In a significant advancement for prostate cancer treatment, the Medicines and Healthcare products Regulatory Agency (MHRA) and NHS England have approved and made available a novel combination therapy developed jointly by Bayer and Orion Corporation. The treatment combines NUBEQA (Darolutamide) and Androgen Deprivation Therapy (ADT) with docetaxel for patients with metastatic hormone-sensitive prostate cancer (mHSPC).
Clinical Trial Results Demonstrate Strong Efficacy
The approval is supported by compelling data from the ARASENS phase 3 clinical trial, presented at the 2022 ASCO GU Cancers Symposium and published in The New England Journal of Medicine. The large-scale study, involving 1,305 patients, demonstrated that the combination therapy achieved a statistically significant 32.5% reduction in mortality risk. The trial also evaluated secondary endpoints including time to pain progression and time to first symptomatic skeletal event.
Addressing a Significant Medical Need
The treatment's approval addresses a crucial healthcare challenge in the UK, where over 52,000 prostate cancer cases are diagnosed annually, including more than 15,000 new cases of metastatic prostate cancer. This builds upon the therapy's initial 2020 license for treating non-metastatic castration-resistant prostate cancer (nmCRPC).
Early Access Through Innovative Partnership
Through a strategic commercial agreement with Bayer, NHS England has positioned itself as Europe's first healthcare system to fast-track this medicine. This arrangement ensures eligible patients in England can access the treatment while the NICE assessment process continues.
Dr. Ursula McGovern, FRCP consultant medical oncologist at University College London Hospitals NHS Foundations Trust and UK chief investigator in the study, noted, "Intensification of treatment was generally well tolerated, and this novel combination [...] should be considered for appropriate patients with mHSPC."
Antonio Payano, CEO of Bayer UK & Ireland, emphasized the significance of this development: "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."
Regulatory Innovation Through Project Orbis
The accelerated approval was facilitated through Project Orbis, an international program coordinated by the US FDA that expedites review of promising cancer treatments. The initiative involves regulatory authorities from multiple countries, including Australia, Canada, Singapore, Switzerland, and Brazil, alongside the MHRA.
Ongoing research continues to explore darolutamide's potential across various stages of prostate cancer, signaling possible future expansions of its therapeutic applications.
