Now Approved in Doublet Combination: NUBEQA® + ADT for use in mHSPC patients1
As the only androgen receptor inhibitor (ARI) approved by Swissmedic, NUBEQA offers you the flexibility to treat your mHSPC patients either in combination with chemotherapy or without.1-8
NUBEQA is indicated in combination with androgen deprivation therapy (ADT) for the treatment of adult patients with metastatic, hormone-sensitive prostate cancer (mHSPC)1
ARANOTE – primary publication
Saad et al. J Clin Oncol. 2024 Dec 20;42(36):4271-4281.
Patients on Nubeqa with low baseline PSA (<4.1 ng/mL) had a lower risk of radiological progression or death vs. patients with baseline PSA ≥21.3 ng/mL9
Fred Saad, MD, shares phase 3 ARANOTE findings by disease volume
In this video, Fred Saad, MD, FRCS, shares key findings from the study, “Darolutamide plus ADT in patients with metastatic hormone-sensitive prostate cancer (mHSPC) by disease volume: Subgroup analysis of the phase 3 ARANOTE trial,” which was presented at the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco, California.
ARANOTE – Subgroup analysis by disease volume
Saad et al. J Clin Oncol. 2025 Feb 18;43(5):suppl
NUBEQA delayed the decline in the HRQoL of mHSPC patients versus Placebo10
ARANOTE – Health-related quality of life (HRQoL) outcomes
Morgans et al. J Clin Oncol. 2025;43(16):suppl.5004
PRESCRIBE WITH CONFIDENCE
Choose NUBEQA for strong efficacy and proven tolerability1-5
NUBEQA with low Drug-Drug Interaction (DDI) potentials
Find more about DDIs on the NUBEQA page
Materials & Resources for your practice
Find other publications about NUBEQA and patient materials for your practice here.
*ARI = Androgen receptor inhibitor
ADT - Androgen deprivation therapy
- Nubeqa® Fachinformation, www.swissmedicinfo.ch
- Smith MR, et al. ARASENS Trial Investigators. Darolutamide and survival in metastatic, hormone-sensitive prostate cancer. N Engl J Med 2022 386(12):1132–1142.
- Fizazi K, et al. Darolutamide in nonmetastatic, castration-resistant prostate cancer. N Engl J Med 2019;380(13):1235–1246.
- Fizazi K, et al. Nonmetastatic, castration-resistant prostate cancer and survival with darolutamide. N Engl J Med 2020;383(11):1040–1049.
- Saad F, et al. Darolutamide in Combination With Androgen-Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer From the Phase III ARANOTE Trial. J Clin Oncol . 2024 Dec 20;42(36):4271-4281.
- Erleada® Fachinformation, www.swissmedicinfo.ch
- Xtandi® Fachinformation, www.swissmedicinfo.ch
- Zytiga® Fachinformation, www.swissmedicinfo.ch
- Saad F, et al. Prostate-specific antigen response with darolutamide plus androgen-deprivationtherapy in patients with metastatic hormone sensitive prostate cancer in ARANOTE. Presentedat European Association of Urology; March 21–24, 2025; Madrid, Spain.
- Morgans AK et al. Health-related quality of life (HRQoL) outcomes with darolutamide in the phase 3 ARANOTE trial. 2025 ASCO (American Society of Clinical Oncology) Annual Meeting, Chicago USA, 30.5.–3.6. 2025, Abstract 5004. Oral Presentation by Dr. Alicia K. Morgans.
- Bolek H et al. Androgen receptor pathway inhibitors and drug-drug interactions in prostate cancer. ESMO Open. 2024 Nov;9(11):103736.
The referenced data, respectively publications, are available upon request.
AS.: Darolutamide. I.: NUBEQA is indicated in comb. with androgen deprivation therapy (ADT) for the treatm. of adult pat. with metastatic hormone-sensitive prostate cancer (mHSPC). NUBEQA is indicated in comb. with docetaxel and ADT for the treatm. of adult pat. with mHSPC, for whom docetaxel therapy is indicated. NUBEQA is indicated in comb. with ADT for the treatm. of adult pat. with non-metastatic, castration-resistant prostate cancer (nmCRPC), for those who are at high risk of develop. metastases (especially with a PSA-DT ≤ 10 m.). D/A: 600 mg (two 300 mg film-coated tablets) taken 2/day with a meal (total daily dose of 1200 mg). pat. receiving NUBEQA should also receive an LHRH agonist or antagonist concurrently or have had a bilat. orchiectomy. When used in comb. with docetaxel, the 1. of 6 docetaxel cycles should begin within 6 weeks of starting NUBEQA. CI.: Hypersensitivity to the active pharmaceut. ingredient or to one of the excipients. Women who are pregnant or of childbearing potential. Spec.W./Prec.: Renal/hepatic impairment: Closely monitor pat. with severe renal impair. or moderate/severe hepatic impair. for adverse reactions. Hepatotox.: In case of liver funct. test abnormalities suggestive of idiosyncr. DILI, NUBEQA must be permanently discont. ADT can prolong the QT interval: In case of risk factors or concomitant medication that prolong the QT interval, ECG monitoring should be consid.. Contraception: Sexually active pat. must use a highly effective form of contracept.. Bone density: may be affected during treatm. with NUBEQA due to long-term testosterone suppr. Recent cardiovasc. disease: The safety of NUBEQA in pat. with a clinic. relevant cardiovasc. disease in the last 6 months has not been proven, follow current guidelines. The prescr. dose is practically “sodium free”. Do not take if you have hereditary galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption. AEs.: NUBEQA: Very common: Neutrophil count decr., AST and ALT incr., bilirubin incr., fatigue. Common: Ischaemic heart disease, cardiac failure, rash, pain in extremities, fractures. NUBEQA in comb. with docetaxel: Very common: Hypertension including occasional hypertensive emergency, AST incr., ALT incr., bilirubin incr., rash. Interactions: BCRP inhibitor, OATP 1B1 and 1B3, in the case of concurrent use with corresp. substrates, follow the recommendations in the resp. prescrib. information. Weak CYP3A4 inducer. Substrate of CYP3A4, P-gp, and BCRP. Use of strong CYP3A4 inducers and P-gp inducers during treatm. with NUBEQA should be avoided. UE: Very common: Neutrophil count decreased, AST and ALT increased, Bilirubin increased, Fatigue. Common: Ischaemic heart disease, Cardiac failure, Rash, Pain in extremities, Fractures. NUBEQA in combination with Docetaxel: Very common: Hypertension including hypertensive emergency, AST increased, ALT increased, Bilirubin increased, Rash. List: B. Bayer (Schweiz) AG, 8045 Zurich. Further inform.: www.swissmedicinfo.ch.
RP-M_DAR-CH-0108-3 07/2025
PP-NUB-CH-0359-1_07.2025
