Bayer Gets FDA Approval for Prostate-Cancer Drug

Dow Jones

Jun 04, 2025

By Katherine Hamilton

Bayer said it received approval from the Food and Drug Administration for its drug Nubeqa, which treats patients with a certain type of prostate cancer.

The German life-sciences company said Tuesday the approval is based on positive results from a phase 3 trial. The trial results showed a 46% reduction in the risk of radiographic progression or death among patients taking Nubeqa in combination with another form of therapy.

There were 669 patients in the randomized, placebo-controlled trial, Bayer said.

Nubeqa is indicated in the U.S. for the treatment of adults with metastatic and non-metastatic castration-sensitive prostate cancer.

Write to Katherine Hamilton at katherine.hamilton@wsj.com

(END) Dow Jones Newswires

June 03, 2025 19:15 ET (23:15 GMT)

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The trial results showed a 46% reduction in the risk of radiographic progression or death among patients taking Nubeqa in combination with another form of therapy. \n\n\n  There were 669 patients in the randomized, placebo-controlled trial, Bayer said. \n\n\n  Nubeqa is indicated in the U.S. for the treatment of adults with metastatic and non-metastatic castration-sensitive prostate cancer. \n\n\n \n\n\n  Write to Katherine Hamilton at katherine.hamilton@wsj.com \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  June 03, 2025 19:15 ET (23:15 GMT)\n\n\n  Copyright (c) 2025 Dow Jones & Company, Inc.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":true,"code":"91000000","status":"200"}}}