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Bayer’s Nubeqa receives FDA approval to treat metastatic prostate cancer

The risk of death was reduced by 32% by adding the drug to standard therapy


Bayer’s Nubeqa (darolutamide) tablets, in combination with docetaxel, have been approved by the US Food and Drug Administration (FDA) to treat adults with metastatic hormone-sensitive prostate cancer (mHSPC).

The decision was based on the ARASENS trial, which demonstrated that adding Nubeqa to standard androgen deprivation therapy (ADT) and docetaxel chemotherapy led to a statistically significant improvement in overall survival compared to ADT plus docetaxel and placebo.

The results, published in the New England Journal of Medicine in February, also showed the risk of death was significantly reduced by 32.5% in the Nubeqa group compared to the placebo.

Nubeqa is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells.

Bayer’s development partner, Orion, reported that prostate cancer remains the second leading cancer-related cause of death among men in the US, with up to one-third of patients developing metastatic disease.

At the time of diagnosis, most men have localised 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 metastasise or spread, ADT is the cornerstone of treatment for this hormone-sensitive disease.

The incidence of mHSPC has increased by 72% in the US over the past ten years, with approximately one in three patients who are diagnosed with mHSPC surviving the disease for five years or longer.

Current treatment options for men with 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 limited survival.

The drug is currently approved in more than 70 markets around the world, including the US, EU Japan and China, to treat adults with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.

Article by
Emily Kimber

9th August 2022

From: Research, Regulatory



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