Prostate cancer, towards the approval of a new therapy for advanced forms
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There is news for patients with metastatic hormone sensitive prostate cancer (mHSPC). For the treatment of this tumour, (CHMP) of the European Medicines Agency has in fact just recommended the use of darolutamide, a second generation oral androgen receptor inhibitor (ARi), plus androgen deprivation therapy (ADT) in combination with docetaxel. It is now awaiting marketing authorization in the European Union (EU) in the coming months.
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Prostate cancer
Prostate cancer is the most frequent in men in almost all northern and western European countries (including Italy), while it is the second most common in the male population worldwide. Most of these patients develop progressive metastatic castration-resistant prostate cancer (mCRPC), a condition with low long-term survival. “Despite significant advances, disease progression and the onset of debilitating symptoms remain a common factor for many men with mHSPC,” comments Bertrand Tombal, Professor of Urology at the Université Catholique de Louvain (UCL) and Cliniques Universitaires Saint-Luc of Brussels, Belgium: “The access of these patients to therapeutic options that not only improve mortality, but also delay the time to progression of symptoms is crucial”.
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The CHMP decision is based on the results of the Arasens study, the only randomised, Phase III, multicentre, double-blind study designed to compare the use of darolutamide – in combination with docetaxel plus androgen deprivation therapy versus standard care recommended by guidelines. The trial involved more than 1,300 patients: “Arasens – continues Tombal – is the first study that demonstrates the benefits of darolutamide plus ADT in combination with docetaxel, both in reducing the risk of death and in limiting the deterioration of quality of life”.
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The new drug
Darolutamide is already approved for the treatment of patients with non-metastatic castration-resistant prostate cancer who are at high risk of developing metastases. In its second indication, namely in metastatic hormone-sensitive prostate cancer, it is instead already approved in the United States and in some other countries. “With the CHMP’s positive opinion, darolutamide has the potential to become a new standard of care for eligible prostate cancer patients,” said Christine Roth, member of the Executive Committee of the Pharmaceuticals Division and Director Oncology SBU at Bayer, the co-developer with the Finnish Orion Corporation -. “With darolutamide’s unprecedented survival data and minimal impact on the daily lives of patients with high-risk mHSPC and nmCRPC, following regulatory approval we will work to ensure that the more patients may benefit from darolutamide. This recommendation – she concludes – represents another step forward in our mission to redefine living with prostate cancer in the various stages of the disease ”.
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