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 ongoingApproval was based on the P-III (ARANOTE) trial evaluating Nubeqa (600mg, BID) + ADT (n=446) vs PBO + ADT (n=223) in 669 mHSPC ptsTrial showed a 46% reduction in rPFS (1EP),…

ByRidhi RastogiJune 4, 2025

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Bayer Reports Post-Hoc Data from P-III (ARANOTE) Trial of Nubeqa to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots:Bayer has reported post-hoc analyses from P-III (ARANOTE) trial assessing Nubeqa (darolutamide; 600mg, BID) + androgen deprivation therapy (ADT) (n=446) vs PBO + ADT (n=223) in mHSPC pts (N=669)Post-hoc analyses showed that 42.6% pts achieved ultra-low PSA levels (<0.02ng/mL) vs 7.8% pts on PBO & this response was associated with prolonged rPFS, delayed…

ByRidhi RastogiApril 30, 2025

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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

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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 industryIn 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 diseasePharmaShots has compiled a…

BySenior EditorApril 27, 2023

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

Bayer Reports Post-Hoc Data from P-III (ARANOTE) Trial of Nubeqa to Treat 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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Bayer Reports the US FDA’s Approval of Nubeqa for Treating Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Bayer Reports Post-Hoc Data from P-III (ARANOTE) Trial of Nubeqa to Treat 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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