Enzalutamide Has Additional Benefits For Castration-resistant Prostate Cancer Patients

CHANGSHA, China - Jan. 29, 2021 - PRLog -- In 2018 and 2019, the German Institute for Quality and Efficiency in Health Care (IQWiG) already investigated whether the drug enzalutamide has an advantage in comparison with the appropriate comparator therapy, i.e. in comparison with watchful waiting while maintaining ongoing conventional androgen deprivation therapy (ADT), for adult men with high-risk non-metastatic castration-resistant prostate cancer.

On the basis of the first and the second data cut-offs of the PROSPER study, an added benefit was not proven. Since the study was not yet completed, the Federal Joint Committee (G-BA) limited its corresponding decision. After expiry of the decision, IQWiG reassessed the drug on the basis of the third data cut-off of the study, which had been completed in the meantime. There is now a hint of considerable added benefit - in particular due to the longer overall survival under treatment with enzalutamide.

New data for the assessment of mortality and side effects

Regarding the outcome categories of morbidity and health-related quality, there were no new findings in comparison with the first assessment, so that the result of the assessment for these outcomes has not changed: In each case, an added benefit is not proven.

In the outcome category of mortality, there was now a hint of considerable added benefit on the basis of the third data cut-off: On average, patients in the enzalutamide arm of the study survived notably longer than in the comparator arm.

In the last outcome category, the side effects, the picture is mixed: There was a hint of a major advantage of enzalutamide for renal and urinary disorders, but it is not completely clear whether these really were side effects of treatment or symptoms of the disease. Furthermore, there were hints of disadvantages of the drug in comparison with watchful waiting while maintaining ongoing ADT for four further specific side effects; their extents were minor to considerable. However, these disadvantages did not raise doubts about the advantages, particularly the longer overall survival, so that the overall assessment resulted in a hint of considerable added benefit of enzalutamide in comparison with the appropriate comparator therapy.

Prostate cancer is a common cancer in men. Enzalutamide (trade name Xtandi) is a type of hormone therapy. It is a treatment for prostate cancer that has spread to other parts of the body (advanced prostate cancer). Huateng Pharma (https://en.huatengsci.com/), a professional pharmaceutical intermediates and APIs manufacturer supplies enzalutamide intermediates' process development and scale-up production with capacities varying from gram to kilograms and multi tons.

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