Lantheus Seeks FDA Approval of PyL Prostate Cancer Imaging Agent

Lantheus Seeks FDA Approval of PyL Prostate Cancer Imaging Agent
Lantheus Holdings has submitted an application to the U.S. Food and Drug Administration (FDA) seeking approval of PyL, an investigational imaging agent used to locate prostate cancer lesions. The new drug application (NDA) sent to the FDA includes a request for priority review, which if granted may shorten PyL’s regulatory review process from the usual 10 months to six. Lantheus expects the FDA's decision on this filing in early December. “The completion of our NDA submission marks a significant milestone for Lantheus and our PyL clinical development program,” Mary Anne Heino, president and CEO of Lantheus, said in a press release. “Prostate cancer is the second leading cause of cancer death in men. Fortunately, men can live for a long time with their disease if managed appropriately,” Heino said. "We believe that PyL, if approved, will play an ongoing role in the diagnosis and management of prostate cancer." PyL, also known as 18F-DCFPyl, is a tracing agent used in positron emission tomography or PET scans to visualize prostate cancer lesions in different types of tissues. It does this by targeting the prostate-specific membrane antigen (PSMA), a protein commonly found on the surface of prostate cancer cells. Once bound to these cells, PyL emits a radioactive signal that can be seen in PET scans, signaling where these lesions are located. The company’s NDA submission was supported by data from two clinical trials — OSPREY (NCT02981368) and CONDOR (NCT03739684) — that showed PyL can detect local and distant prostate cancer lesions that conventional imaging methods sometimes miss. Such detection makes tracking disease recurrence and spread more accurate, enabling doctors to adjust treatment plans appropriately. In the Phase 2/3 OSPREY tr
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