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May 28, 2021Pylarify Approved for PET Imaging of Prostate Cancer
May 27, 2021 – The U.S. FDA has approved Pylarify® (piflufolastat F 18), manufactured by Progenics Pharmaceuticals, for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions. Pylarify is for use in men who have prostate cancer with suspected metastasis who are candidates for initial definitive therapy, or with suspected recurrence based on elevated serum prostate- specific antigen (PSA) levels.
According to the American Cancer Society, prostate cancer will be the most commonly diagnosed cancer in men in 2021. It is the third most common form of cancer in the United States. While computed tomography (CT), magnetic resonance imaging (MRI), and some nuclear medicine scans are commonly used for imaging of prostate cancer, they are limited in the detection of prostate cancer lesions. Only one other PSMA-targeted PET imaging drug holds FDA approval, and the drug is only available locally at two sites in California. Pylarify is expected to be distributed from multiple sites throughout the United States.
The safety and efficacy of Pylarify was confirmed in two clinical trials where use of Pylarify for PET imaging provided valuable information that clinicians could use to make judgments regarding appropriate patient care. Recommended dosing is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection one hour prior to imaging.
Pylarify is a radioactive drug and should be received, used, and administered by authorized persons qualified by appropriate training and experience. It must be handled with appropriate safety measures to minimize radiation exposure during administration.
Launch and pricing information are not yet available.