatment. Specifically, standard imaging poorly detects the early spread to distant organs, such as the lymph nodes, bones, and other organs,” Michael J. Morris, MD, prostate cancer section head of Genitourinary Medical Oncology at the Memorial Sloan Kettering Cancer Center, lead investigator on the CONDOR trial, and study investigator on the OSPREY trial, said in a press release.

In the phase 3 CONDOR study, a median PSA level of 0.8 ng/mL was observed among the 208 evaluable patients, with 68.8% having a PSA level of less than 2.0 ng/mL. Of note, 27.9% of patients received at least 1 prior systemic therapy.

The primary end point of correct localization rates (CLRs), identified by PyL–PET/CT and evaluated by 3 blinded independent central readers were observed at 85.6% (95% CI, 78.8%-92.3%), 87.0% (95% CI, 80.4%-93.6%), and 84.8% (95% CI, 77.8%-91.9%).

Patients in the CONDOR study who underwent radical prostatectomy were eligible if they had a PSA level 0.2 or more. Patients treated with radiation therapy or cryotherapy required a PSA level 2.0 or more to be eligible.

“We believe today’s approval is a game-changer for men facing prostate cancer,” Jamie Bearse, Chief Executive Officer of ZERO - The End of Prostate Cancer, a Patient Advocacy Group, said in a press release. “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.”


Lantheus Receives U.S. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for Prostate Cancer. News release. Lantheus Holdings, Inc. Published May 27, 2021. Accessed May 27, 2021. https://bwnews.pr/3p2wCKD