Bayer Seeks European Approval For Third Indication For Cancer Drug Darolutamide
Portfolio Pulse from Vandana Singh
Bayer AG has submitted an application to the European Medicines Agency for the approval of darolutamide, an oral androgen receptor inhibitor, for use in combination with androgen deprivation therapy in patients with metastatic hormone-sensitive prostate cancer. The application is based on positive Phase III ARANOTE trial results.

October 14, 2024 | 3:34 pm
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POSITIVE IMPACT
Bayer AG has applied for EMA approval for darolutamide in mHSPC treatment, based on positive trial results. This could expand its market presence and boost sales.
The application for EMA approval of darolutamide in a new indication could lead to increased market penetration and sales for Bayer. The positive Phase III trial results support the likelihood of approval, which would be beneficial for Bayer's oncology portfolio.
CONFIDENCE 90
IMPORTANCE 70
RELEVANCE 80