Docetaxel Articles & Analysis: Older
17 news found
” The approval is based on the positive results from the Phase III ARASENS trial, which demonstrated that darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel significantly reduced the risk of death by 32.5% compared to ADT with docetaxel, in patients with metastatic hormone-sensitive prostate cancer (mHSPC). ...
ByBayer AG
” The EU approval is based on the positive results from the Phase III ARASENS trial, which demonstrated that darolutamide plus ADT in combination with docetaxel significantly reduced the risk of death by 32.5% compared to ADT with docetaxel, in patients with mHSPC. ...
ByBayer AG
Darolutamide approved for metastatic prostate cancer as well as non-metastatic castration-resistant prostate cancer New approval based on data from the pivotal Phase III ARASENS trial 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 ...
ByBayer AG
New subgroup analysis from Phase III ARASENS trial shows that darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel increased overall survival (OS) and improved key clinically relevant endpoints in patients with various types of metastatic disease burden and risk, compared to ADT with docetaxel alone Favorable safety profile of ...
ByBayer AG
CHMP recommendation is based on Phase III data, which demonstrated that darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel significantly reduced the risk of death by 32.5% compared to ADT with docetaxel alone, with similar overall rates of adverse events between study arms European Commission decision on granting a marketing ...
ByBayer AG
Development programs include Cantrixil, in clinical development for late-stage ovarian cancer, and docetaxel micellar, in development for advanced prostate cancer. Vivesto has proprietary drug delivery technology designed to improve solubility, efficacy and safety. ...
Development programs include Cantrixil, in clinical development for late-stage ovarian cancer, and docetaxel micellar, in development for advanced prostate cancer. Vivesto has proprietary drug delivery technology designed to improve solubility, efficacy and safety. ...
Development programs include Cantrixil, in clinical development for late-stage ovarian cancer, and docetaxel micellar, in development for advanced prostate cancer. Vivesto has proprietary drug delivery technology designed to improve solubility, efficacy and safety. ...
” Additionally, treatment with darolutamide plus ADT and docetaxel showed a trend toward delaying time to worsening of disease-related physical symptoms and pain in patients with moderate or severe baseline pain and improvement across patient-relevant endpoints compared to ADT plus docetaxel, supporting early treatment intensification with addition of ...
ByBayer AG
Darolutamide now has indications in both non-metastatic castration-resistant prostate cancer (nmCRPC) for men at high risk of developing metastatic disease and metastatic hormone-sensitive prostate cancer (mHSPC) Today’s approval under the FDA’s Real-Time Oncology Review (RTOR) pilot program was based on the pivotal Phase III ARASENS trial, which showed a significant overall ...
ByBayer AG
Development programs include Cantrixil, in clinical development for late-stage ovarian cancer, and docetaxel micellar, in development for advanced prostate cancer. Vivesto has proprietary drug delivery technology designed to improve solubility, efficacy and safety. ...
Development programs include Cantrixil, in clinical development for late-stage ovarian cancer, and docetaxel micellar, in development for advanced prostate cancer. Vivesto has proprietary drug delivery technology designed to improve solubility, efficacy and safety. ...
“Today’s sNDA acceptance, confirmation of Priority Review and participation in Project Orbis, bring us closer to adding a new indication for darolutamide in combination with docetaxel to benefit men with mHSPC.” The sNDA is based on positive results from the pivotal Phase III ARASENS trial demonstrating a statistically significant improvement in overall ...
ByBayer AG
Darolutamide 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 2022 ASCO GU Cancers Symposium and simultaneously published in The New England Journal of Medicine. ...
ByBayer AG
Raise in peak sales expectations follows presentation of positive Phase III trial ARASENS with darolutamide (Nubeqa) in metastatic hormone-sensitive prostate cancer at 2022 ASCO GU Cancers Symposium and publication in The New England Journal of Medicine on February 17, 2022 Broad development program underway with three additional ongoing or planned large clinical studies for darolutamide ...
ByBayer AG
Delta, Canada, January 4, 2022 — Phyton Biotech, Ltd., a global leader in specialty fermentation solutions for naturally derived compounds and the largest global supplier of Paclitaxel and Docetaxel via Plant Cell Fermentation® (PCF), is pleased to announce the appointment of Stephen Ball as the Company’s new VP of Business Development, Strategic Growth. ...
In the ARASENS trial, darolutamide in combination with docetaxel and androgen deprivation therapy (ADT) significantly increased overall survival (OS) compared to docetaxel and ADT. ...
ByBayer AG