Bayer Reports EC’s Approval of Nubeqa for Treating Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots: The EC has approved Nubeqa (darolutamide) in combination with androgen deprivation therapy (ADT) ± docetaxel to treat mHSPC pts Approval was based on the P-III (ARANOTE) trial evaluating Nubeqa (600mg, BID) + ADT vs PBO + ADT in 669 mHSPC pts Trial showed a 46% reduction in rPFS (1EP), with consistent benefit observed across all subgroups, incl. pts…

ByRidhi RastogiJuly 21, 2025

NEWS

Bayer Reports the US FDA’s Approval of Nubeqa for Treating Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots: The US FDA has approved Nubeqa (darolutamide) in combination with androgen deprivation therapy (ADT) ± docetaxel to treat mHSPC pts; approval process in the EU is ongoing Approval was based on the P-III (ARANOTE) trial evaluating Nubeqa (600mg, BID) + ADT (n=446) vs PBO + ADT (n=223) in 669 mHSPC pts Trial showed a 46% reduction in rPFS (1EP),…

ByRidhi RastogiJune 4, 2025

VIEWPOINTS

Bayer at ASCO GU: Neal Shore Speaking about Nubeqa with PharmaShots

Shots: At ASCO GU, Bayer presented new data from its Oncology portfolio. The analysis revolved around NUBEQA (darolutamide), which is currently approved in the US in combination with docetaxel for the treatment of mHSPC and nmCRPC in adults Neal Shore in conversation with PharmaShots initiated the discussion by familiarizing our audience with the ARASENS P-III…

BySaurabh ChaubeyApril 10, 2024

INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in March 2023

Shots: The EMA approved 4 New Chemical Entity (NCE) and 5 Biologic Drugs in March 2023, leading to treatments for patients and advances in the healthcare industry In March 2023, the major highlights drugs were Reblozyl’s Approval for anemia in adult patients with non-transfusion-dependent beta thalassemia, Pombiliti for late-onset pompe disease PharmaShots has compiled a…

BySenior EditorApril 27, 2023

Bayer Reports EC’s Approval of Nubeqa for Treating Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Bayer Reports the US FDA’s Approval of Nubeqa for Treating Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Bayer at ASCO GU: Neal Shore Speaking about Nubeqa with PharmaShots

Insights+: EMA Marketing Authorization of New Drugs in March 2023

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