Bayer’s Nubeqa drug won priority review status from the U.S. Food and Drug Administration, as the German drugmaker seeks to widen the use of the prostate cancer drug from an early disease stage to metastatic cases.
BioSpace Global Roundup: Jan. 30, 2020
Alopecia, Anti-GBM Antibody Disease (Goodpasture´s Disease), Approvals, Bacteria, Business, Cancer, Clinical Trials, Deals, Diagnostics, Drug Discovery, European Commission, FDA/Regulatory, Hair Loss, Metastatic Hormone-Sensitive Prostate Cancer (mHSPC), New Indications, PD-1/PD-L1 inhibitors, Product Pipelines, R&D, TumorsPharma companies from across the globe provide updates on their pipelines and business.
The U.S. Food and Drug Administration accepted for review Astellas Pharma Inc.’s filing of a supplemental New Drug Application for Xtandi (enzalutamide) to add an indication for the treatment of men with metastatic hormone-sensitive prostate cancer.
Phase 3 ARCHES Trial Shows Xtandi Significantly Improved Radiographic Progression-Free Survival in Men with mHSPC
Androgen Deprivation Therapy (ADT), Clinical Data, Clinical Trials, CYP2C8 inhibitors, Metastatic Castration-Resistant Prostate Cancer (mCRPC), Metastatic Hormone-Sensitive Prostate Cancer (mHSPC), R&D, TestosteronePfizer Inc. and Astellas Pharma Inc. announced results from the Phase 3 ARCHES trial in men with metastatic hormone-sensitive prostate cancer (mHSPC).