FDA approves Pylarify, PET imaging agent for prostate cancer
The FDA approved piflufolastat F 18 injection, a radioactive diagnostic agent designed to identify suspected metastasis or recurrence of prostate cancer, according to the agent’s manufacturer.
Piflufolastat F 18 injection (Pylarify, Lantheus Holdings) is an F18-labeled prostate-specific membrane antigen (PSMA)-targeted PET imaging agent.
“The FDA approval of Pylarify is a significant milestone for Lantheus and the prostate cancer community in the United States,” Mary Anne Heino, president and CEO of Lantheus, said in a company-issued press release. “We believe Pylarify represents a paradigm shift in the identification and management of patients with suspected metastasis or recurrent prostate cancer, providing more accurate and earlier detection of disease than conventional imaging so that doctors — along with patients and their families — can make more informed treatment decisions.”
As many as half of men with localized prostate cancer who undergo initial therapy with curative intent experience disease recurrence within 10 years. Recurrence often is detected by increased serum PSA levels. However, in many cases, conventional imaging is unable to identify the extent and location of the disease.
Pylarify is designed to target PSMA, a protein overexpressed on the surface of more than 90% of primary and metastatic prostate cancer cells. Pylarify binds to the target, helping the PET scan reader detect and locate the disease.
The FDA based the approval on results of two company-sponsored studies — the OSPREY and CONDOR trials — designed to establish the safety and diagnostic performance of Pylarify in prostate cancer.
Results of a cohort in the OSPREY trial showed improved specificity and positive predictive value with Pylarify PET imaging compared with conventional imaging among men at risk for metastatic prostate cancer before initial therapy.
Results of the CONDOR trial showed high correct localization and detection rates with Pylarify among men with biochemical recurrent prostate cancer and noninformative baseline imaging.
Pylarify appeared well-tolerated in both trials; rates of headache, dysgeusia and fatigue were 2% or less.
“Conventional imaging has significant limitations in detecting prostate cancer, both in initial staging and when the cancer has recurred or spread after initial primary treatment,” Michael J. Morris, MD, prostate cancer section head at Memorial Sloan Kettering Cancer Center and an investigator on the CONDOR and OSPREY trials, said in the release. “Specifically, standard imaging poorly detects the early spread to distant organs, such as the lymph nodes, bones and other organs. Pylarify can detect the spread of disease well before standard imaging and can be a transformative diagnostic tool that helps clinicians develop treatment plans based on a much more accurate understanding of a patient’s distribution of disease.”
Perspective
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This approval marks a major milestone in prostate cancer care, improving access to this diagnostic tool that was until now only available abroad and at a handful of U.S. centers. This approval is poised to disrupt care paradigms at all points of the prostate cancer journey. Initial staging of men with prostate cancer will be more accurate, enabling clinicians to better calibrate care intensity. For instance, men with high-risk disease now will have better information regarding cancer stage prior to committing to a treatment path. If a man’s prostate cancer were to progress, patients and physicians now will have much higher-fidelity information regarding where a cancer may be hiding and, thus, potentially helping to develop improved treatment strategies for this common disease.