FDA approves darolutamide for patients with non-metastatic castration-resistant prostate cancer

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The US drug agency (FDA) has approved darolutamide, a non-steroidal androgen receptor antagonist, under the trade name of Nubeqa.

The FDA-approved indication is the treatment of patients with castration-resistant non-metastatic prostate cancer (CPRCnm), and is based on data from the phase III ARAMIS study evaluating darolutamide plus androgen deprivation treatment (ADD) versus placebo plus ADD and that demonstrated a highly significant improvement in the main objective of efficacy, metastasis-free survival (SLM), with a median of 40.4 months versus 18.4 months for placebo plus ADD (p <0.0001).

Darolutamide, which is being jointly developed by Bayer and Orion Corporation, has been approved by the FDA for the Priority Review procedure, which is reserved for drugs that, if approved, imply significant improvements in the safety or efficacy of the treatment, diagnosis or prevention of serious diseases.

“Patients in this stage of prostate cancer generally have no symptoms of the disease. The general objectives of treatment in this context are to delay the progression of prostate cancer and limit the possible adverse effects of treatment, ”said Matthew Smith, head of the Department of Genitourinary Tumors, of the Massachusetts General Hospital. “This authorization is a new treatment option relevant for doctors and patients with prostate cancer.”

“With the approval of darolutamide we have a new treatment that increases metastasis-free survival (SLM) and gives doctors greater flexibility to treat men living with CPRCnm,” adds Robert LaCaze, Head of the Oncology Unit from Bayer.


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