Enzalutamide Use Before Chemo Recommended in Europe

Roxanne Nelson

October 24, 2014

The Committee for Medicinal Products for Human Use (CHMP) in Europe has recommended an extension of the use of enzalutamide (Xtandi, Astellas Pharma Europe Ltd) in the treatment of prostate cancer.

The new indication that was recommended for approval is used in "the treatment of adult men with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated."

This is similar to the new indication that has been approved in the United States.

This indication widens the use of the drug and allows it to be used at an earlier stage of the disease; previously enzalutamide was indicated for use in mCRPC only among patients who had already tried chemotherapy with docetaxel. It received marketing authorization for this use by the European Commission in June 2013 and has been available in the United States since August 2012.

Enzalutamide is the first "once-a-day" oral drug that doesn't require concomitant steroids, and has been described as a "game changer" in the treatment of prostate cancer.

The positive CHMP opinion for the new indication of use before chemotherapy is based on results from the phase 3 PREVAIL study, which showed that patients receiving enzalutamide demonstrated a statistically significant reduction in the risk for death and radiographic progression as compared with placebo treatment.

"Enzalutamide marks a significant step for many patients who live with mCRPC as encouraging, it demonstrates benefits in overall survival, has a positive impact on quality of life and has been shown to be well tolerated," said Bertrand Tombal, MD, PhD, chairman of the Division of the Urology and professor of Physiology, Université Catholique de Louvain, Belgium, and European principal investigator for PREVAIL, in a statement.


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