Bayer and Orion Corporation-developed prostate cancer treatment approved by NHS England and MHRA
NHS England and the Medicines and Healthcare products Regulatory Agency have approved a prostate cancer treatment, developed jointly by Bayer and Orion Corporation – the first of its kind to have been made available following accelerated regulatory approval under Project Orbis.
The treatment is Nubeqa (Darolutamide) and androgen deprivation therapy (ADT) in combination with docetaxel, which will now be used to treat patients with metastatic hormone sensitive prostate cancer (mHSPC). It was originally licensed to treat patients with non-metastatic castration-resistant prostate cancer (nmCRPC) in 2020.
The approval came after data from the ARASENS phase 3 clinical trial was presented: 1,305 patients participated in the trial, and the combination treatment showed a statistically significant 32.5% reduced risk of death. The trial’s secondary endpoints were time to pain progression and time to first symptomatic skeletal event.
Project Orbis is a programme to review and approve promising cancer drugs, helping patients to access treatments faster. It is coordinated by the FDA and involves, alongside the MHRA: the regulatory authorities of Australia (Therapeutic Goods Administration (TGA)); Canada (Health Canada); Singapore (Health Sciences Authority (HSA)); Switzerland (Swissmedic); and Brazil (Agência Nacional de Vigilância Sanitária (ANVISA)).
Dr Ursula McGovern, FRCP consultant medical oncologist, University College London Hospitals NHS Foundation Trust and UK chief investigator in the study, said, “Intensification of treatment was generally well tolerated, and this novel combination […] should be considered for appropriate patients with mHSPC.”
CEO of Bayer UK & Ireland, Antonio Payano, said, “We are delighted that men with prostate cancer in England will have early access to another innovative treatment option. 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.”