Bayer Seeks European Approval For Third Indication For Cancer Drug Darolutamide

On Monday, Bayer AG BAYRY submitted an application to the European Medicines Agency (EMA) for the oral androgen receptor inhibitor (ARi) darolutamide.

Bayer is seeking approval for the use of darolutamide in combination with androgen deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC).

The compound is already approved in mHSPC, under the brand name Nubeqa, in combination with ADT and docetaxel in over 80 markets.

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The compound is also approved in combination with ADT for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease in more than 85 countries.

Results from the Phase III ARANOTE trial, on which this new submission is based, showed that darolutamide plus ADT significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT (HR 0.54), in patients with mHSPC.

Consistent benefits in radiological progression-free survival (rPFS) were observed across prespecified subgroups, including patients with high- and low-volume mHSPC.

Treatment-emergent adverse events (TEAEs) were low and similar between treatment groups and the safety analysis reconfirmed the established tolerability profile of darolutamide as observed in the ARAMIS and ARASENS trials.

The ARANOTE results were simultaneously presented at the 2024 ESMO Congress and published in The Journal of Clinical Oncology.

Darolutamide is developed jointly by Bayer and a Finnish pharmaceutical company, Orion Corporation.

In June, a Pennsylvania judge drastically reduced a $2.25 billion verdict against Bayer, cutting it down to $400 million in a case involving a man who claimed he developed cancer from using the company’s Roundup weedkiller.

Image by PDPics from Pixabay

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