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www.fdanews.com/articles/210331-mhra-approves-nubeqa-treatment-combination-for-advanced-form-of-prostate-cancer

MHRA Approves Nubeqa Treatment Combination for Advanced Form of Prostate Cancer

November 30, 2022

Bayer’s Nubeqa (darolutamide) plus androgen deprivation therapy (ADT) in combination with docetaxel has received marketing authorization from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of patients with metastatic hormone sensitive prostate cancer after the treatment showed a statistically significant 32.5 percent reduced risk of death.

Nubeqa works by blocking androgen receptors in cancer cells. Doing so blocks testosterone’s effects and inhibits the survival and proliferation of cancer cells.

The approval was made under Project Orbis, an international partnership that includes the U.S., Australia and other countries to accelerate review and approval of promising cancer therapies.

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