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When treating non-metastatic castration-resistant prostate cancer (nmCRPC),

METASTASIS-FREE SURVIVAL (MFS) IS

JUST THE HALF OF IT

NUBEQA®—focus on both MFS* and tolerability.1,2

*Metastasis-free survival is defined as the time from randomization to the time of first evidence of blinded independent central review–confirmed distant metastasis or death from any cause within 33 weeks after the last evaluable scan, whichever occurred first.

When treating non-metastatic castration-resistant prostate cancer (nmCRPC),

METASTASIS-FREE SURVIVAL (MFS) IS

JUST THE HALF OF IT

NUBEQA®—focus on both MFS* and tolerability.1,2

*Metastasis-free survival is defined as the time from randomization to the time of first evidence of blinded independent central review–confirmed distant metastasis or death from any cause within 33 weeks after the last evaluable scan, whichever occurred first.

*Metastasis-free survival is defined as the time from randomization to the time of first evidence of blinded independent central review–confirmed distant metastasis or death from any cause within 33 weeks after the last evaluable scan, whichever occurred first.

INDICATION

NUBEQA® (darolutamide) is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer.

EXTENDED MFS AND TOLERABILITY
for men with nmCRPC1,2

Efficacy

40
months

More than double the median MFS with NUBEQA + ADT* vs 18 months with ADT alone†‡

PROVEN TOLERABILITY

Proven
tolerability

Three adverse reactions occurred more frequently with NUBEQA + ADT (≥2% over ADT alone): fatigue (16% vs 11%), pain in extremity (6% vs 3%), and rash (3% vs 1%)§

SAME RATE OF PERMANENT DISCONTINUATION

Same rate of
permanent discontinuation

9% of men permanently discontinued due to adverse reactions whether on NUBEQA + ADT or ADT alone||

Dose interruptions and reductions due to adverse reactions occurred in 13% and 6%, respectively, of patients treated with NUBEQA + ADT

*95% CI: 34.3-NR.

95% CI: 15.5-22.3.

HR: 0.41; 95% CI: 0.34-0.50; P<0.0001.

§Overall, serious adverse reactions occurred in 25% of men receiving NUBEQA + ADT and in 20% of men receiving ADT alone. Serious adverse reactions in ≥1% of men who received NUBEQA + ADT included urinary retention, pneumonia, and hematuria.

Additionally, clinically significant adverse reactions occurring in ≥2% of men treated with NUBEQA + ADT vs ADT alone included ischemic heart disease (4.0% vs 3.4%) and heart failure (2.1% vs 0.9%).

All-grade laboratory abnormalities in patients treated with NUBEQA + ADT vs ADT alone were, respectively, decreased neutrophil count (20% vs 9%), increased AST (23% vs 14%), and increased bilirubin (16% vs 7%). Grade 3-4 for same lab abnormalities were, respectively, 4% vs 0.6%, 0.5% vs 0.2%, and 0.1% vs 0%.

||The most frequent adverse reactions requiring permanent discontinuation in patients treated with NUBEQA + ADT included cardiac failure (0.4%) and death (0.4%).

In patients treated with NUBEQA + ADT, the most frequent adverse reactions requiring dose interruption included hypertension (0.6%), diarrhea (0.5%), and pneumonia (0.5%); the most frequent adverse reactions requiring dose reduction included fatigue (0.7%), hypertension (0.3%), and nausea (0.3%).

 

The efficacy and safety of NUBEQA were assessed in a randomized, double-blind, placebo-controlled, international, multicenter phase III study (ARAMIS) in nmCRPC patients with a prostate-specific antigen doubling time of ≤10 months. 1509 patients were randomized 2:1 to receive either 600 mg NUBEQA twice daily (n=955) or matching placebo (n=554). All patients received concurrent ADT (treatment with GnRH analog or previous bilateral orchiectomy). The primary endpoint was MFS. Treatment continued until radiographic disease progression, as assessed by CT, MRI, 99mTc bone scan by BICR, unacceptable toxicity, or withdrawal. OS data were not mature at the time of final MFS analysis (57% of the required number of events).1,2 The planned final OS analysis has been conducted and mature data on OS will be presented at an upcoming scientific meeting.

ADT=androgen deprivation therapy; CI=confidence interval; NR=not reached; HR=hazard ratio; GnRH=gonadotropin-releasing hormone; BICR=blinded independent central review; CT=computed tomography; MRI=magnetic resonance imaging; OS=overall survival; AST=aspartate transaminase.

MEN IN YOUR PRACTICE MAY BENEFIT
from NUBEQA

MEN IN YOUR PRACTICE MAY BENEFIT FROM NUBEQA (darolutamide)
  • Prostate cancer has not yet metastasized
  • Rising PSA despite treatment with ADT

DUDE ACCESS SERVICES™
is ready to support you and your patients

DUDE Access Services, Darolutamide User Drug Experience

833-337-DUDE (3833)

MONDAY – FRIDAY:

9:00 AM – 7:00 PM (EST)

INDIKATION

NUBEQA®, (in Kombination mit einer Androgendeprivationstherapie (ADT), ist indiziert für die Behandlung von erwachsenen Patienten mit nicht-metastasiertem, kastrationsresistentem Prostatakarzinom (NM-CRPC), bei denen ein hohes Risiko für eine Entwicklung von Metastasen besteht (insbesondere PSADT 10 Monate)1

 

Wichtige Informationen zu Risiken und Anwendung von NUBEQA® finden Sie in der vollständigen Fachinformation.

Bitte melden Sie Nebenwirkungen an:

drug.safety.switzerland@bayer.ch oder
Tel. +41 44 465 8200


oder Beschwerden über die Produktqualität an:
quality.switzerland@bayer.com oder
Tel:. +41 44 465 8310

References:

  • NUBEQA (darolutamide) [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc.; July 2019. Return to content
  • Fizazi K, Shore N, Tammela TL, et al. Darolutamide in nonmetastatic, castration-resistant prostate cancer. N Engl J Med. 2019;380(13):1235-1246. Return to content
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When treating non-metastatic castration-resistant prostate cancer (nmCRPC),

METASTASIS-FREE SURVIVAL (MFS) IS

JUST THE HALF OF IT

NUBEQA®—focus on both MFS* and tolerability.1,2

*Metastasis-free survival is defined as the time from randomization to the time of first evidence of blinded independent central review–confirmed distant metastasis or death from any cause within 33 weeks after the last evaluable scan, whichever occurred first.

When treating non-metastatic castration-resistant prostate cancer (nmCRPC),

METASTASIS-FREE SURVIVAL (MFS) IS

JUST THE HALF OF IT

NUBEQA®—focus on both MFS* and tolerability.1,2

*Metastasis-free survival is defined as the time from randomization to the time of first evidence of blinded independent central review–confirmed distant metastasis or death from any cause within 33 weeks after the last evaluable scan, whichever occurred first.

*Metastasis-free survival is defined as the time from randomization to the time of first evidence of blinded independent central review–confirmed distant metastasis or death from any cause within 33 weeks after the last evaluable scan, whichever occurred first.

INDICATION

NUBEQA® (darolutamide) is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer.

EXTENDED MFS AND TOLERABILITY
for men with nmCRPC1,2

Efficacy

40
months

More than double the median MFS with NUBEQA + ADT* vs 18 months with ADT alone†‡

PROVEN TOLERABILITY

Proven
tolerability

Three adverse reactions occurred more frequently with NUBEQA + ADT (≥2% over ADT alone): fatigue (16% vs 11%), pain in extremity (6% vs 3%), and rash (3% vs 1%)§

SAME RATE OF PERMANENT DISCONTINUATION

Same rate of
permanent discontinuation

9% of men permanently discontinued due to adverse reactions whether on NUBEQA + ADT or ADT alone||

Dose interruptions and reductions due to adverse reactions occurred in 13% and 6%, respectively, of patients treated with NUBEQA + ADT

*95% CI: 34.3-NR.

95% CI: 15.5-22.3.

HR: 0.41; 95% CI: 0.34-0.50; P<0.0001.

§Overall, serious adverse reactions occurred in 25% of men receiving NUBEQA + ADT and in 20% of men receiving ADT alone. Serious adverse reactions in ≥1% of men who received NUBEQA + ADT included urinary retention, pneumonia, and hematuria.

Additionally, clinically significant adverse reactions occurring in ≥2% of men treated with NUBEQA + ADT vs ADT alone included ischemic heart disease (4.0% vs 3.4%) and heart failure (2.1% vs 0.9%).

All-grade laboratory abnormalities in patients treated with NUBEQA + ADT vs ADT alone were, respectively, decreased neutrophil count (20% vs 9%), increased AST (23% vs 14%), and increased bilirubin (16% vs 7%). Grade 3-4 for same lab abnormalities were, respectively, 4% vs 0.6%, 0.5% vs 0.2%, and 0.1% vs 0%.

||The most frequent adverse reactions requiring permanent discontinuation in patients treated with NUBEQA + ADT included cardiac failure (0.4%) and death (0.4%).

In patients treated with NUBEQA + ADT, the most frequent adverse reactions requiring dose interruption included hypertension (0.6%), diarrhea (0.5%), and pneumonia (0.5%); the most frequent adverse reactions requiring dose reduction included fatigue (0.7%), hypertension (0.3%), and nausea (0.3%).

 

The efficacy and safety of NUBEQA were assessed in a randomized, double-blind, placebo-controlled, international, multicenter phase III study (ARAMIS) in nmCRPC patients with a prostate-specific antigen doubling time of ≤10 months. 1509 patients were randomized 2:1 to receive either 600 mg NUBEQA twice daily (n=955) or matching placebo (n=554). All patients received concurrent ADT (treatment with GnRH analog or previous bilateral orchiectomy). The primary endpoint was MFS. Treatment continued until radiographic disease progression, as assessed by CT, MRI, 99mTc bone scan by BICR, unacceptable toxicity, or withdrawal. OS data were not mature at the time of final MFS analysis (57% of the required number of events).1,2 The planned final OS analysis has been conducted and mature data on OS will be presented at an upcoming scientific meeting.

ADT=androgen deprivation therapy; CI=confidence interval; NR=not reached; HR=hazard ratio; GnRH=gonadotropin-releasing hormone; BICR=blinded independent central review; CT=computed tomography; MRI=magnetic resonance imaging; OS=overall survival; AST=aspartate transaminase.

MEN IN YOUR PRACTICE MAY BENEFIT
from NUBEQA

MEN IN YOUR PRACTICE MAY BENEFIT FROM NUBEQA (darolutamide)
  • Prostate cancer has not yet metastasized
  • Rising PSA despite treatment with ADT

DUDE ACCESS SERVICES™
is ready to support you and your patients

DUDE Access Services, Darolutamide User Drug Experience

833-337-DUDE (3833)

MONDAY – FRIDAY:

9:00 AM – 7:00 PM (EST)

INDIKATION

NUBEQA®, (in Kombination mit einer Androgendeprivationstherapie (ADT), ist indiziert für die Behandlung von erwachsenen Patienten mit nicht-metastasiertem, kastrationsresistentem Prostatakarzinom (NM-CRPC), bei denen ein hohes Risiko für eine Entwicklung von Metastasen besteht (insbesondere PSADT 10 Monate)1

 

Wichtige Informationen zu Risiken und Anwendung von NUBEQA® finden Sie in der vollständigen Fachinformation.

Bitte melden Sie Nebenwirkungen an:

drug.safety.switzerland@bayer.ch oder
Tel. +41 44 465 8200


oder Beschwerden über die Produktqualität an:
quality.switzerland@bayer.com oder
Tel:. +41 44 465 8310

References:

  • NUBEQA (darolutamide) [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc.; July 2019. Return to content
  • Fizazi K, Shore N, Tammela TL, et al. Darolutamide in nonmetastatic, castration-resistant prostate cancer. N Engl J Med. 2019;380(13):1235-1246. Return to content