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Nubeqa FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 31, 2022.

FDA Approved: Yes (First approved July 30, 2019)
Brand name: Nubeqa
Generic name: darolutamide
Dosage form: Tablets
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Prostate Cancer

Nubeqa (darolutamide) is an androgen receptor inhibitor (ARi) used in the treatment of prostate cancer.

  • Nubeqa is indicated for the treatment of adult patients with:
    • non-metastatic castration-resistant prostate cancer (nmCRPC).
    • metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel.
  • Nubeqa tablets are administered orally, twice a day.
  • Warnings and precautions associated with Nubeqa include ischemic heart disease, seizures, and embryo-fetal toxicity.
  • Common adverse reactions in nmCRPC include fatigue, pain in extremities, and rash. Common laboratory test abnormalities include increased AST, decreased neutrophil count, and increased bilirubin.
    Common adverse reactions in mHSPC include constipation, decreased appetite, rash, hemorrhage, weight increase, and hypertension. Common laboratory test abnormalities include anemia, hyperglycemia, decreased lymphocyte count, decreased neutrophil count, increased AST, increased ALT, and hypocalcemia.

Development timeline for Nubeqa

Aug  5, 2022Approval U.S. FDA Approves Additional Indication of Nubeqa (darolutamide) in Combination with Docetaxel for the Treatment of Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Jul 30, 2019Approval FDA Approves Nubeqa (darolutamide) for Men with Non-Metastatic Castration-Resistant Prostate Cancer
Apr 29, 2019U.S. FDA Accepts New Drug Application and Grants Priority Review for Darolutamide
Feb 27, 2019Bayer Completes Rolling Submission of NDA for Investigational Drug Darolutamide for the Treatment of Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC)
Oct 24, 2018Phase III Trial of Darolutamide in Patients with Non-metastatic Castration-resistant Prostate Cancer Meets Primary Endpoint

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.