December 16, 2019
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.
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.