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Bayer’s Nuveca Receives MHRA Approval for Treatment of Metastatic Prostate Cancer



Bayer’s nubeca (darolutamide) tablets and androgen deprivation therapy (ADT) in combination with docetaxel are approved by the Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) .

Already available in the NHS for patients with localized prostate cancer, Nubeqa was reviewed and approved through Project Orbis, an international program to speed up the approval process for promising cancer treatments.

The commercial agreement between NHS England and Bayer is the first for the treatment of prostate cancer, allowing eligible NHS patients in the UK for this indication to be to enable early access.

Antonio Payano, Bayer UK & Ireland Chief Executive Officer, said:

“It is vital that NHS patients can benefit from the best standard of care and new treatments of all kinds, now and in the future. , requires direct and sustained cooperation between life science sectors.”

This decision was based on the Phase 3 ARASENS trial, which showed that the addition of Nubeqa to standard ADT and docetaxel chemotherapy improved overall survival compared to ADT plus docetaxel and placebo. I was.

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

Prostate cancer is the most common cancer in men, with approximately 47,000 cases diagnosed each year in the UK, according to NHS England reports. About 9,000 patients develop metastatic prostate cancer.

Co-developed by Bayer and Orion, Nubeca is an oral androgen receptor inhibitor with a unique chemical structure that binds to the receptor with high affinity and exhibits potent antagonistic activity, thereby altering receptor function and prostate cancer. Inhibits cell proliferation.

Professor Peter Johnson, Director of Cancer, NHS, said:




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