BAYRY - Bayer's Nubeqa gets FDA approval for expanded use in prostate cancer subtype

• The U.S. Food and Drug Administration approved the expanded use of Bayer's ( OTCPK:BAYRY ) ( OTCPK:BAYZF ) medicine Nubeqa, in combination with docetaxel, to treat patients with metastatic hormone-sensitive prostate cancer (mHSPC).
• Nubeqa (darolutamide) was already approved in the U.S. to treat non-metastatic castration-resistant prostate cancer.
• The German conglomerate's supplemental New Drug Application (sNDA) for darolutamide had received the FDA's priority review in May.
• The approval was backed by data from a phase 3 trial called ARASENS.
• Bayer said the approval was under the FDA's Real-Time Oncology Review pilot program, which aims to provide a more efficient review to ensure that effective cancer treatments are available to patients as early as possible.
• The company added that ongoing reviews are also being conducted under the FDA's Project Orbis initiative, which provides for concurrent submission and review of cancer therapies among participating international health authorities.

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