Darolutamide Now Approved as Single Agent for MCSPC

The US Food and Drug Administration (FDA) has approved single-agent darolutamide (Nubeqa, Bayer Healthcare Pharmaceuticals, Inc.) for the treatment of metastatic castration–sensitive prostate cancer (mCSPC).

Darolutamide, an androgen receptor inhibitor, was previously approved in combination with docetaxel chemotherapy for mCSPC. The new single-agent approval is based on safety and survival outcomes in the randomized, placebo-controlled phase 3 ARANOTE trial, which evaluated darolutamide without docetaxel, according to the FDA approval notice.

Median radiographic progression-free survival, a major efficacy outcome in the global double-blind trial, was significantly better in 446 patients with mCSPC who were randomized to the treatment group compared with 223 in the placebo group (not reached vs 25 months; Hazard Ratio [HR], 0.54).

No significant difference was observed between the groups in overall survival, an additional efficacy measure, at the final analysis (HR, 0.78).

Study participants were randomized 2:1 to receive 600 mg of darolutamide twice daily plus androgen deprivation therapy (ADT) or placebo plus ADT.

All patients received a gonadotropin-releasing hormone analog concurrently or had prior bilateral orchiectomy.

Adverse reactions were consistent with those seen previously with single-agent darolutamide. Current prescribing information, which can be found at Drugs@FDA, includes warnings and precautions for ischemic heart disease, seizure, and embryo-fetal toxicity.

The recommended dose of darolutamide is 600 mg given orally as two 300 mg tablets twice daily with food until disease progression or unacceptable toxicity.

Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, writing for Medscape, MDedge, and other affiliate sites. She currently covers oncology, but she has also written on a variety of other medical specialties and healthcare topics. She can be reached at [email protected] or on X: @SW_MedReporter.