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Following the positive recommendation, the European Commission will now review the application for vibegron for potential approval in the OAB setting in all EU member states, as well as in Iceland, Liechtenstein, and Norway.

Prostate cancer, 3D illustration showing presence of tumor inside prostate gland which compresses urethra | Image Credit: @ Dr_Microbe - stock.adobe.com

The approval is supported by data from the phase 3 EMBARK trial, which demonstrated that enzalutamide with or without leuprolide prolonged metastasis-free survival compared with leuprolide alone in patients with high-risk biochemically recurrent nmHSPC.

“These findings suggest that guideline recommended treatment intensification remains low for patients with mCSPC in both Medicare and the Veterans Health Administration, but especially for Black patients,” says Daniel J. George, MD.