Astellas Receives Positive CHMP Opinion for XTANDI™ in Additional Recurrent Early Prostate Cancer Treatment Setting [Yahoo! Finance]
ASTELLAS PHARMA UNSP/ADR (ALPMY)
NASDAQ:AMEX Investor Relations:
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Source: Yahoo! Finance
- A decision on the EU marketing authorisation is expected by June 2024 TOKYO March 22, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura , "Astellas") today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of XTANDI™ (enzalutamide) as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high risk biochemical recurrent (BCR) non-metastatic hormone sensitive prostate cancer (nmHSPC) who are unsuitable for salvage radiotherapy. Ahsan Arozullah, MD, MPH, Senior Vice President and Head of Oncology Development, Astellas "Men with nmHSPC with high-risk biochemical recurrence are very likely to experience disease progression. With approximately 9 out of 10 of these men developing metastatic disease, the need for new and effective treatment options is critical. Today's positive opinion from the Commi
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