Home Cancer PharmaWatch: Bayer Completes Rolling FDA Drug Application for Darolutamide for nmCRPC

PharmaWatch: Bayer Completes Rolling FDA Drug Application for Darolutamide for nmCRPC


Bayer, based in Germany, announces they have completed a rolling submission of New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational drug darolutamide. The submission was initiated in December 2018 and backed by him Phase III ARAMIS trial in men with non-metastatic castration-resistant prostate cancer. (nmCRPC). The data was recently presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) in San Francisco and published simultaneously in the New England Journal of Medicine.

What was the ARAMIS Trial?

A randomized, Phase III, multi-center, double-blind, placebo-controlled trial in evaluating the safety and efficacy of oral darolutamide in patients with nmCRPC who are currently being treated with androgen deprivation therapy (ADT) as a standard of care and are at high risk for developing metastatic disease. The German industry sponsor included 1,509 randomized patients (2:1 ratio) to receive 600 mg of the medicine twice a day or placebo along with ADT.

The primary endpoint of this trial is metastasis-free survival (MFS) defined as time between randomization and evidence of metastasis or death. The secondary endpoints of this trial are overall survival (OS), time to pain progression, time to initiation of first cytotoxic chemotherapy, time to first symptomatic skeletal event (SSE), and characterization of the safety and tolerability of darolutamide.

What is Darolutamide?

Darolutamide is an investigational, non-steroidal androgen receptor antagonist with a chemical structure that binds to the receptor and exhibits antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells. A Phase 3 study in metastatic hormone-sensitive prostate cancer (ARASENS) is ongoing. Information about these trials can be found at www.clinicaltrials.gov.

What About Castration-Resistant Prostate Cancer (CPRC)?

According to sponsor Bayerprostate cancer is the second most commonly diagnosed malignancy in men worldwide. In 2018, an estimated 1.2 million men were diagnosed with prostate cancer, and about 358,000 died from the disease worldwide. Prostate cancer is the fifth leading cause of death from cancer in men. Prostate cancer results from the abnormal proliferation of cells within the prostate gland, which is part of a man’s reproductive system. It mainly affects men over the age of 50, and the risk increases with age. 

Treatment options range from surgery to radiation treatment to therapy using hormone-receptor antagonists, i.e., substances that stop the formation of testosterone or prevent its effect at the target location. However, in nearly all cases, the cancer eventually becomes resistant to conventional hormone therapy. CRPC is an advanced form of the disease where the cancer keeps progressing even when the amount of testosterone is reduced to very low levels in the body. The field of treatment options for castration-resistant patients is evolving rapidly, but until recently, there have been no effective treatment options for CRPC patients who have rising prostate-specific antigen (PSA) levels while on ADT and no detectable metastases. In men with progressive nmCRPC, a short PSA doubling time has been consistently associated with reduced time to first metastasis and death.


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