Bayer’s NUBEQA combo shows 71% drop in risk of progression or death in prostate cancer trial

Despite the strong results, investigators cautioned that the study has limitations, including its open-label Phase II design, lack of randomization, and reliance on a historical external control arm

FDA advisory panel backs AstraZeneca prostate cancer combo in decisive vote

The Committee backed the combination based on results from the CAPItello-281 Phase III trial, marking a key milestone in the regulatory pathway for AstraZeneca’s targeted therapy strategy in prostate cancer

China nod to Darolutamide for metastatic hormone-sensitive prostate cancer

The approval follows the pivotal Phase III ARANOTE trial, which demonstrated that darolutamide plus ADT cut the risk of radiological progression or death by 46% compared to placebo plus ADT

FDA nod to Johnson & Johnson’s AKEEGA for aggressive prostate cancer

Patients with BRCA mutations often face aggressive disease and poor prognosis

Biocon Biologics secures US market entry date for Bosaya and Aukelso, Denosumab biosimilars

Biocon Biologics receives FDA approval for Bosaya and Aukelso biosimilars

Bayer’s Nubeqa receives EU approval for patients with advanced prostate cancer

European Commission granted approval of darolutamide in combination with androgen deprivation therapy (ADT) for patients with metastatic hormone-sensitive prostate cancer (mHSPC)

Astellas and Pfizer’s XTANDI shows overall survival in metastatic hormone-sensitive prostate cancer

Five-year follow-up data from the Phase 3 ARCHES trial shows XTANDI (enzalutamide) plus androgen deprivation therapy (ADT) reduces risk of death by 30%

Pfizer advances vision for future of cancer care at ASCO 2025 Annual Meeting

Multiple studies show the combination potential of vedotin antibody-drug conjugates (ADCs) with pembrolizumab, including the first Phase 1 data in thoracic cancers for two first-in-class ADCs

Bayer submits supplemental new drug application to USFDA seeking expanded indication for NUBEQA

NUBEQA is currently indicated for the treatment of adult patients with mHSPC in combination with docetaxel and for non-metastatic castration-resistant prostate cancer (nmCRPC)