Bayer's Darolutamide Combination Therapy Receives FDA Priority Review for Significantly Extending Survival in mHSPC Patients

Recently, Bayer announced that the U.S. FDA has granted priority review status to the supplemental New Drug Application (sNDA) for darolutamide, an oral androgen receptor inhibitor (ARi), in combination with docetaxel for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). This application will be reviewed under the FDA's Oncology Center of Excellence’s Orbis pilot project.

Prostate cancer is the second most commonly diagnosed malignancy in men worldwide. In 2020, an estimated 1.4 million men were diagnosed with prostate cancer, and approximately 375,000 men died from the disease globally. At diagnosis, most men have localized prostate cancer, which can be treated with surgery or radiation therapy. When the disease metastasizes or spreads, it develops into metastatic prostate cancer. The growth of prostate cancer cells is androgen-dependent; therefore, patients with metastatic prostate cancer are initially sensitive to androgen deprivation therapy (ADT), referred to as mHSPC. Patients who experience disease progression despite continuous ADT will develop metastatic castration-resistant prostate cancer (mCRPC).

Darolutamide is an oral androgen receptor inhibitor with a unique chemical structure that binds to the androgen receptor with high affinity, exhibiting strong antagonistic activity, thereby inhibiting receptor function and the growth of prostate cancer cells. Darolutamide, jointly developed by Bayer and Orion, has been approved under the English brand name Nubeqa in over 60 countries and regions worldwide, including the United States, the European Union, Japan, and China, for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC). Bayer has recently submitted applications to the European Medicines Agency (EMA), Japan's Ministry of Health, Labour and Welfare (MHLW), and the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration, with plans to file additional regulatory applications globally for the mHSPC indication.

This priority review status is based on positive results from the pivotal Phase 3 ARASENS clinical trial. In this randomized, double-blind, placebo-controlled Phase 3 clinical trial, 1,306 newly diagnosed patients were randomly assigned in a 1:1 ratio to receive either 600 mg of darolutamide twice daily or placebo, in addition to ADT and docetaxel. The trial results demonstrated that adding darolutamide to the treatment regimen of ADT and docetaxel significantly increased the overall survival (OS) of patients with mHSPC. These trial results have been published in The New England Journal of Medicine.

References:

1. U.S. FDA accepts supplemental new drug application (sNDA) and grants priority review for darolutamide in combination with docetaxel for metastatic hormone-sensitive prostate cancer (mHSPC). Retrieved May 3, 2022, from https://media.bayer.com/baynews/baynews.nsf/id/US-FDA-accepts-supplemental-application-sNDA-grants-priority-review-darolutamide-combination?OpenDocument&sessionID=1651714257

(Original text has been abridged)

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