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

2023-05-22

临床结果临床3期上市批准

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).

BayerinaNubeqat darolutamidem NICE specifically recommendsNational Institute for Health and Care Excellence (NICE) therapy (ADT) and docetaxel.metastatic hormone-sensitive prostate cancer (mHSPC)

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

Bayer and NHS England havMedicines and Healthcare products Regulatory Agencyians to arrange early access. The latest decision by NICE now allows additional eligible patients with mHSPC in England and Wales to receive the mecanceron.

Bayerecommendation 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% rNubeqaon in the risk of deadocetaxel Nubeqa group compared to the placebo.docetaxel

Antonio Payano, chief executive officer of Bayer UK and Ireland, said: “The positive recommendation by NICE paves the wayNubeqadditional 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 pBayer UK 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 aNubeqa47,00prostate cancered in England each year. Around 9,000 patients go on to develop metastatic prostate cancer.

Prostate cancer developed by Bayer cancernnish pharmaceutical company Orion, is an oral androgen receptor inhibitor that works to impede the recepmetastatic prostate cancerh of prostate cancer cells.

Nubeqaug is currently approveBayerpart of combination treatment for patients with mHSPC,androgen receptornts with non-metastatic castration-resistant prostate cancer, who are atprostate cancereveloping metastatic disease.

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