Xtandi (enzalutamide) received a supplemental New Drug Application (sNDA). The drug received approval for the treatment of metastatic castration-sensitive prostate cancer.
Xtandi approved for the treatment of metastatic castration-sensitive prostate cancer. The drug already approved for treating non-metastatic and metastatic castration-resistant prostate cancer.
The drug approval was based on the ARCHES Phase 3 study, which enrolled 1,150 patients with mCSPC. The patients received 160 mg of Xtandi or placebo and continued on a luteinizing hormone-releasing hormone. Xtandi plus androgen deprivation therapy (ADT) reduced radiographic progression or death by 61% compared to placebo. The safety analysis was consistent with previous trials. The frequent adverse events are hot flush, asthenic conditions, hypertension, fractures, and musculoskeletal pain.
Xtandi is indicated for the treatment of patients with castration-resistant prostate cancer (CRPC) and metastatic castration-sensitive prostate cancer (mCSPC).
FDA approved to Amarin Pharma Vascepa (ethyl eicosapentaenoic acid) as an adjunctive therapy to reduce the risk of cardiovascular events among adults with triglyceride levels of 150 milligrams per deciliter or higher. The drug is indicated in patients with stabilized cardiovascular disease or diabetes or two or more additional risks for cardiovascular diseases. Vascepa is the first therapy approved in the United States to reduce cardiovascular risk among patients with elevated triglyceride levels.
The approval is based on study which enrolled 8,179 patients who are either 45 years and older with history of coronary artery, cerebrovascular, carotid artery and peripheral artery disease, or 50 years and older with diabetes and additional risk factors for cardiovascular disease. Less chances of cardiovascular events were observed in patients who were on Vascepa.