Bayer, Orion Get FDA OK for Nubeqa in Nonmetastatic Castration-Resistant Prostate Cancer

By Colin Kellaher

Germany's Bayer AG (BAYN.XE) and Finland's Orion Oyj (ORNBV.HE) said the U.S. Food and Drug Administration approved Nubeqa, an androgen receptor inhibitor jointly developed by the pharmaceutical companies to treat men with nonmetastatic castration-resistant prostate cancer.

Bayer and Orion said the approval is based on a Phase 3 study in which Nubeqa plus androgen deprivation therapy showed a highly significant improvement in the primary efficacy endpoint of metastasis-free survival.

Nubeqa was approved under the FDA's priority-review designation. The agency grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period to six months from the standard 10 months.

The companies said Bayer has filed for approval of Nubeqa in the European Union and Japan, and with other health authorities.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

July 31, 2019 06:17 ET (10:17 GMT)

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