Bayer’s darolutamide endorsed by CHMP for treating metastatic hormone-sensitive prostate cancer

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Berlin, January 27, 2023 – Incredible news! The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has given the thumbs up to darolutamide, an oral androgen receptor inhibitor (ARi), plus ADT in combination with docetaxel for marketing authorization in the European Union (EU) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). Darolutamide is already approved under the brand name Nubeqa™ for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease.

Christine Roth, Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of the Oncology Strategic Business Unit, said “This positive CHMP opinion underscores darolutamide’s potential to set a new standard of care for eligible patients living with prostate cancer.”

“Despite significant advances, for many men with mHSPC, disease progression and the onset of debilitating symptoms remain commonplace. It is therefore critical that these patients have access to treatment options that can not only improve mortality but also delay the time to symptom progression.” said Prof. Bertrand Tombal, Professor of Urology.

The final decision from the European Commission on the marketing authorization is expected soon. Darolutamide is being investigated in a broad development program with additional three ongoing or planned large clinical studies, to investigate its potential across prostate cancer patients from the early- to the late-stage of this disease.

Prostate cancer is the most commonly diagnosed cancer in men in almost all northern and western European countries. Only 30% of men with mHSPC will survive five years or more after diagnosis. Most men with mHSPC eventually progress to metastatic castration-resistant prostate cancer (mCRPC), a condition with limited long-term survival. Darolutamide is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

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