BAYER AG

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Darolutamide with ADT reduced risk of disease progression or death in metastatic HSPC, prompting FDA acceptance of sNDA. Radiological progression risk reduced by 46%, with similar safety profiles in darolutamide and placebo groups.

FDA accepts sNDA for darolutamide (Nubeqa) with ADT for metastatic hormone-sensitive prostate cancer, based on ARANOTE trial results. Darolutamide, an AR inhibitor, showed significant improvement in radiological progression-free survival and overall survival, with consistent benefits across subgroups. Adverse events were similar, with fewer discontinuations due to AEs in darolutamide group.

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Conference on global health and clinical trials addresses bioethics, regulations, patient recruitment, site selection, real-world data, data integration, outsourcing, vendor management, quality in trial conduct, risk-based monitoring, clinical auditing, financial planning, and innovative technologies. Focuses on networking, case studies, presentations, and round tables.

The FDA accepted an sNDA for darolutamide (Nubeqa) combined with ADT for metastatic hormone-sensitive prostate cancer (mHSPC), supported by the phase 3 ARANOTE trial. The trial showed a 46% reduced risk of radiographic progression or death with darolutamide/ADT vs placebo/ADT, meeting the primary endpoint. Darolutamide's safety profile remained consistent, with no new safety signals identified.

FDA accepts sNDA for darolutamide (Nubeqa) plus ADT for metastatic hormone-sensitive prostate cancer, based on ARANOTE trial data showing superior radiographic progression-free survival. Bayer aims to expand darolutamide's indication in mHSPC treatment.

The FDA accepted Bayer's sNDA for Nubeqa (darolutamide), an oral ARi for metastatic hormone-sensitive prostate cancer, based on positive Phase III ARANOTE trial results. Nubeqa, in combination with ADT, met the trial's primary endpoint of radiological progression-free survival. If approved, Nubeqa's indication would expand to include mHSPC with or without chemotherapy.

The Global Clinical Trials Connect 2025 conference will discuss futuristic advancements in clinical trials, focusing on innovative strategies, new technologies, and quality collaborations to address increased complexity. Topics include patient recruitment, site selection, real-world data, and risk-based monitoring, among others. The event targets senior-level professionals from pharmaceutical, bio-tech, and CRO companies, offering networking and case study opportunities.