EU approves Nubeqa for castration-resistant prostate cancer .- Orion + Bayer
The approval is based on Phase III ARAMIS trial results showing a statistically significant improvement in metastasis-free survival (MFS) for darolutamide plus androgen deprivation therapy (ADT) versus placebo plus ADT, and a favorable safety profile. Results demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS) of darolutamide plus ADT, with a median of 40.4 months, versus 18.4 months for placebo plus ADT (p<0.001), and a favorable safety profile. the compound is indicated for the treatment of men with non-metastatic castration-resistant prostate cancer (nmcrpc), who are at high risk of developing metastatic disease.></0.001),>
Related news and insights
Novartis announced that results of the Phase III VISION study evaluating 177Lu-PSMA-617, a targeted radioligand therapy, plus best standard of care (SOC) demonstrated significant improvement in overall survival (OS) compared to SOC alone, in patients with progressive PSMA-positive metastatic castration-resistant prostate cancer (mCRPC).
Astellas Pharma Inc. announced that the European Commission (EC) has approved an additional indication for the oral once-daily therapy Xtandi (enzalutamide) for adult men with metastatic hormone-sensitive prostate cancer (mHSPC, also known as metastatic castration-sensitive prostate cancer or mCSPC).
The Janssen Pharmaceutical Companies of Johnson & Johnson announced that regulatory submissions based on the Phase III ACIS study, which evaluated the combination of Erleada (apalutamide) and Zytiga (abiraterone acetate) plus prednisone in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC), will not be pursued.