MHRA Approves Nubeqa Treatment Combination for Advanced Form of Prostate Cancer

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.

Nubeqa is a medicine used to treat men with prostate cancer. It is used when the cancer is castration-resistant (worsens despite treatment to lower testosterone levels, including surgical removal of the testes) and is at high risk of metastasis (spreading to other parts of the body). Nubeqa contains the active substance darolutamide.

November 30, 2022

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