Scottish Medicines Consortium greenlights Nubeqa for prostate cancer

pharmafile | November 10, 2020 | News story | Manufacturing and Production, Sales and Marketing  

The Scottish Medicines Consortium has approved Nubeqa for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.

This makes Nubeqa (darolutamide) the first treatment that has been accepted for use within NHS Scotland in this indication after the SMC concluded it to be cost effective. It is an oral medication taken twice a day that inhibits the growth of prostate cancer cells. 

“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,” explained Robert Jones, Professor of Clinical Cancer Research at University of Glasgow. “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.”

The decision to approve the treatment is based on positive results from the Phase 3 ARAMIS trial which evaluated the efficacy and safety of Nubeqa plus androgen deprivation therapy (ADT) compared to placebo plus ADT. The Nubeqa combo 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. The final overall survival (OS) data, a secondary endpoint from the Phase 3 ARAMIS trial, demonstrated a significant improvement in OS compared to placebo plus ADT, with a 31% reduction in risk of death 

“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,” remarked Steve Allen, Patient Representative for Tackle Prostate Cancer. 

He added: “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.” 

Conor Kavanagh

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