April 29, 2019
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FDA grants priority review to darolutamide for prostate cancer subtype

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The FDA granted priority review to darolutamide for the treatment of men with nonmetastatic castration-resistant prostate cancer, according to the agent’s manufacturers.

Darolutamide (BAY-1841788, ODM-201; Bayer, Orion Pharma) is a nonsteroidal androgen receptor antagonist that binds to the receptor, inhibiting the growth of prostate cancer cells.

“Bayer is committed to addressing treatment gaps that exist along the continuum of care for men with prostate cancer,” Scott Z. Fields, MD, senior vice president and head of oncology development at Bayer’s Pharmaceutical Division, said in a press release. “With the [new drug application] acceptance and priority review designation, we are an important step closer to bringing darolutamide to patients as quickly as possible.”

The decision was based, in part, on data from the multicenter, double-blind, placebo-controlled phase 3 ARAMIS trial. The analysis included 1,509 men with nonmetastatic castration-resistant prostate cancer receiving standard-of-care androgen deprivation therapy who were at high risk for metastases.

Researchers randomly assigned the men 2:1 to receive 600 mg darolutamide twice daily or placebo along with ADT.

Metastasis-free survival served as the study’s primary endpoint.

As HemOnc Today previously reported, darolutamide conferred a 59% reduction in the risk for metastases or death (median metastasis-free survival, 40.4 months vs. 18.4 months; HR = 0.41; 95% CI, 0.34-0.5).

Most adverse events were grade 1 or grade 2. Twenty-five percent of men assigned darolutamide and 20% assigned placebo experienced grade 3 or grade 4 adverse events.