FDA Approves Additional Indication for Nubeqa

The FDA has approved a supplemental new drug application (sNDA) for Bayer’s Nubeqa (darolutamide) with docetaxel for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC). Nubequa is oral an androgen receptor inhibitor that is also approved to treat non-metastatic castration-resistant prostate cancer.

Matthew Smith, M.D., Ph.D.

“This new indication for NUBEQA Nubeqa is particularly meaningful, as it highlights its proven tolerability and provides a new option for patients,” Matthew Smith, M.D., Ph.D., director of the Genitourinary Malignancies Program, Massachusetts General Hospital Cancer Center, said in a press release.

The approval was made under the FDA’s Real-Time Oncology Review (RTOR) pilot program based on results of the phase 3 ARASENS trial. Results demonstrated a statistically significant increase in overall survival (OS), the trial’s primary endpoint, with a reduction in the risk of death by 32% for those treated with Nubeqa plus androgen deprivation therapy (ADT) and docetaxel compared to ADT and docetaxel. Treatment with Nubeqa plus androgen deprivation therapy and docetaxel also resulted in a statistically significant delay in time to pain progression.

The ARASENS results were presented earlier this year at the 2022 ASCO GU Cancers Symposium and simultaneously published in The New England Journal of Medicine.

Incidence of adverse reactions was similar between both study arms. Adverse reactions reported for Nubeqa with docetaxel above 10% were constipation, decreased appetite, rash, hemorrhage, increased weight, and hypertension. Serious adverse reactions occurred in 45% of patients receiving Nubeqa and in 42% of patients receiving placebo. Fatal adverse reactions occurred in 4% of patients receiving Nubeqa and in 4% of patients receiving placebo.

Nubeqa is being investigated other studies across various stages of prostate cancer.