Johnson & Johnson Reports the US FDA Approval of Akeega to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots: The US FDA has approved J&J's Akeega (niraparib & abiraterone acetate tablet) + prednisone to treat adults with BRCA2-mutated mHSPC Approval was backed by the ongoing P-III (AMPLITUDE) trial assessing Akeega + prednisone/prednisolone + ADT vs PBO/abiraterone acetate with prednisone + ADT in 696 pts with deleterious germline or somatic HRR gene-altered mHSPC Trial met its…

ByRidhi RastogiDecember 15, 2025

NEWS

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

Shots: Health Canada 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 RastogiAugust 22, 2025

NEWS

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

Johnson & Johnson Reports the US FDA Approval of Akeega to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

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

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

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