FDA Approves Second PSMA-targeted PET Imaging Drug for Men with Prostate Cancer - Drug Information Update

If your email program has trouble displaying this email, view it as a web page. FDA Approves Second PSMA-targeted PET Imaging Drug for Men with Prostate Cancer FDA has approved Pylarify (piflufolastat F 18) – a drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer. With the approval of Pylarify, certain men with prostate cancer will have greater access to PSMA-targeted PET imaging that can aid health care providers in assessing prostate cancer. Pylarify is indicated for patients with suspected prostate cancer metastasis (when cancer cells spread from the place where they first formed to another part of the body) who are potentially curable by surgery or other therapy. Pylarify is also indicated for patients with suspected prostate cancer recurrence based on elevated serum prostate-specific antigen (PSA) levels. Pylarify is a radioactive diagnostic agent that is administered in the form of an intravenous injection. The most common adverse reactions to Pylarify were headache, altered taste, and fatigue. 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 which may lead to image interpretation errors. There are radiation risks because Pylarify contributes to a patient's overall long-term cumulative radiation exposure, which is associated with an increased risk for cancer. Learn More This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO- FDA (1-888-463-6332) or 301-796-3400 from 8:00 am - 4:30 pm ET Monday - Friday. You can also email us at: druginfo@fda.hhs.gov. Stay Connected with U.S. Food and Drug Administration:         SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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