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# FDA Approves Progenics’ Pylarify for Prostate Cancer Imaging
- URL: https://www.fdaweb.com/fda-approves-progenics-pylarify-for-prostate-cancer-imaging/
- Published: 2021-05-27T12:00:00.000Z
- Updated: 2026-09-14T17:00:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149422

FDA has approved Progenics Pharmaceuticals’ Pylarify (piflufolastat F 18), a drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PMSA) positive lesions in men with prostate cancer. An agency [notice](https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-second-psma-targeted-pet-imaging-drug-men-prostate-cancer?utm%5Fmedium=email&utm%5Fsource=govdelivery) says the approval gives certain men with prostate cancer greater access to PMSA-targeted PET imaging that can help healthcare providers assess prostate cancer.

Pylarify is indicated for patients with suspected prostate cancer metastasis who are potentially curable by surgery or other therapy, FDA says. It also is indicated for patients with suspected prostate cancer recurrence based on elevated serum prostate-specific antigen levels.

Pylarify’s safety and efficacy were evaluated in two clinical trials of 593 men with prostate cancer who each received one injection of the drug. The most common adverse reactions were headaches, altered taste, and fatigue. FDA says there is a risk of hypersensitivity reactions to Pylarify, particularly in patients with a history of allergy to other drugs and foods. There is a risk for misdiagnosis because Pylarify binding may occur in other types of cancer as well as certain non-malignant conditions that may lead to image interpretation errors. And there are radiation risks because Pylarify contributes to a patient’s overall long-term cumulative radiation exposure.

FDA granted Pylarify priority review for this indication.