EU Approval Sought for Darolutamide Plus ADT for mHSPC

EU Approval Sought for Darolutamide Plus ADT for mHSPC - OncLive

The EMA has received a submission seeking the approval of darolutamide in combination with ADT in metastatic hormone-sensitive prostate ...

EU approval sought for darolutamide plus ADT in mHSPC

Darolutamide plus ADT significantly improved rPFS and OS in mHSPC patients compared to placebo, with a 46% risk reduction in radiological ...

Bayer submits application for third indication of darolutamide in the EU

... 46% compared to placebo plus ADT in patients with metastatic hormone-sensitive prostate cancer (mHSPC) / Darolutamide plus ...

OncLive.com on X: "The EMA has received a submission seeking ...

... seeking the approval of darolutamide in combination with ADT in ... EU Approval Sought for Darolutamide Plus ADT for mHSPC. The EMA has ...

FDA and EMA Approval Sought for Darolutamide Plus Docetaxel in ...

“Prostate cancer is a key area of focus at Bayer and the US and European submissions for [darolutamide] in mHSPC represent a significant ...

Nubeqa™ (darolutamide) receives EU approval for additional ...

The EU approval is based on the positive results from the Phase III ARASENS trial, which demonstrated that darolutamide plus ADT in combination ...

Bayer Seeks European Approval For Third Indication For Cancer ...

Bayer has submitted an EMA application for darolutamide combined with ADT for metastatic hormone-sensitive prostate cancer. · The Phase 3 ARANOTE ...

Urology Times on X: "Bayer has submitted an application to the ...

... seeking approval of darolutamide in combination with ADT for mHSPC. # ... EU approval sought for darolutamide plus ADT in mHSPC. The ...

Darolutamide Plus Androgen-Deprivation Therapy and Docetaxel in ...

In patients with metastatic hormone-sensitive prostate cancer, early treatment intensification with a combination of androgen-deprivation therapy (ADT) plus ...

Bayer Submits Applications in the U.S. and EU for Additional ... - News

Bayer is seeking approval for the use of NUBEQA in combination ... plus androgen deprivation therapy (ADT) and docetaxel in men with mHSPC.

Darolutamide receives EU approval for additional indication in ...

The European Commission has granted marketing authorisation in the European Union for darolutamide, an oral androgen receptor inhibitor, plus androgen ...

Darolutamide in Addition to Standard Androgen Deprivation ...

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 ...

Darolutamide in Combination With Androgen-Deprivation Therapy ...

Darolutamide plus androgen-deprivation therapy (ADT) with docetaxel improved OS versus ADT and docetaxel in patients with mHSPC. The ARANOTE trial evaluated ...

sNDA Filed With FDA for Darolutamide Plus ADT in mHSPC

A supplemental new drug application seeking expanded indication for darolutamide combined with androgen deprivation therapy for the ...

Thompson: 'It's time for a national solution' - Urology Times

Key Takeaways · EU approval sought for darolutamide plus ADT in mHSPC · Phase 3 trial of 64Cu-SAR-bisPSMA in BCR of prostate cancer set to launch in 2025.

Darolutamide: A Review in Metastatic Hormone-Sensitive Prostate ...

Darolutamide (NUBEQA®) is an orally administered ARi which has been approved in combination with ADT and docetaxel for the treatment of mHSPC.

Darolutamide receives EU approval for additional indication

The EU approval is based on the positive results from the Phase III ARASENS trial, which demonstrated that darolutamide plus ADT in combination ...

Approval Sought for Darolutamide With Docetaxel for Metastatic ...

Bayer has filed a supplemental new drug application (sNDA) to the FDA for the approval of darolutamide (Nubeqa) plus docetaxel in patients ...

FDA Approval Sought for Darolutamide/Docetaxel for Metastatic ...

“Prostate cancer is a key area of focus at Bayer and the United States and European Union submissions for Nubeqa in mHSPC represent a ...

Darolutamide receives EU approval for additional indication in ...

European Commission granted approval of darolutamide for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) · Approval is based ...