Food and Drug Administration (FDA) has announced the approval of darolutamide for metastatic castration-sensitive prostate cancer (mCSPC).

The FDA previously approved darolutamide in combination with docetaxel for mCSPC.

Efficacy was evaluated in ARANOTE (NCT02799602), a randomised, double-blind, placebo-controlled trial in 669 patients with mCSPC.

Patients received either darolutamide or placebo. All patients received a gonadotropin-releasing hormone analogue concurrently or had prior bilateral orchiectomy.

The major efficacy outcome was radiographic progression-free survival (rPFS) assessed by blinded independent central review.

Overall survival (OS) was an additional efficacy outcome.

Treatment with darolutamide resulted in a statistically significant improvement in rPFS compared to placebo. Median rPFS was not reached in the darolutamide arm and was 25 months (95% CI: 19, NR) in the placebo arm (hazard ratio [HR] 0.54; 95% CI: 0.41, 0.71; p-value <0.0001).

There was no statistically significant improvement in OS at the final analysis (HR 0.78; 95% CI: 0.58, 1.05).

Adverse reactions were consistent with prior experience with darolutamide as a single agent.

The darolutamide prescribing information includes warnings and precautions for ischemic heart disease, seizure, and embryo-fetal toxicity. 

The recommended darolutamide dose is 600 mg (two 300 mg tablets) taken orally, twice daily, with food until disease progression or unacceptable toxicity.

This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence.

Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners.

For this review, FDA collaborated with the Australian Therapeutic Goods Administration, Health Canada, Switzerland’s Swissmedic, and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency.

The application reviews are ongoing at the other regulatory agencies. 

Source: FDA