Bayer Submits Supplemental New Drug Application to U.S. FDA Seeking Expanded Indication for NUBEQA® (darolutamide) in Metastatic Hormone-Sensitive Prostate Cancer [Yahoo! Finance]
ORION CORP NEW UNSP/ADR (ORINY)
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Source: Yahoo! Finance
"Simply put, our ambition is to help more patients with prostate cancer," said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. "We are proud of the role NUBEQA currently plays in the treatment of mHSPC and with this FDA submission, hope to expand the use of NUBEQA to more patients with the disease, regardless of chemotherapy use." The submission is based on positive results from the investigational pivotal Phase III ARANOTE trial. Data from the trial were presented at the 2024 European Society for Medical Oncology (ESMO) Congress and published in The Journal of Clinical Oncology NUBEQA is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company. About the ARANOTE Trial The ARANOTE trial (NCT04736199) was a randomized, double-blind, placebo-controlled Phase III study designed to assess the efficacy and safety of NUBEQA plus androgen dep
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