Lantheus' Pylarify (piflufolastat F 18) Injection Receives the US FDA's Approval for the Treatment of Prostate Cancer
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: 1st study showed improvement in specificity & PPV compared with conventional imaging for metastatic prostate cancer & 2nd 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 1st 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
| Ref: Business Wire | Image: PR Newswire
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