Shots:

• The approval is based on data from 2 pivotal studies i.e OSPREY & CONDOR evaluating the safety & diagnostic performance of Pylarify in patients with prostate cancer
• Results: 1^st study showed improvement in specificity & PPV compared with conventional imaging for metastatic prostate cancer & 2^nd study showed high CLRs & detection rates includes low PSA values (median PSA is 0.8 ng/mL) for biochemically recurrent prostate cancer & non-informative baseline imaging
• Pylarify is the 1^st commercially available approved PSMA PET imaging agent for prostate cancer & will be available immediately in mid-Atlantic & southern regions- expected to be broadly available in the US at the end of 2021

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