FDA Approves First PET Imaging Agent to Identify Prostate Cancer Metastasis or Recurrence

Lantheus announced that the Food and Drug Administration (FDA) approved Pylarify, a positron emission tomography (PET) imaging agent to identify patients with suspected metastasis or recurrence of prostate cancer.

This F 18-labeled prostate-specific membrane antigen (PSMA) targeted PET imaging agent is the first and only commercially available agent to be approved by the FDA for prostate cancer, according to a press release from the company.

“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 chief executive officer of Lantheus, said in the 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.”

In particular, Pylarify targets PSMA, a protein often overexpressed in more than 90% of primary and metastatic prostate cancer cells, according to the release. The agent binds to PSMA, which allows the PET scan to detect and locate possible disease.

Identifying suspected metastatic disease in men who may be considering definitive therapy at first is important to avoid unnecessary interventions and to optimize treatment planning. Up to 50% of men with localized prostate cancer who underwent curative intent/management at first may have cancer recurrence within 10 years after completing treatment, according to the release. Cancer recurrence can often be detected by an increase in prostate-specific antigen (PSA) levels in the blood, although conventional imaging techniques cannot identify the location and extent of disease especially in patients with low PSA levels.

“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,” Dr. Michael J. Morris, prostate cancer section head at Memorial Sloan Kettering Cancer Center, 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.”

Pylarify will be available in southern and mid-Atlantic regions of the U.S. immediately with plans to rapidly expand over the next six months, according to the release.

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