FDA has approved Pylarify, an F 18-labeled prostate-specific membrane antigen targeted positron emission tomography imaging agent to identify suspected metastasis or recurrence of prostate cancer.
Pylarify is sponsored by Lantheus Holdings Inc.
Pylarify is the first and only commercially available approved PSMA PET imaging agent for prostate cancer. The product will be immediately available in parts of the mid-Atlantic and southern regions and availability is expected to rapidly expand over the next six months with broad availability across the U.S. anticipated by year end.
Identification of suspected metastatic disease in men considering initial definitive therapy is important to optimize treatment planning and to avoid futile interventions.
Of men with localized prostate cancer who undergo initial curative intent/management, up to 50% may experience recurrence of their disease within ten years of treatment.
Recurrent disease is often detected by a rise in serum prostate-specific antigen (PSA) levels; however, conventional imaging, especially at low PSA levels, is not able to identify the location and extent of the disease in the majority of cases.
Pylarify was developed to target PSMA, a protein that is overexpressed on the surface of more than 90% of primary and metastatic prostate cancer cells. Pylarify binds to the target, enabling the reader of the PET scan to detect and locate the disease.
Cyclotron production of F 18 offers high batch capacity and high image resolution, and F 18’s 110-minute half-life allows for wide geographic distribution.
The approval of Pylarify is based on data from two Company-sponsored pivotal studies (OSPREY and CONDOR) designed to establish the safety and diagnostic performance of PYLARIFY across the prostate cancer disease continuum.
Results from OSPREY (Cohort A) demonstrated improvement in specificity and positive predictive value (PPV) of Pylarify PET imaging over conventional imaging in men at risk for metastatic prostate cancer prior to initial therapy. CONDOR studied men with biochemical recurrent prostate cancer. In patients with biochemical recurrent prostate cancer and non-informative baseline imaging, Pylarify demonstrated high correct localization and detection rates, including in patients with low PSA values (median PSA 0.8 ng/mL).
In the clinical trials, PYLARIFY was well tolerated. In OSPREY and CONDOR, 593 patients with various states of prostate cancer were exposed to a single dose of PYLARIFY.
