NORTH BILLERICA, Mass.--(BUSINESS WIRE)--Lantheus Holdings, Inc. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to find, fight and follow serious medical conditions, announced today that the U.S. Food and Drug Administration (FDA) has approved PYLARIFY, an F 18-labeled prostate-specific membrane antigen (PSMA) targeted positron emission tomography (PET) imaging agent to identify suspected metastasis or recurrence of prostate cancer. 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.

“The FDA approval of PYLARIFY is a significant milestone for Lantheus and the prostate cancer community in the United States. 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,” said Mary Anne Heino, President and Chief Executive Officer of Lantheus. “I would like to thank the patients who participated in our clinical trials, the study investigators and our employees, whose efforts made this achievement possible.”

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.1 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.2,3
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.4 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.5,6

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