Bayer’s Nubeqa® (darolutamide) becomes the first treatment accepted in Scotland for treating men with non-metastatic castration-resistant prostate cancer (nmCRPC)

Bayer’s Nubeqa^® (darolutamide) becomes the first treatment accepted in Scotland for treating men with non-metastatic castration-resistant prostate cancer (nmCRPC)

Reading, 9 November, 2020 – Bayer is pleased to announce that following a full review, the Scottish Medicines Consortium (SMC) has accepted Nubeqa^® (darolutamide), a non-steroidal androgen receptor inhibitor (ARi), in its licensed indication for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease.¹

Darolutamide is the first treatment accepted for use within NHS Scotland for men with high-risk nmCRPC.¹ It is taken orally twice daily, and works by inhibiting the growth of prostate cancer cells.¹ The SMC concluded that darolutamide is a cost-effective treatment option for high-risk nmCRPC patients in Scotland and has recommended that darolutamide should be accepted for use in line with its full licensed indication.¹

The positive SMC announcement applies in the context of an approved NHS Scotland Patient Access Scheme (PAS) and follows the recent decision from the National Institute for Health and Care Excellence (NICE) last month recommending the use of darolutamide on the NHS in England and Wales.^1,2 Darolutamide is also the first treatment NICE has recommended in this indication.

Robert Jones, Professor of Clinical Cancer Research at University of Glasgow, said: “This is welcome news for Scottish patients with prostate cancer. This new treatment is now available for a group of patients whose cancer has not yet spread but where conventional hormone therapy is no longer fully controlling the disease. Darolutamide helps delay the spread of the cancer enabling patients to remain well for longer. I’d particularly like to thank the Scottish patients who took part in the trial which showed this treatment to be effective.”

Non-metastatic castration-resistant prostate cancer (nmCRPC) is a stage within castration-resistant prostate cancer (CRPC), where the cancer has not spread beyond the prostate but has continued to progress despite hormone therapy.³ Prostate cancer affects 1 in 10 men in Scotland during their lifetime.⁴ Studies have shown 10–20% of prostate cancer patients develop CRPC within five years of follow up and about one-third of men with nmCRPC go on to develop metastases within two years.⁵

This decision is based on the positive results of the Phase III ARAMIS trial evaluating the efficacy and safety of darolutamide plus ADT compared to placebo plus ADT, which demonstrated a significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS) of darolutamide plus ADT, with a median 40.4 months, versus 18.4 months for placebo plus ADT (HR 0.41, p<0.001).^1,3 Darolutamide continued to demonstrate a generally manageable safety profile at final analysis, when compared to ADT alone.⁶  The incidence of adverse events (AEs) after the start of treatment was similar in the two groups; no new safety signals were observed.⁶

The final overall survival (OS) data, a secondary endpoint from the Phase III ARAMIS trial, demonstrated a significant improvement in OS compared to placebo plus ADT, with a 31% reduction in risk of death (HR=0.69, 95% CI 0.53-0.88; p=0.003).⁶ The overall survival rate at three years was 83% (95% Cl 80-86%) in the darolutamide group and 77% (95% Cl 72-81%) in the placebo group.⁶

“We welcome the positive decision by the SMC for darolutamide, which will provide men with newly diagnosed advanced stage prostate cancer a treatment option that delays disease progression as well as improving overall survival. This is a major advance in treatment and fills a hitherto unmet need,” said Steve Allen, Patient Representative for Tackle Prostate Cancer. “Alongside further research and awareness, access to innovative treatments can help improve the care and welfare of men impacted by prostate cancer. Increasing awareness of prostate cancer cannot be underestimated – it is vital that men are diagnosed and treatment started as early as possible.”