EMA to review XTANDI™ (enzalutamide) for mHSPC patients

Astellas Pharma announces acceptance by EMA of a Type II Variation Application for regulatory review for the use of XTANDI™ (enzalutamide) in mHSPC patients

Astellas Pharma has announced the acceptance by the European Medicines Agency (EMA) of a Type II Variation Application for regulatory review for the use of XTANDI™ (enzalutamide) in metastatic hormone-sensitive prostate cancer (mHSPC) patients.

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 authorised for this new indication, following 90 days of assessment.

Enzalutamide is currently approved in Europe for the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC) and adult men with metastatic castration-resistant prostate cancer (mCPRC) in whom chemotherapy is not yet clinically indicated, or following disease progression on or after docetaxel therapy. In the U.S. and Japan enzalutamide is indicated for the treatment of CRPC.

“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 Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Oncology Therapeutic Area Head, Astellas.

“We look forward to the CHMP’s opinion as we continue to address the unmet medical need for men with advanced prostate cancer by providing additional treatment options across the disease continuum.”