New Indication for Zytiga
February 8, 2018 – The U.S. FDA has approved a new indication for Zytiga® (abiraterone acetate), manufactured by Janssen Pharmaceuticals. The drug is now approved to metastatic high-risk castration-sensitive prostate cancer (CSPC), when used in conjunction with prednisone.
In a clinical study, Zytiga used in combination with prednisone lowered patients’ risk of death by 38% compared to placebo. Participating patients had newly diagnosed metastatic high-risk CSPC. The prognosis for such patients is typically poor.
Recommended dosing under the new indication is 1,000mg of Zytiga along with 5mg of prednisone once daily. A CYP17 inhibitor, Zytiga is also approved to treat metastatic castration-resistant prostate cancer (CRPC) when used with prednisone. It is available in both 250mg and 500mg capsules.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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.