Bayer BAYRY announced that the FDA has accepted its supplemental new drug application (sNDA) for Nubeqa (darolutamide). The sNDA is seeking label expansion of Nubeqa in combination with androgen ...

Triple therapy with darolutamide vs abiraterone for metastatic hormone-sensitive prostate cancer is associated with better clinical outcomes. Triplet therapy that includes darolutamide vs ...

Darolutamide has been fast-tracked by the FDA for non-metastatic CRPC, which is associated with a high risk for cancer progression and mortality, so a verdict could be speedy.

Israeli pharmaceutical company RedHill Biopharma has initiated a placebo-controlled Phase II trial to assess the combination of opaganib and darolutamide in treating metastatic castrate-resistant ...

Darolutamide plus ADT vs placebo plus ADT improves oncologic outcomes in patients with mHSPC regardless of disease volume, although the benefit is more pronounced among patients with low-volume ...

In a live event, Ganesh V. Raj, MD, PhD, discussed the drug-drug interactions and outcomes by disease volumes across ARPI trials in mHSPC.

The optimistic assessment of the revenue potential for androgen receptor inhibitor Nubeqa (darolutamide) follows the publication of the results of the phase 3 ARASENS trial in the New England ...

Metastasis-directed therapy (MDT) plus androgen deprivation therapy (ADT) for oligometastatic prostate cancer (omPC): Primary results of the EXTEND continuous ADT (cADT) basket plus combined analysis ...

Data will include a subgroup analysis from the investigational Phase III ARANOTE trial, evaluating the efficacy and safety of NUBEQA ® (darolutamide) and androgen-deprivation therapy (ADT ...