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Bayer’s Nubeqa receives MHRA approval to treat metastatic prostate cancer

The treatment will be made available immediately through an early access deal with NHS England


Bayer’s Nubeqa (darolutamide) tablets plus androgen deprivation therapy (ADT), in combination with docetaxel, have been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC).

Nubeqa, which is already available on the NHS for patients with localised prostate cancer, was reviewed and approved through Project Orbis, an international programme to speed up the approval process of promising cancer drugs.

The commercial agreement between NHS England and Bayer is the first for a prostate cancer therapy and enables early access for eligible NHS patients in England for this indication while the National Institute for Health and Care Excellence (NICE) completes its ongoing appraisal.

“We are delighted that men with prostate cancer in England will have early access to another innovative treatment option,” said Antonio Payano, chief executive officer, Bayer UK and Ireland.

“It’s vital that NHS patients are able to benefit from the best standard of care and full range of emerging therapies today and in the future. It requires direct and sustained collaboration between government, the NHS and the life sciences sector to properly realise these shared ambitions.”

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

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

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

Nubeqa, developed jointly by Bayer and Orion, is an oral androgen receptor inhibitor with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells.

NHS national director for cancer, Professor Peter Johnson, said: “It is vital the NHS continues to diagnose patients as early as possible and expand our arsenal of cutting-edge treatments in order to increase the chances of people surviving.”

Article by
Emily Kimber

28th November 2022

From: Regulatory, Healthcare



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