Europe approves a new indication for Xtandi, from Astellas, for prostate cancer
Source: actasanitaria.com
The European Commission has approved a new indication of enzalutamide, a drug whose trade name is Xtandi and which was registered by the pharmaceutical company Astellas Pharma, for the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPCnm). .
“Enzalutamide thus becomes one of the first approved treatments for this critical phase of the disease, currently associated with a significant medical need not covered,” explains this laboratory, which adds that it was already approved by the European Commission in June 2013 and , currently, is indicated for the treatment of adult men with asymptomatic or mildly symptomatic metastatic CRPC after the failure of androgen deprivation treatment (ADT) and in those who are not yet chemically indicated or whose disease has progressed during or after treatment with docetaxel.
The approval is based on the results of the pivotal clinical trial in Phase III Prosper, evaluation of enzalutamide plus ADT versus placebo plus ADT in patients with cMSPC and a rapid increase in prostate-specific antigen (PSA) levels, defined as a time of PSA dubbing of 10 months or less or a PSA level> 2ng / ml.
“This new approval is an important progress for men with CRPC, who can now use enzalutamide as a therapeutic option regardless of whether they have detectable metastatic disease or not,” says Astellas Pharma Medical Director, Dr. Bernhardt G. Zeiher. “We are committed and working with European health authorities to ensure that enzalutamide is available as soon as possible for men with high-risk cMSPC,” he adds.
In Distefar we echo these new advances in the treatment of adult men with prostate cancer.
