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Lantheus Announces Publication of PyL™ (18F-DCFPyL) Results from Pivotal Studies
OSPREY Phase 2/3 Results Published in the Journal of Urology CONDOR Phase 3 Results Published in Clinical Cancer Research NORTH BILLERICA, Mass.--(BUSINESS
About this update from Lantheus Holdings, Inc.
[{"type":"text","content":"\nOSPREY Phase 2/3 Results Published in the Journal of Urology \n\nCONDOR Phase 3 Results Published in Clinical Cancer Research\n\n NORTH BILLERICA, Mass.--(BUSINESS WIRE)--\nLantheus Holdings, Inc. (NASDAQ: LNTH) (Lantheus), 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, today announced the publication of the results of both pivotal studies for PyL™, an investigational PET imaging agent that targets prostate-specific membrane antigen (PSMA). The OSPREY Phase 2/3 trial results have been published online in the Journal of Urology and the CONDOR Phase 3 trial results have been published in the online version of Clinical Cancer Research.\n\n“The limitations of conventional imaging modalities for prostate cancer create a need for targeted imaging in the initial assessment of high-risk patients as well as in men with early biochemically relapsed disease,” said Michael J. Morris, M.D., Prostate Cancer Section Head, Genitourinary Medical Oncology Service, Division of Solid Tumor Oncology, Memorial Sloan Kettering Cancer Center, and lead author of the CONDOR manuscript and senior author on the OSPREY manuscript. “The OSPREY trial data highlighted the high positive predictive value, negative predictive value and specificity of PyL in staging high-risk patients. The CONDOR trial demonstrates its high positive predictive value to accurately locate and identify recurrent cancer early and non-invasively. Assuming FDA approval, physicians will be able to use this clinically meaningful information to identify disease, guide treatment plans, and improve disease management.”\n\nMary Anne Heino, President and Chief Executive Officer of Lantheus added, “We believe these data demonstrate PyL’s clinical benefit and are honored to have our studies published in such well-respected peer-reviewed journals. The results of the OSPREY and CONDOR trials are part of our NDA that is currently under priority review at the FDA for marketing authorization in the United States. We believe PyL has the potential to play an important role in transforming the management of men with high-risk, recurrent or metastatic prostate cancer.”\n\nKenneth J. Pienta, M.D., Director of Research at the James Buchanan Brady Urolog...