Nubeqa™ (darolutamide) receives EU approval for patients with metastatic HSPC based on positive results from the pivotal Ph 3 ARANOTE trial
“The third European approval of darolutamide represents a significant step forward for men with advanced prostate cancer,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “Darolutamide is the first androgen receptor inhibitor to show clinically meaningful health-related quality of life benefits, offering patients an effective and well tolerated treatment. Backed by compelling clinical data from the ARANOTE, ARASENS, and ARAMIS trials, we believe darolutamide has the potential to become a leading therapy across various stages of prostate cancer. We are committed to ensuring its broad availability to benefit as many eligible patients as possible.”
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