Dr Wei on the FDA Approval of Pylarify TruVu for PSMA-PET Imaging in Prostate Cancer

“It's good that [Pylarify TruVu] is going to be one of the [available] imaging agents, particularly because there may be a shortage of [gallium Ga 68 PSMA-11].”

Xiao Wei, MD, MAS, the deputy director of clinical research at the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute as well as an assistant professor of Medicine, Harvard Medical School, discussed the clinical significance of the FDA approval of Pylarify TruVu (piflufolastat F 18) injection in prostate cancer.

In March 2026, the FDA approved Pylarify TruVu for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA)–positive lesions in men with prostate cancer with suspected metastasis who can receive initial definitive therapy or suspected recurrence based on elevated serum prostate-specific antigen level. The new formulation has the same diagnostic properties and is expected to offer comparable safety and efficacy to that of piflufolastat F 18 (Pylarify), which was approved by the FDA in May 2021 to identify suspected metastasis or recurrence of prostate cancer.

The March 2026 regulatory decision was supported by data from the phase 2/3 OSPREY (NCT02981368) and phase 3 CONDOR (NCT03739684) trials. Notably, the application for Pylarify TruVu was filed via the 505(b)(2) regulatory pathway, which allowed for the review to be based on these previously completed trials.

Wei noted that although piflufolastat F 18 is already being used in the clinic, the approval of the Pylarify TruVu formulation of the agent will allow for greater access to the imaging modality. Moreover, she added that it will be especially useful in the event of a shortage of gallium Ga 68 PSMA-11 (Illuccix), which was the first PET imaging agent to earn FDA approval for the imaging of PSMA–positive lesions in patients with prostate cancer in December 2020. Increased accessed to piflufolastat F 18 via the Pylarify TruVu formulation will allow oncologists to identify patients for treatments such as lutetium Lu 177 vipivotide tetraxetan (Pluvicto), Wei concluded.