METASTATIC HORMONE-SENSITIVE PROSTATE CANCER


Associated tags: Survival, Cancer, Prostate cancer, Radiation, Disease, Diagnosis, ADT, Malignancy, Patient, Pharmaceutical industry, Docetaxel, Bayer, Death, Oncology, Ari, Health, Pharmaceutical, Biotechnology, Phase, Science, Research, Darolutamide, Orion, Incidence, Clinical Trials

Darolutamide approved for additional prostate cancer indication in China

Retrieved on: 
Monday, March 20, 2023
Docetaxel, The New England Journal of Medicine, Prostate cancer, Orion, University of Medicine 1, Yangon, ADT, Darolutamide, Incidence, Patient, Risk, Ari, Phase, Death, NMPA, Disease, Pharmaceutical industry, Bayer

The Chinese National Medical Products Administration (NMPA) has approved the oral androgen receptor inhibitor (ARi) darolutamide in combination with docetaxel for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).

Key Points: 
  • The Chinese National Medical Products Administration (NMPA) has approved the oral androgen receptor inhibitor (ARi) darolutamide in combination with docetaxel for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).
  • Darolutamide is already approved in China for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease.
  • Additionally, the darolutamide combination showed consistent benefits across clinically relevant secondary endpoints, with the overall incidence of treatment-emergent adverse events being similar between treatment arms.
  • This includes the ARANOTE Phase III trial evaluating darolutamide plus androgen deprivation therapy (ADT) versus ADT alone for mHSPC.

Darolutamide receives EU approval for additional indication in prostate cancer

Retrieved on: 
Wednesday, March 1, 2023
Death, Prostate cancer, European, European Commission, Co-promotion, Disease, Ari, Risk, Darolutamide, Patient, ADT, Orion, Docetaxel, Incidence, Phase, Pharmaceutical industry, Bayer, EU

The European Commission has granted marketing authorisation in the European Union (EU) for darolutamide, an oral androgen receptor inhibitor (ARi), plus androgen deprivation therapy (ADT) in combination with docetaxel, for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).

Key Points: 
  • The European Commission has granted marketing authorisation in the European Union (EU) for darolutamide, an oral androgen receptor inhibitor (ARi), plus androgen deprivation therapy (ADT) in combination with docetaxel, for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).
  • Darolutamide is already approved under the brand name Nubeqa® for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease.
  • Additionally, the darolutamide combination showed consistent benefits across clinically relevant secondary endpoints, with the overall incidence of treatment-emergent adverse events being similar between treatment arms.
  • Darolutamide is being investigated in a broad development program with an additional three ongoing or planned large clinical studies, to investigate its potential across prostate cancer patients from the early- to the late-stage of this disease.

Darolutamide receives approval for additional prostate cancer indication in Japan

Retrieved on: 
Monday, February 27, 2023
CHMP, Death, Ministry of Health (Kuwait), Ministry, Prostate cancer, The New England Journal of Medicine, Disease, Ari, Risk, Darolutamide, Patient, ADT, Orion, Docetaxel, University of Medicine 1, Yangon, Indoor Living, European Directive on Traditional Herbal Medicinal Products, Incidence, Phase, MHLW, Pharmaceutical industry, Health, Bayer, EU

The Ministry of Health, Labor and Welfare (MHLW) in Japan has approved the oral androgen receptor inhibitor (ARi) darolutamide plus ADT in combination with docetaxel in the indication of metastatic prostate cancer.

Key Points: 
  • The Ministry of Health, Labor and Welfare (MHLW) in Japan has approved the oral androgen receptor inhibitor (ARi) darolutamide plus ADT in combination with docetaxel in the indication of metastatic prostate cancer.
  • Additionally, the darolutamide combination showed consistent benefits across clinically relevant secondary endpoints, with the overall incidence of treatment-emergent adverse events being similar between treatment arms.
  • Darolutamide is being investigated in a broad development program with three additional ongoing or planned large clinical studies, to evauate its potential across prostate cancer patients from the early- to the late-stage of this disease.
  • This includes the ARANOTE Phase III trial evaluating darolutamide plus androgen deprivation therapy (ADT) versus ADT alone for mHSPC.

New NUBEQA® (darolutamide) Subgroup Analyses from the Phase III ARASENS Trial in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Patients Presented at ASCO GU

Retrieved on: 
Thursday, February 16, 2023
Research, Clinical Trials, Health Technology, Health Insurance, Biotechnology, Pharmaceutical, Health, Science, Oncology, Other Science, ADT, Death, Risk, Journal, Docetaxel, ASCO, Patient, Medical imaging, Pharmaceutical industry

Subgroup analyses from the pivotal Phase III ARASENS trial support overall survival (OS) benefits of NUBEQA® (darolutamide) plus androgen deprivation therapy (ADT) and docetaxel compared to ADT and docetaxel in patients with high-volume and high and low-risk metastatic hormone-sensitive prostate cancer (mHSPC).

Key Points: 
  • Subgroup analyses from the pivotal Phase III ARASENS trial support overall survival (OS) benefits of NUBEQA® (darolutamide) plus androgen deprivation therapy (ADT) and docetaxel compared to ADT and docetaxel in patients with high-volume and high and low-risk metastatic hormone-sensitive prostate cancer (mHSPC).
  • “The growing analyses from the ARASENS trial continue to demonstrate NUBEQA’s value in treating patients with mHSPC.
  • “An important part of our mission at Bayer is prostate cancer care and improving patient outcomes at different stages of the disease.
  • A consistent OS benefit was observed in both high-risk (HR=0.71; 95% CI 0.58-0.86; n=912) and low-risk (HR=0.62; 95% CI 0.42-0.90; n=393) disease.

Merck Announces KEYNOTE-991 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus Enzalutamide and Androgen Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer to Stop for Futility

Retrieved on: 
Wednesday, January 25, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, MSD, Prostate, Data monitoring committee, NYSE, Patient, Incidence, Merck & Co., Prostate cancer, RPF, Disease, ADT, MRK, Orion Corporation, Pharmaceutical industry, Merck

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that it will stop the Phase 3 KEYNOTE-991 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with enzalutamide and androgen deprivation therapy (ADT) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).

Key Points: 
  • Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that it will stop the Phase 3 KEYNOTE-991 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with enzalutamide and androgen deprivation therapy (ADT) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).
  • Merck is discontinuing the study based on the recommendation of an independent Data Monitoring Committee which reviewed data from a planned interim analysis.
  • The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies.
  • Merck is informing study investigators of the decision and advises patients in the study to speak to their physician regarding treatment.

Positive CHMP opinion for darolutamide in combination with docetaxel for the treatment of metastatic hormone-sensitive prostate cancer

Retrieved on: 
Friday, January 27, 2023
Marketing, Royal commission, Disease, European Directive on Traditional Herbal Medicinal Products, Prostate cancer, Docetaxel, ADT, European Commission, Risk, European Medicines Agency, Trial master file, Phase, Ari, Patient, Union, Co-promotion, Orion, Committee, EMA, Death, Committee for Medicinal Products for Human Use, AES, Darolutamide, Pharmaceutical industry, EU, CHMP, Bayer

Darolutamide is already approved under the brand name Nubeqa® for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease.

Key Points: 
  • Darolutamide is already approved under the brand name Nubeqa® for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease.
  • The final decision from the European Commission on the marketing authorisation is expected in the coming months.
  • This includes the ARANOTE Phase III trial evaluating darolutamide plus androgen deprivation therapy (ADT) versus ADT alone for mHSPC.
  • Bayer is responsible for global commercialisation, with co-promotion from Bayer and Orion in certain European markets, e.g.

U.S. FDA Approves Additional Indication of NUBEQA® (darolutamide) in Combination with Docetaxel for the Treatment of Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Retrieved on: 
Saturday, August 6, 2022
Research, FDA, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, FDA, Death, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Phase, Ari, Risk, Docetaxel, New Drug Application, Bayer, Food, Patient, Adult, ADT, Shanda, Pharmaceutical industry

Serious adverse reactions occurred in 45% of patients receiving NUBEQA with docetaxel and in 42% of patients receiving placebo with docetaxel.

Key Points: 
  • Serious adverse reactions occurred in 45% of patients receiving NUBEQA with docetaxel and in 42% of patients receiving placebo with docetaxel.
  • Permanent discontinuation of NUBEQA due to adverse reactions occurred in 14% of patients treated in the NUBEQA with docetaxel arm.
  • Dosage interruptions of NUBEQA due to adverse reactions occurred in 23% of patients treated in the NUBEQA with docetaxel arm.
  • Dosage reductions of NUBEQA due to adverse reactions occurred in 9% of patients treated in the NUBEQA with docetaxel arm.

U.S. FDA Accepts Supplemental New Drug Application (sNDA) and Grants Priority Review for NUBEQA® (darolutamide) in Combination with Docetaxel for Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Retrieved on: 
Tuesday, May 3, 2022
Biotechnology, FDA, Health, Other Health, Pharmaceutical, Other Science, Research, Medical Devices, Managed Care, General Health, Fitness & Nutrition, Science, Clinical Trials, Medical Supplies

Bayer today announced the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for the oral androgen receptor inhibitor (ARi) NUBEQA (darolutamide) in combination with docetaxel for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC).

Key Points: 
  • Bayer today announced the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for the oral androgen receptor inhibitor (ARi) NUBEQA (darolutamide) in combination with docetaxel for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC).
  • NUBEQA (darolutamide) is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer.
  • Effect of Other Drugs on NUBEQA Combined P-gp and strong or moderate CYP3A4 inducers decrease NUBEQA exposure, which may decrease NUBEQA activity.
  • Ng, K., Smith, S., Shamash, J. Metastatic Hormone-Sensitive Prostate Cancer (mHSPC): Advances and Treatment Strategies in the First-Line Setting.

Bayer Submits Applications in the U.S. and EU for Additional Indication of NUBEQA® (darolutamide)

Retrieved on: 
Wednesday, March 9, 2022
Oncology, Health, FDA, Research, Science, Pharmaceutical, Biotechnology, the ARASENS Trial2, NUBEQA® (darolutamide)3, Metastatic Hormone-Sensitive Prostate Cancer, Oncology at Bayer, Bayer, THE ARASENS TRIAL2, NUBEQA® (DAROLUTAMIDE)3, METASTATIC HORMONE-SENSITIVE PROSTATE CANCER, ONCOLOGY AT BAYER, BAYER

Bayer is seeking approval for the use of NUBEQA in combination with docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC).

Key Points: 
  • Bayer is seeking approval for the use of NUBEQA in combination with docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC).
  • NUBEQA (darolutamide) is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer.
  • Effect of Other Drugs on NUBEQA Combined P-gp and strong or moderate CYP3A4 inducers decrease NUBEQA exposure, which may decrease NUBEQA activity.
  • BAYER, the Bayer Cross and NUBEQA are registered trademarks of Bayer.

Positive Results from Phase III Investigational Trial Shows NUBEQA® (darolutamide) Plus Androgen Deprivation Therapy (ADT) and Docetaxel Significantly Increases Overall Survival (OS) in Patients with mHSPC

Retrieved on: 
Thursday, February 17, 2022
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Patient, Death, Docetaxel, ADT, Risk, Ari, Pharmaceutical industry, Birth control, the ARASENS Trial2, NUBEQA® (darolutamide)3, Metastatic Hormone-Sensitive Prostate Cancer, Oncology at Bayer, Bayer, THE ARASENS TRIAL2, NUBEQA® (DAROLUTAMIDE)3, METASTATIC HORMONE-SENSITIVE PROSTATE CANCER, ONCOLOGY AT BAYER, BAYER

Results from the investigational Phase III ARASENS trial have shown that the use of oral androgen receptor inhibitor (ARi) NUBEQA (darolutamide) plus androgen deprivation therapy (ADT) and docetaxel significantly increased overall survival (OS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) compared to ADT plus docetaxel.

Key Points: 
  • Results from the investigational Phase III ARASENS trial have shown that the use of oral androgen receptor inhibitor (ARi) NUBEQA (darolutamide) plus androgen deprivation therapy (ADT) and docetaxel significantly increased overall survival (OS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) compared to ADT plus docetaxel.
  • NUBEQA plus ADT and docetaxel significantly reduced the risk of death by 32.5% compared to ADT plus docetaxel (HR=0.68, 95% CI 0.57-0.80; P
  • ARASENS demonstrated that the addition of NUBEQA, an androgen receptor inhibitor, significantly increased overall survival for patients receiving standard androgen deprivation therapy and docetaxel as initial treatment for metastatic hormone-sensitive prostate cancer.
  • NUBEQA (darolutamide) is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer.