FDA Expedites Review of Nubeqa Combination for Metastatic, Hormone-Sensitive Prostate Cancer

The drug combination of Nubeqa (darolutamide) plus docetaxel was granted a priority review for a supplemental new drug application for the treatment of patients with metastatic hormone-sensitive prostate cancer, according to Bayer, the drug manufacturer behind Nubeqa.

The Food and Drug Administration (FDA) grants priority reviews to therapies that are particularly promising and fill an unmet need. In doing so, the agency agrees to speed up the review process that could potentially lead to FDA approval.

The priority review is based on findings from the phase 3 ARASENS clinical trial, which showed that treatment with Nubeqa, docetaxel and androgen-deprivation therapy improved overall survival (time from treatment to death from any cause) compared with placebo, docetaxel plus androgen-deprivation therapy in patients with metastatic hormone-sensitive prostate cancer. The findings were recently published in the New England Journal of Medicine.

The trial included 1,306 patients (651 who were randomized to the Nubeqa group, and 655 who were randomized to the placebo group), with the majority (86.1%) having metastatic disease at the time of diagnosis.

Patients who received the Nubeqa-containing regimen had a 32.5% lower risk of death compared to those assigned to the placebo-containing combination.

Side effects were similar between the two groups, with 66.1% and 63.5% of patients experiencing severe (grade 3 or 4) side effects in the Nubeqa and placebo groups, respectively. The most common severe side effect in both groups was neutropenia, which occurs when there is too few neutrophils (a type of white blood cell) in the body.

Read more: Even in the Prescence of Health Complications and Other Medications, Nubeqa Maintains Safety, Efficacy in Prostate Cancer Treatment

The priority review was granted under the FDA Oncology Center of Excellence (OCE) Project Orbis, which is a collaborative effort among the FDA and drug regulation authorities from other countries that are simultaneously reviewing oncology products. In doing so, patients with cancer may be able to receive access to drugs earlier, while also establishing a more global, standardized approach for cancer treatment.

“Today’s (supplemental new drug application) acceptance, confirmation of Priority Review and participation in Project Orbis, bring us closer to adding a new indication for Nubeqa in combination with docetaxel to benefit men with (metastatic hormone-sensitive prostate cancer),” said Christine Roth, a member of the Executive Committee of Bayer’s Pharmaceutical Division and Head of the Oncology SBU at Bayer, in a press release.

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