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ARTICLE | Company News

July 31 Company Quick Takes: Bayer, Orion win approval in prostate cancer; plus Keytruda, Roche-Spark, UC v. Broad and more

July 31, 2019 11:18 PM UTC

Bayer, Orion androgen receptor inhibitor approved for prostate cancer
FDA approved an NDA for Nubeqa darolutamide from Bayer AG (Xetra:BAYN) and Orion Corp. (HSE:ORNAV; HSE:ORNBV) to treat non-metastatic castration-resistant prostate cancer. The oral androgen receptor inhibitor, which was under Priority Review, prevents androgen receptor-mediated transcription by inhibiting translocation of the androgen receptor to the nucleus -- potentially providing a more complete blockade of the androgen signaling pathway (see "Prostate Cancer Disrupted").

Keytruda gets U.S. approval in esophageal cancer
FDA approved an sBLA for Keytruda pembrolizumab as monotherapy for previously treated, recurrent locally advanced or metastatic PD-L1-positive squamous cell carcinoma of the esophagus. Merck & Co. Inc. (NYSE:MRK) said it is the first anti-PD-1 therapy approved for the indication...