FDA approves an sNDA for Nubeqa plus docetaxol in metastatic hormone-sensitive prostate cancer.- Bayer
Bayer announced the FDA has approved a supplemental New Drug Application (sNDA) for the oral androgen receptor inhibitor (ARi) Nubeqa (darolutamide) with docetaxel for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC).
The approval is based on results of the Phase III ARASENS trial that 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 (HR=0.68, 95% CI 0.57-0.80; P<0.0001). treatment with nubeqa plus adt and docetaxel also resulted in a statistically significant delay in time to pain progression (hr="0.79," 95% ci 0.66-0.95; p="0.006)."></0.0001).>
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. Nubeqa is also indicated for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC). Nubeqa is being investigated in further studies across various stages of prostate cancer.
Incidence of adverse reactions was similar between both study arms. Adverse reactions reported for Nubeqa with docetaxel above 10% with an at least 2% increase over placebo with docetaxel were constipation (23% versus 20%), decreased appetite (19% versus 13%), rash (19% versus 15%), hemorrhage (18% versus 13%), increased weight (18% versus 16%), and hypertension (14% versus 9%). Serious adverse reactions occurred in 45% of patients receiving Nubeqa with docetaxel and in 42% of patients receiving placebo with docetaxel. Fatal adverse reactions occurred in 4% of patients receiving Nubeqa with docetaxel and in 4% of patients receiving placebo with docetaxel.
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