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Bayer’s Nubeqa combination recommended by NICE to treat metastatic prostate cancer

More than 47,000 new cases of prostate cancer are diagnosed every year in England


Bayer’s Nubeqa (darolutamide) has been recommended by the National Institute for Health and Care Excellence (NICE) as part of a combination treatment for patients with metastatic hormone-sensitive prostate cancer (mHSPC).

The final draft guidance from NICE specifically recommends Nubeqa tablets in combination with androgen deprivation therapy (ADT) and docetaxel.

The decision follows the Medicines and Healthcare products Regulatory Agency’s approval of the combination in November last year under Project Orbit, an international programme to speed up the approval process of promising cancer drugs.

Bayer and NHS England have since had a commercial agreement to enable clinicians to arrange early access. The latest decision by NICE now allows additional eligible patients with mHSPC in England and Wales to receive the medication.

The recommendation was based on the phase 3 ARASENS trial, which showed that adding Nubeqa to standard ADT and docetaxel improved overall survival, compared to ADT plus docetaxel and placebo.

The results, published in the New England Journal of Medicine, also showed a 32.5% reduction in the risk of death in the Nubeqa group compared to the placebo.

Antonio Payano, chief executive officer of Bayer UK and Ireland, said: “The positive recommendation by NICE paves the way for additional eligible patients in England and Wales to benefit from this innovative medication, following the early access we agreed with NHS England approximately six months ago.

“We remain committed to investigating the potential of [Nubeqa] in prostate cancer with additional clinical trials and working with the relevant UK authorities to help make it available to as many eligible patients as possible.”

Prostate cancer is the most common cancer in men, with around 47,000 cases diagnosed in England each year. Around 9,000 patients go on to develop metastatic prostate cancer.

Nubeqa, jointly developed by Bayer and Finnish pharmaceutical company Orion, is an oral androgen receptor inhibitor that works to impede the receptor function and the growth of prostate cancer cells.

The drug is currently approved as part of combination treatment for patients with mHSPC, as well as patients with non-metastatic castration-resistant prostate cancer, who are at high risk of developing metastatic disease.

Article by
Emily Kimber

22nd May 2023

From: Regulatory



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