`Mylan Laboratories Limited v. Aventis Pharma S.A. IPR2016-00712
`
`
`
`3/13/2017
`
`FDA Grants Expanded Indication for Enzalutamide (Xtandi)
`
`peripheral edema, dyspnea, musculoskeletal pain, weight decreased, headache, hypertension, and
`dizziness/vertigo.
`
`In clinical trials, seizures occurred in 0.9% of patients receiving enzalutamide who previously received
`docetaxel and 0.1% of patients who were chemotherapy—naive. "There is no clinical trial experience re-
`administering [enzalutamide] to patients who experienced a seizure, and limited clinical trial experience
`in patients with predisposing factors for seizure," the companies say.
`
`Enzalutamide is not indicated for use in women.
`
`Full prescribing information for enzalutamide is available on the drug Web site.
`
`Comment
`
`fl
`
`E
`
`fl
`
`L_J
`
`Commenting is limited to medical professionals. To comment please Log-in.
`
`LATEST IN HEMATOLOGY-ONCOLOGY
`
`SRS for Brain Mets: How Many Lesions Can It Safely Treat?
`
`Some Cancer Patients 'Hyperprogress' on Immunotherapy
`
`Society of lnterventional Oncology Formalizes Subspecialty
`
`'|matinib Changed Everything‘: The Future Is Now More Hopeful
`
`Known Cancer Prevention Strategies Must Be Implemented
`
`Medscape Medical News ©WebMD, LLC
`
`Heartwire © WebMD, LLC
`
`WebMD Health News © WebMD, LLC
`
`Reuters Health Information ©
`
`Send comments and news tips to news@medscape.net.
`
`Cite this article: FDA Grants Expanded Indication for Enzalutamide (Xtandi). Medscape. Sep 11, 2014.
`
`All material on this website is protected by copyright, Copyright © 1994-2017 by WebMD LLC.
`This website also contains material copyrighted by 3rd parties.
`
`http://www.medscape.com/viewarticle/831548
`
`2/2
`
`