Astellas Submits MAA For XTANDI For Prostate Cancer
Astellas Pharma announced its submission of a variation to modify the Marketing Authorization Application for XTANDI (enzalutamide) capsules for chemotherapy-naïve metastatic prostate cancer.
The company said that it submitted an MAA together with ally Medivation for XTANDI for the treatment of adult men with metastatic castration-resistant prostate cancer (mCRPC) and who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy and in whom chemotherapy is not yet clinically indicated.
Dr. Ayad Abdulahad, SVP of Medical Affairs & Health Economics at Astellas Pharma Europe Ltd., said, “Oncology is a growing area of focus for Astellas, and we are committed to developing and bringing to market medicines which meet current unmet medical needs. We will continue to work with our partner, Medivation, to seek the necessary European regulatory approval for Xtandi that will allow for its use amongst patients who have not received chemotherapy for their advanced prostate cancer.”
Prostate cancer is the most common cancer in male patients in Europe and is responsible for more than 20 percent of all cancer diagnoses excluding non-melanoma skin cancer. It is also the third most common cause of cancer-related death in Europe. Up to 40 percent of men with prostate cancer develop metastatic disease with a significant percentage eventually failing androgen deprivation treatment, called castration-resistant prostate cancer (CRPC).
Enzalutamide (brand name XTANDI) is a new oral once-daily androgen receptor signaling inhibitor. The drug targets androgen receptors and exerts effects on all three steps of the AR signaling pathway. Xtandi is currently approved in Europe for the treatment of adult men with mCRPC whose cancer has progressed on or following docetaxel chemotherapy.
The announcement comes after the company’s presentation of Phase III data for the PREVAIL trial at the American Society of Clinical Oncology (ASCO) 2014 Genitourinary (GU) Cancers Symposium in San Francisco last January.