NEW INDICATION: FDA-APPROVED WITHOUT DOCETAXEL IN mCSPC

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For your patients with metastatic castration-sensitive prostate cancer (mCSPC) or non-metastatic castration-resistant prostate cancer (nmCRPC)

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POWERFUL EFFICACY AND PROVEN TOLERABILITY IN THREE PHASE III TRIALS1-5

mCSPC

metastatic castration-sensitive prostate cancer

ARANOTE: NUBEQA + ADT Arasens: NUBEQA + ADT + DOCETAXEL

nmCRPC

non-metastatic castration-resistant 
prostate cancer

ARAMIS: NUBEQA + ADT

POWERFUL EFFICACY AND PROVEN TOLERABILITY IN THREE PHASE III TRIALS1-5

  • ARANOTE: In mCSPC, NUBEQA + ADT demonstrated a 46% reduction in risk of progression or death vs ADT alone; HR: 0.54; 95% CI: 0.41-0.71; P<0.0001. rPFS* was the primary endpoint1,2
  • ARASENS: In mCSPC, NUBEQA + ADT + docetaxel significantly extended OS beyond docetaxel + ADT; HR: 0.68; 95% CI: 0.57-0.80; P<0.0001. OS was the primary endpoint1
  • ARAMIS: In nmCRPC, NUBEQA + ADT significantly increased MFS vs ADT alone; HR: 0.41; 95% CI: 0.34-0.50; P<0.0001. MFS† was the primary endpoint. OS was a key secondary endpoint1
ARANOTE Safety & Tolerability

NEW DATA

ARASENS Safety & Tolerability
ARAMIS Safety & Tolerability

ARANOTE Study Design: A multicenter, double-blind, placebo-controlled, phase III study in 669 patients with mCSPC. Patients were randomized 2:1 to receive 600 mg NUBEQA twice daily (N=446) or placebo (N=223) concomitantly with ADT‡. Treatment with NUBEQA or placebo continued until progressive disease, change of antineoplastic therapy, unacceptable toxicity, death, or withdrawal. The primary endpoint was radiographic progression-free survival (rPFS), defined as the time from randomization to radiological disease progression or death by central blinded review. rPFS was statistically significant for the NUBEQA arm vs placebo arm (HR: 0.54; 95% CI: 0.41-0.71; P<0.0001).1,2

Rates of permanent discontinuation, dosage interruption, and dosage reduction due to AEs with NUBEQA were 6%, 14%, and 3.6%, respectively. Most frequent reasons for permanent discontinuation: increased ALT, increased AST, craniocerebral injury, myocardial infarction, and rash (all with 0.4%). Most frequent reasons for dosage interruption: increased AST (1.6%), increased ALT (1.3%), and rash (1.3%). Most frequent reasons for dosage reduction: increased AST (0.7%), rash (0.7%), increased ALT (0.4%), and hypertension (0.4%).1

ARASENS Study Design: A multicenter, double-blind, phase III trial of 1305 patients with mCSPC. Patients were randomized 1:1 to receive 600 mg NUBEQA twice daily (N=651) or placebo (N=654) concomitantly with ADT‡ and 75 mg/m² of docetaxel every 21 days for 6 cycles. ADT‡ was started within 12 weeks before randomization; docetaxel was started within 6 weeks after randomization. OS was statistically significant for the NUBEQA arm vs the placebo arm (HR: 0.68; 95% CI: 0.57-0.80; P<0.0001).1,3 

Rates of permanent discontinuation, dosage interruption, and dosage reduction due to AEs with NUBEQA were 14%, 23%, and 9%, respectively. Most frequent reasons for permanent discontinuation: rash (1.1%), musculoskeletal pain (0.9%), and increased AST (0.9%). Most frequent reasons for dosage interruption: increased ALT (3.2%), increased AST (3.1%), and febrile neutropenia (2.1%). Most frequent reasons for dosage reduction: increased ALT (2.8%) and increased AST (2.5%).1

ARAMIS Study Design: A multicenter, double-blind, phase III trial of 1509 patients with nmCRPC with a PSADT of ≤10 months. Patients were randomized 2:1 to receive 600 mg NUBEQA twice daily (N=955) or placebo (N=554) concomitantly with ADT.‡ Treatment continued until radiographic disease progression (assessed by CT, MRI, 99mTc bone scan by BICR), unacceptable toxicity, or withdrawal. MFS was the primary endpoint; OS was a key secondary endpoint. MFS was statistically significant with a median of 40.4 months vs 18.4 months for placebo (HR: 0.41; 95% CI: 0.34-0.50; P<0.0001). OS was statistically significant vs placebo (HR: 0.69; 95% CI: 0.53-0.88; P=0.003).1,4,5

Rates of permanent discontinuation, dosage interruption, and dosage reduction due to AEs with NUBEQA were 9%, 13%, and 6%, respectively. Most frequent reasons for permanent discontinuation: cardiac failure (0.4%) and death (0.4%). Most frequent reasons for dosage interruption: hypertension (0.6%), diarrhea (0.5%), and pneumonia (0.5%). Most frequent reasons for dosage reduction: fatigue (0.7%), hypertension (0.3%), and nausea (0.3%).1

NCCN CLINICAL PRACTICE GUIDELINES IN ONCOLOGY (NCCN GUIDELINES®) INCLUDE MULTIPLE RECOMMENDATIONS FOR DAROLUTAMIDE (NUBEQA) ACROSS mCSPC AND nmCRPC6

NUBEQA is the fastest-growing second-generation ARI1-4,7§

*rPFS was defined as the time from randomization to radiological disease progression or death by central blinded review. Radiographic disease progression was defined by identification of 2 or more new bone lesions on a bone scan with confirmation (Prostate Cancer Working Group 3 criteria) and/or progression in soft tissue disease.1

†MFS was defined as the time from randomization to the time of first evidence of BICR-confirmed distant metastasis or death from any cause within 33 weeks after the last evaluable scan, whichever occurred first.1

‡Gonadotropin-releasing hormone agonist or antagonist or prior bilateral orchiectomy.1

§Based on prescription data claims comparing the growth for Q1 2025. Validated by IQVIA in March 2025.7

ADT=androgen deprivation therapy; AE=adverse event; ALT=alanine aminotransferase; ARI=androgen receptor inhibitor; AST=aspartate aminotransferase; BICR=blinded independent central review; CI=confidence interval; CT=computed tomography; HR=hazard ratio; mCSPC=metastatic castration-sensitive prostate cancer; MFS=metastasis-free survival; MRI=magnetic resonance imaging; NCCN=National Comprehensive Cancer Network® (NCCN®); nmCRPC=non-metastatic castration-resistant prostate cancer; OS=overall survival; PSA=prostate-specific antigen; PSADT=prostate-specific antigen doubling time; rPFS=radiographic progression-free survival.

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Indications 

NUBEQA is an androgen receptor inhibitor indicated for the treatment of adult patients with:

  • non-metastatic castration resistant prostate cancer (nmCRPC)
  • metastatic castration-sensitive prostate cancer (mCSPC)
  • metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel
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Important Safety Information

Warnings & Precautions

Ischemic Heart Disease – Ischemic heart disease, including fatal cases, occurred in patients receiving NUBEQA.

In a pooled analysis of ARAMIS and ARANOTE, ischemic heart disease occurred in 3.4% of patients receiving NUBEQA and 2.2% receiving placebo, including Grade 3-4 events in 1.4% and 0.3%, respectively. Ischemic events led to death in 0.4% of patients receiving NUBEQA and 0.4% receiving placebo.

In ARASENS, ischemic heart disease occurred in 3.2% of patients receiving NUBEQA with docetaxel and 2% receiving placebo with docetaxel, including Grade 3-4 events in 1.3% and 1.1%, respectively. Ischemic events led to death in 0.3% of patients receiving NUBEQA with docetaxel and 0% receiving placebo with docetaxel.

Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue NUBEQA for Grade 3-4 ischemic heart disease.

Seizure – Seizure occurred in patients receiving NUBEQA.

In a pooled analysis of ARAMIS and ARANOTE, Grade 1-3 seizure occurred in 0.2% of patients receiving NUBEQA. Seizure occurred from 261 to 665 days after initiation of NUBEQA.

In ARASENS, seizure occurred in 0.8% of patients receiving NUBEQA with docetaxel, including two Grade 3 events. Seizure occurred from 38 to 1754 days after initiation of NUBEQA.

It is unknown whether anti-epileptic medications will prevent seizures with NUBEQA. Advise patients of the risk of developing a seizure while receiving NUBEQA and of engaging in any activity where sudden loss of consciousness could cause harm to themselves or others. Consider discontinuation of NUBEQA in patients who develop a seizure during treatment.

Embryo-Fetal Toxicity – The safety and efficacy of NUBEQA have not been established in females. NUBEQA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment with NUBEQA and for 1 week after the last dose.

Adverse Reactions

In ARAMIS, serious adverse reactions occurred in 25% of patients receiving NUBEQA and in 20% of patients receiving placebo. Serious adverse reactions in ≥1% of patients who received NUBEQA included urinary retention, pneumonia, and hematuria. Fatal adverse reactions occurred in 3.9% of patients receiving NUBEQA and 3.2% of patients receiving placebo. Fatal adverse reactions that occurred in ≥2 patients who received NUBEQA included death (0.4%), cardiac failure (0.3%), cardiac arrest (0.2%), general physical health deterioration (0.2%), and pulmonary embolism (0.2%). The most common (>2% with a ≥2% increase compared to placebo) adverse reactions, including laboratory test abnormalities, were increased AST (23%), decreased neutrophil count (20%), fatigue (16%), increased bilirubin (16%), pain in extremity (6%), and rash (4%). Clinically relevant adverse reactions occurring in 2% or more of patients treated with NUBEQA included ischemic heart disease (4%) and heart failure (2.1%).

In ARANOTE, serious adverse reactions occurred in 24% of patients receiving NUBEQA. Serious adverse reactions in ≥1% of patients who received NUBEQA included pneumonia (2%), urinary tract infection (1.8%), musculoskeletal pain (1.6%), hemorrhage (1.6%), arrhythmias (1.3%), and spinal cord compression (1.1%). Fatal adverse reactions occurred in 4.7% of patients receiving NUBEQA and those that occurred in ≥2 patients included sepsis (1.1%), craniocerebral injury (0.4%), and myocardial infarction (0.4%). The most common (≥10% with a ≥2% increase compared to placebo) adverse reaction is urinary tract infection (12%). The most common laboratory test abnormalities (≥15% with a ≥5% increase over placebo) are increased AST (32%), increased ALT (28%), increased bilirubin (17%), and decreased neutrophil count (16%). Clinically relevant adverse reactions in <10% of patients who received NUBEQA included arrhythmia (8.8%), pneumonia (3.6%), and myocardial infarction (0.7%).

In ARASENS, serious adverse reactions occurred in 45% of patients receiving NUBEQA with docetaxel. Serious adverse reactions in ≥2% of patients who received NUBEQA with docetaxel included febrile neutropenia (6%), neutrophil count decreased (2.8%), musculoskeletal pain (2.6%) and pneumonia (2.6%). Fatal adverse reactions occurred in 4% of patients receiving NUBEQA with docetaxel. Fatal adverse reactions in ≥2 patients who received NUBEQA included COVID-19/COVID-19 pneumonia (0.8%), myocardial infarction (0.3%), and sudden death (0.3%). The most common (≥10% with a ≥2% increase over placebo with docetaxel) adverse reactions are constipation (23%), rash (20%), decreased appetite (19%), hemorrhage (18%), increased weight (18%), and hypertension (14%). The most common laboratory test abnormalities (≥30%) are anemia (72%), hyperglycemia (57%), decreased lymphocyte count (52%), decreased neutrophil count (49%), increased AST (40%), increased ALT (37%), and hypocalcemia (31%). Clinically relevant adverse reactions in <10% of patients who received NUBEQA with docetaxel included fractures (8%), ischemic heart disease (3.2%), seizures (0.6%), and drug-induced liver injury (0.3%).

Drug Interactions

Effect of Other Drugs on NUBEQA – Concomitant use of NUBEQA with a combined P-gp and strong or moderate CYP3A4 inducer decreases darolutamide exposure which may decrease NUBEQA activity. Avoid concomitant use of NUBEQA with combined P-gp and strong or moderate CYP3A4 inducers.

Concomitant use of NUBEQA with a combined P-gp and strong CYP3A4 inhibitor increases darolutamide exposure which may increase the risk of NUBEQA adverse reactions. Monitor patients more frequently for NUBEQA adverse reactions and modify NUBEQA dosage as needed.

Effects of NUBEQA on Other Drugs – NUBEQA is an inhibitor of BCRP transporter. Concomitant use of NUBEQA increases the AUC and Cmax of BCRP substrates, which may increase the risk of BCRP substrate-related toxicities. Avoid concomitant use with drugs that are BCRP substrates where possible. If used together, monitor patients more frequently for adverse reactions, and consider dose reduction of the BCRP substrate drug.

NUBEQA is an inhibitor of OATP1B1 and OATP1B3 transporters. Concomitant use of NUBEQA may increase the plasma concentrations of OATP1B1 or OATP1B3 substrates. Monitor patients more frequently for adverse reactions of these drugs and consider dose reduction while patients are taking NUBEQA.

Review the Prescribing Information of drugs that are BCRP, OATP1B1, and OATP1B3 substrates when used concomitantly with NUBEQA.

Please see the full Prescribing Information.

You are encouraged to report side effects or quality complaints of products to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

References: 1. NUBEQA (darolutamide) [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; June 2025. 2. Saad F, Vjaters E, Shore N, 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;42(36):4‌2‌7‌1‌-4‌2‌8‌1. 3. Smith MR, Hussain M, Saad F, et al; ARASENS Trial Investigators. Darolutamide and survival in metastatic, hormone-sensitive prostate cancer. N Engl J Med. 2022;386(12):1132-1142. 4. Fizazi K, Shore N, Tammela TL, et al. Darolutamide in nonmetastatic, castration-resistant prostate cancer. N Engl J Med. 2019;380(13):1235-1246. 5. Fizazi K, Shore N, Tammela TL, et al. Nonmetastatic, castration-resistant prostate cancer and survival with darolutamide. N Engl J Med. 2020;383(11):1040-1049. 6. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.2.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed April 22, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way. 7. Data on file. Bayer IQVIA NPA. Bayer HealthCare Pharmaceuticals, Inc.; Whippany, NJ.

© 2019 Bayer AG

Last updated on 29/06/2021

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