23 October 2020 - Positive recommendation based on Phase 3 ARAMIS trial data in which darolutamide plus androgen deprivation therapy showed a statistically significant improvement in metastasis-free survival, with a median 40.4 months, compared to 18.4 months for placebo plus androgen deprivation therapy (HR 0.41, p<0.001).

Bayer announced today that the National Institute for Health and Care Excellence has recommended Nubeqa (darolutamide) with androgen deprivation therapy, within its marketing authorisation, as an option for treating hormone-relapsed prostate cancer in adults at high-risk of developing metastatic disease (also known as non-metastatic castration-resistant prostate cancer).

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