U.S. FDA Approves New Indication for the Use of XTANDI® (enzalutamide) Capsules for Patients with Metastatic Castration-Resistant Prostate Cancer - Seite 2

When compared to placebo, treatment with XTANDI also delayed time to initiation of chemotherapy and time to a skeletal related event.

The safety profile for XTANDI was updated to reflect data from both the AFFIRM and PREVAIL Phase 3 trials.

• Seizure occurred in 0.9% of patients receiving XTANDI who previously received docetaxel and 0.1% of patients who were chemotherapy-naive.  
• The most common adverse reactions (≥ 10%) that occurred more commonly (≥ 2% over placebo) in the XTANDI-treated patients from the two randomized clinical trials were asthenia/fatigue, back pain, decreased appetite, constipation, arthralgia, diarrhea, hot flush, upper respiratory tract infection, peripheral edema, dyspnea, musculoskeletal pain, weight decreased, headache, hypertension, and dizziness/vertigo.

"Enzalutamide has been studied and is approved for patients with metastatic prostate cancer that is resistant to primary hormonal therapy, a disease state we call castration-resistant prostate cancer. In this setting, enzalutamide has been shown to extend overall survival and significantly delay the progression of prostate cancer," said Tomasz M. Beer, M.D., F.A.C.P., co-principal investigator of the PREVAIL study, deputy director of the Knight Cancer Institute and professor of medicine at Oregon Health & Science University. "Furthermore, in the PREVAIL trial, the median time to initiating chemotherapy was delayed by 17 months with enzalutamide treatment as compared to placebo, so the result is a meaningful period of time during which men have their disease controlled without the need for chemotherapy."

A variation application to amend the European Marketing Authorisation Application based on the results of PREVAIL was validated for review by the European Medicines Agency on April 24, 2014.

The approval of this new indication for XTANDI triggers $90 million in milestone payments to Medivation under its collaboration agreement with Astellas.

Note to Editors: 

Enzalutamide Mechanism of Action 

Enzalutamide is an androgen receptor inhibitor that acts on three different steps in the androgen receptor signaling pathway.

About XTANDI^® (enzalutamide)capsules  

XTANDI (enzalutamide) was approved by the FDA on September 10, 2014 for the treatment of patients with metastatic CRPC.

Important Safety Information 

Contraindications: XTANDI (enzalutamide) capsules can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings in animals. XTANDI is not indicated for use in women. XTANDI is contraindicated in women who are or may become pregnant.