Bayer gets USFDA priority review for darolutamide plus docetaxel to treat metastatic hormone-sensitive prostate cancer
Darolutamide is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.
Berlin: Bayer has announced that the U.S. Food and Drug Administration (USFDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for the oral androgen receptor inhibitor (ARi) darolutamide in combination with docetaxel for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC).
Prostate cancer is the second most commonly diagnosed malignancy 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.
At the time of diagnosis, most men have localized prostate cancer, meaning their cancer is confined to the prostate gland and can be treated with curative surgery or radiotherapy. Upon relapse, when the disease will metastasize or spread, the disease is hormone-sensitive and androgen deprivation therapy (ADT) is the cornerstone of treatment. Current treatment options for men with metastatic hormone-sensitive prostate cancer (mHSPC) include hormone therapy, such as ADT, androgen receptor pathway inhibitors plus ADT or a combination of docetaxel chemotherapy and ADT. Despite these treatments, a large proportion of men with mHSPC will eventually experience progression to metastatic castration-resistant prostate cancer (mCRPC), a condition with high morbidity and limited survival.
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