FDA Approves sNDA for Nubeqa With Docetaxel to Treat Hormone-Sensitive Prostate Cancer

The approval is based on results of the phase 3 study, ARASENS, that demonstrated a statistically significant increase in overall survival, the trial’s primary endpoint.

The FDA has approved a supplemental new drug application for the oral androgen receptor inhibitor, darolutamide (Nubeqa; Bayer) with docetaxel for the treatment of adult individuals with metastatic hormone-sensitive prostate cancer (mHSPC).

The approval is based on results of the phase 3 study, ARASENS (NCT02799602), that demonstrated a statistically significant increase in overall survival (OS), the trial’s primary endpoint.

There was also a reduction in the risk of death by 32% for those who were treated with darolutamide plus docetaxel and androgen deprivation therapy (ADT) compared with ADT and doxetaxel.

Additionally, treatment with darolutamide plus ADT and docetaxel also resulted in a statistically significant delay in time to pain progression.

“With compelling data from the phase 3 ARASENS and ARAMIS [NCT 02200614] trials, [darolutamide] has demonstrated significant efficacy in mHSPC and [non-metastatic castration-resistant prostate cancer (nmCRPC)],” Christine Roth, member of the executive committee of Bayer’s Pharmaceutical Division and head of the Oncology SBU at Bayer, said in a statement. “The expansion of [darolutamide]’s indication to reach a broader population in the US reaffirms Bayer’s commitment to provide proven and tolerable treatment options to eligible patients across different stages of prostate cancer.”

Investigators found that the incidence of adverse reactions (AEs) was similar between both study arms. AEs reported for darolutamide with docetaxel compared with the placebo were constipation at 23% and 20%, decreased appetite at 19% and 13%, hemorrhage at 18% and 13%, hypertension at 14% and 9%, increased weight at 18% and 16%, and rash at 19% and 15%, respectively.

Serious AEs occurred in approximately 45% of individuals receiving darolutamide and docetaxel and in 42% of those receiving the placebo and docetaxel. Fatal adverse reactions occurred in 4% of individuals receiving darolutamide and docetaxel and the placebo and docetaxel.

“[Darolutamide] plus ADT and docetaxel has shown significant benefit in [OS] and a favorable safety profile for patients with [mHSPC],” Matthew Smith, MD, PhD, director of the Genitourinary Malignancies program at the Massachusetts General Hospital Cancer Center, said in the statement. “This new indication for [darolutamide] is particularly meaningful, as it highlights its proven tolerability and provides a new option for patients.”

The ARASENS results were presented earlier this year at the 2022 American Society of Clinical Oncology Genitourinary Cancers Symposium and published in The New England Journal of Medicine.

Darolutamide is also indicated for nmCRPC and is being investigated in further studies across various stages of prostate cancer.

The application received priority review designation granted by the FDA and was submitted under the FDA’s Real-Time Oncology Review pilot program. The program is intended to provide a more efficient review process of applications to ensure that effective and safe cancer treatments are available as early as possible for patients.

Further, ongoing reviews are being conducted under the FDA Oncology Center of Excellence’s Project Orbis initiative, which provides a framework for concurrent submissions and reviews of cancer treatments.

Reference

US FDA approves additional indication for Nubeqa (darolutamide) in combination with docetaxel for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC). News release. August 5, 2022. Accessed August 8, 2022. https://www.businesswire.com/news/home/20220805005477/en