Xtandi Receives New Indication

December 16, 2019 – The U.S. FDA has approved a new indication for Xtandi® (enzalutamide), manufactured by Pfizer, to treat patients who have metastatic castration-sensitive prostate cancer (mCSPC). The product was first approved in 2012 and is also indicated to treat castration-resistant prostate cancer (CRPC).

Prostate cancer is one of the most common cancers diagnosed in men in the United States. Although the disease is highly treatable, survival rates drop sharply when it becomes metastatic – from almost 100% to 30%. Treatments for prostate cancer include radiation therapy, medication, hormone therapy, and surgical castration, also known as orchiectomy. The goal of an orchiectomy is to slow the advance of prostate cancer by reducing the level of androgens, a type of hormone that can affect how rapidly the cancer develops.

In a clinical study, treatment with Xtandi plus androgen deprivation therapy (ADT) reduced the risk of radiographic progression or death by 61% compared to placebo plus ADT. The new indication allows Xtandi to be used earlier in the course of treatment for certain patients who have prostate cancer.

Recommended dosing is 160mg (four 40mg capsules) taken by mouth once daily, with or without food. Patients should also take a gonadotropin-releasing hormone (GnRH) analog or should have had bilateral orchiectomy.