Bayer’s Nubeqa secures NICE recommendation for hormone-relapsed prostate cancer at risk of metastasis
pharmafile | October 23, 2020 | News story | Medical Communications, Sales and Marketing | Bayer, NCIE, Nubeqa, pharma
NICE has given its recommendation to Bayer’s androgen receptor inhibitor Nubeqa (darolutamide) in combination with androgen deprivation therapy (ADT) for the treatment of hormone-relapsed prostate cancer in adults at high-risk of developing metastasis.
The condition sees around 48,000 new cases per year in the UK, with one in three patients developing metastases within two years.
Phase 3 data supporting the decision indicated that the Nubeqa combo improved metastasis-free survival by a median of 40.4 months, compared to 18.4 months with placebo combined with ADT, meeting the study’s primary goal.
The combo also reduced the risk of death by 31% compared to the placebo group, with an overall survival rate of 83% after three years compared to 77% respectively across the two treatment groups.
“NICE’s positive recommendation of darolutamide helps to address an unmet need for hormone-relapsed non-metastatic prostate cancer or, as it is known, non-metastatic castration-resistant prostate cancer (nmCRPC) patients,” said Professor Amit Bahl, Consultant Clinical Oncologist, University Hospitals Bristol NHS Foundation Trust. “A new treatment option that significantly delays the development of metastases whilst also prolonging life, with a generally manageable safety profile is imperative for men diagnosed with nmCRPC, as we aim to ensure minimal disruption to their treatment and day-to-day lives. Men with nmCRPC typically have no symptoms so it’s critical that they can be treated early to delay the prostate cancer from spreading.”
Matt Fellows
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