Newswire (Published: Saturday, July 27, 2019, 5:31:00 AM CDT, Received: Saturday, July 27, 2019, 5:58:40 AM CDT)

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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 CHMPs 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.

Companies

Astellas Pharma Inc.
Astellas Pharma Inc.
European Medicines Agency

Places

Eastern Asia
North America
Japan
United States
Americas
Asia
Europe

Subjects

Health and Wellness
      Medical Conditions and Diseases
            Cancer
                  Prostate Cancer
            Men's Health Issues
                  Prostate Cancer
      Medical and Pharmaceutical Regulation
            Drug and Device Approval Process
                  Non-US Drug and Device Approval
      Treatments and Therapies
Trading Impact
      Drug and Device Regulatory Impact
            Non-US Drug and Device Approval
Politics and Government
      Government Regulation