{"id":14206,"date":"2024-11-22T18:41:29","date_gmt":"2024-11-22T10:41:29","guid":{"rendered":"https:\/\/flcube.com\/?p=14206"},"modified":"2024-11-22T18:46:53","modified_gmt":"2024-11-22T10:46:53","slug":"bayers-nubeqa-files-for-fda-approval-in-mhspc","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=14206","title":{"rendered":"Bayer’s Nubeqa Files for FDA Approval in mHSPC"},"content":{"rendered":"\n

German pharmaceutical company Bayer AG (ETR: BAYN<\/a>) has announced that the US Food and Drug Administration (FDA) has accepted its supplemental new drug application (sNDA) for Nubeqa (darolutamide) for review. Bayer is seeking approval for its androgen receptor inhibitor (ARi) in combination with androgen deprivation therapy (ADT) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).<\/p>\n\n\n\n

Nubeqa’s Previous Approvals and Current Indications<\/strong>
Nubeqa, co-developed with Finnish pharmaceutical company Orion Corporation, has been previously approved for the treatment of adult patients with mHSPC in combination with docetaxel. It is also approved for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC). The current filing is aimed at expanding the drug’s indications for mHSPC treatment in combination with ADT.<\/p>\n\n\n\n

Supporting Data from Phase III ARANOTE Study<\/strong>
The submission is supported by positive results from the Phase III ARANOTE study. The study demonstrated that the combination of Nubeqa and ADT significantly improved radiographic progression-free survival (rPFS) in patients compared to a placebo combined with ADT. These findings suggest that the Nubeqa\/ADT combo could offer a meaningful advancement in the treatment of mHSPC.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

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