EMA accepts variation application for use of Xtandi

The European Medicines Agency (EMA) has accepted a Type II Variation Application for regulatory review for the use of Xtandi (enzalutamide) in metastatic hormone-sensitive prostate cancer (mHSPC) patients, submitted by Astellas Pharma (TYO: 4503), the Japanese drugmaker announced today.

Assessment by the EMA means the Committee for Medicinal Products for Human Use (CHMP) will evaluate the Type II Variation Application for enzalutamide and provide a scientific opinion on whether the medicine may be authorized for this new indication, following 90 days of assessment.

“When prostate cancer begins to spread to other parts of the body, it can be an acutely distressing time for patients. As well as the emotional burden this places on them, daily life can be impacted by debilitating symptoms of progressing cancer, such as pain,” said Dr Andrew Krivoshik, senior vice president and oncology therapeutic area head, Astellas.