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Lantheus Holdings Submits New Drug Application to the U.S. FDA for PyL™ (18F-DCFPyL), a PSMA-Targeted Prostate Cancer Imaging Agent
NORTH BILLERICA, Mass.--(BUSINESS WIRE)-- Lantheus Holdings, Inc. (the “Company”) (NASDAQ: LNTH), the parent company of Lantheus Medical Imaging, Inc. and
About this update from Lantheus Holdings, Inc.
[{"type":"text","content":" NORTH BILLERICA, Mass.--(BUSINESS WIRE)--\nLantheus Holdings, Inc. (the “Company”) (NASDAQ: LNTH), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for PyL™ (18F-DCFPyL), a prostate specific membrane antigen (PSMA)-targeted positron emission tomography (PET) imaging agent for prostate cancer. The NDA includes a request for Priority Review, which if granted, could shorten the FDA’s review of the NDA to six months from the time of acceptance, versus the standard review timeline of 10 months from acceptance. The Company expects to receive notification from the FDA confirming acceptance of the filing for substantive review in early December 2020.\n\n“The completion of our NDA submission marks a significant milestone for Lantheus and our PyL clinical development program,” said Mary Anne Heino, President and Chief Executive Officer of Lantheus. \"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. There are approximately 3.2 million men in the United States annually living with this disease.1 We believe that PyL, if approved, will play an ongoing role in the diagnosis and management of prostate cancer.”\n\nThe NDA is supported by data from two pivotal studies (OSPREY and CONDOR), designed to establish the safety and diagnostic performance of PyL imaging across the disease continuum of prostate cancer. Results from OSPREY Cohort A demonstrated improvement in specificity and positive predictive value (PPV) of PyL PET imaging over conventional imaging in men with high risk prostate cancer. OSPREY Cohort B and CONDOR studied men with prostate cancer in various disease states, including biochemical recurrent prostate cancer, hormone sensitive prostate cancer, non-metastatic castrate resistant prostate cancer, and metastatic castrate resistant prostate cancer. OSPREY Cohort B demonstrated a sensitivity in detecting metastatic lesions, while CONDOR, in patients with biochemical recurrent prostate cancer and non-informative baseline findings, demonstrated a h...