Posted from: Tuesday, August 07, 2018 - 01:29 PM - Present

Xtandi Receives Expanded Indication

July 13, 2018 – The U.S FDA has approved an expanded indication for Xtandi® (enzalutamide), manufactured by Astrellas and Pfizer. The drug is now approved to treat men who have castration-resistant prostate cancer (CRPC), including those who have non-metastatic CRPC.

In a clinical trial, Xtandi used alongside androgen deprivation therapy (ADT) reduced the risk of metastasis or death compared to treatment with ADT alone in men who had non-metastatic CRPC. Patients who received Xtandi and ADT achieved median progression-free survival times of 36.6 months compared to 14.7 months when treated with ADT alone. Delaying disease progression may improve overall outcomes for patients, as CRPC becomes more challenging to treat as it advances.

Xtandi first received FDA approval in 2012. Recommended dosing is four 40mg capsules (160mg total) taken once daily with or without food. Xtandi should be administered in conjunction with a gonadotropin-releasing hormone (GnRH) analog, unless the patient has undergone a bilateral orchiectomy.

 

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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.

 

Last Updated Sunday, November 18, 2018 - 10:24 AM.