2022-08-10| Trials & Approvals

Bayer, Orion’s Prostate Cancer Drug Gets Approval For Second Indication

by Joy Lin
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Bayer and Orion Corporation, a Finnish pharma, has announced the US FDA approval of darolutamide in combination with docetaxel for metastatic hormone-sensitive prostate cancer (mHSPC). 

An oral androgen receptor inhibitor (ARi), darolutamide was first approved by the FDA in 2019 for non-metastatic castration-resistant prostate cancer (nmCRPC). It has since been approved under the brand name “Nubeqa” in over 70 markets around the world, including the EU, Japan and China. 

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Boosting Overall Survival 

Prostate cancer is the second most commonly diagnosed cancer in men worldwide. In 2020, an estimated 1.4 million men were diagnosed with prostate cancer, and about 375,000 died from the disease worldwide. 

Darolutamide strongly binds to and inhibits androgen receptors on prostate cancer cells, thereby inhibiting their growth. Preclinical models and neuroimaging in healthy humans show that the drug has low potential of crossing the blood-brain barrier, which is supported by the low incidence of side effects related to the central nervous system compared to placebo. 

The recent US approval is based on data from the Phase 3 Arasens trial which showed that darolutamide plus androgen deprivation therapy (ADT) and docetaxel significantly lowered the risk of death by 32.5% compared to ADT plus docetaxel. 

While darolutamide is well-tolerated in mHSPC and nmCRPC, side effects include nausea, diarrhea, fatigue and ischemic heart disease among others. 

Additional investigation of darolutamide is underway across various stages of prostate cancer. Studies include the Phase 3 Aranote trial evaluating darolutamide plus androgen deprivation therapy (ADT) versus ADT alone for metastatic hormone-sensitive prostate cancer (mHSPC). The drug is also being evaluated as an adjuvant treatment in high-risk localized prostate cancer, in a Phase 3 led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP). 

Darolutamide is being jointly developed and marketed by Orion and Bayer. In 2014, Bayer paid $68 million upfront to commercialize the drug globally, while Orion received an option to co-promote the drug in Europe. The Finnish pharma could also receive substantial milestone payments and royalties on net sales of the product. 

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