Bayer Announces EU Approval of Darolutamide for Metastatic Hormone-Sensitive Prostate Cancer

On March 1, Bayer announced that the European Commission has approved the new indication marketing application for oral androgen receptor inhibitor darolutamide in combination with androgen deprivation therapy (ADT) and docetaxel for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).

This approval is based on the positive results of the Phase III ARASENS study. The study showed that, compared to placebo combined with ADT and docetaxel, darolutamide combined with ADT and docetaxel significantly reduced the risk of death by 32.5% in patients with mHSPC. Additionally, the darolutamide combination therapy demonstrated consistent benefits across clinically relevant secondary endpoints, with a similar incidence of adverse events observed between the treatment groups overall.

Previously, darolutamide had been approved for the treatment of non-metastatic castration-resistant prostate cancer patients at high risk of metastasis. In 2022, due to continuous penetration in the global market and the ongoing expansion of combination therapies, darolutamide achieved strong growth with sales reaching 466 million euros (+112.8%). At the 2023 JPM Conference, Bayer's CEO expressed optimism about darolutamide’s market prospects and predicted that its peak sales would reach 3 billion euros.

"Today's approval of darolutamide is an important milestone in addressing the unmet medical needs of mHSPC patients in Europe," said Christine Roth, member of the Executive Committee of Bayer's Pharmaceuticals Division and Head of the Oncology Strategic Business Unit. "We are committed to improving care across all stages of prostate cancer and recognize that enhancing quality of life is just as important as extending survival and delaying disease progression for patients and their families. We will continue to fulfill our mission to redefine what it means to live with prostate cancer."

Copyright © 2023 PHARMCUBE. All Rights Reserved.

Welcome to forward, share, and reasonably cite. When citing, please clearly indicate the source of the article in a prominent position; if you need to reprint, please leave a message or send a notification to the WeChat Official Account backend, and include the name and ID of the official account.

Disclaimer: The information in this WeChat article is for general reference only and should not be directly used as decision-making content. PharmaCube assumes no responsibility for any loss incurred by any party due to the use of the content herein.

Exciting Live Broadcast

CUBE LIVE