FDA Approves Darolutamide, Docetaxel Combination for Metastatic Hormone-Sensitive Prostate Cancer

By Cecilia Brown - August 9, 2022

The U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application for darolutamide in combination with docetaxel for patients with metastatic hormone-sensitive prostate cancer.

Darolutamide, an oral androgen inhibitor known by the brand name Nubeqa, now has indication for metastatic hormone-sensitive prostate cancer in addition to its indication for non-metastatic castration-resistant prostate cancer in men at high risk of developing metastatic disease, Bayer announced. Darolutamide was developed jointly by Bayer and Orion.

The application received priority review by the FDA and was submitted to the FDA’s Real-Time Oncology Review pilot program, “which aims to provide a more efficient review process of applications to ensure that safe and effective cancer treatments are available to patients as early as possible,” Bayer officials said in a press release. The FDA Oncology Center of Excellence’s Project Orbis initiative is also conducting ongoing reviews, according to Bayer.

Approval Based on ARASENS Trial Results

The FDA approval is based on data from the randomized, multi-center, double-blind, placebo-controlled phase III ARASENS trial. The trial assessed 1,306 patients who were newly diagnosed with metastatic hormone-sensitive prostate cancer. They were randomized to receive darolutamide 600 mg twice daily, plus androgen-deprivation therapy (ADT) and docetaxel, or placebo plus ADT and docetaxel. The risk of death was significantly lower, by 32.5%, in patients who received darolutamide plus ADT and docetaxel compared to patients who received placebo plus ADT and docetaxel.

“Darolutamide was also associated with consistent benefits with respect to the secondary end points and prespecified subgroups,” Matthew Smith, MD, PhD, and colleagues wrote in The New England Journal of Medicine publication about the trial’s results.

Dr. Smith and colleagues reported similar rates of adverse events between the two groups, with 66.1% of patients receiving darolutamide and 63.5% of patients receiving placebo reporting grade 3 or grade 4 adverse events.

Continued Investigation Across Prostate Cancer Stages

Darolutamide has been approved in more than 70 markets, including the U.S., the European Union, Japan, and China, for patients with non-metastatic castration-resistant prostate cancer who are at high risk of developing metastatic disease, according to Bayer.

“The compound is also being investigated in further studies across various stages of prostate cancer,” Bayer officials said in a news release.

One example is the ARANOTE Phase III trial, which is assessing darolutamide plus ADT versus ADT alone for metastatic hormone-sensitive prostate cancer. The Australian and New Zealand Urogenital and Prostate Cancer Trials Group is also leading an international co-operative group Phase III trial that evaluates darolutamide as an adjuvant treatment for localized prostate cancer with very high risk of recurrence.


Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer

FDA Approves Additional Indication of Darolutamide in Combination With Docetaxel for the Treatment of Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

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