PFE - Astellas and Pfizer's XTANDI gets EMA positive opinion for additional indication

The Committee for Medicinal Products for Human Use ((CHMP)) of the European Medicines Agency ((EMA)) has adopted a positive opinion on an additional indication for Astellas Pharma (ALPMY) and Pfizer's (PFE) XTANDI treatment for adult men with metastatic hormone-sensitive prostate cancer.Astellas shares up more than 5% premarket, while Pfizer shares up marginally.The CHMP decision is based on data from the pivotal Phase 3 ARCHES trial investigating enzalutamide in men with mHSPC, where enzalutamide plus androgen deprivation therapy ((ADT)) significantly reduced the risk of radiographic progression or death by 61% versus placebo plus ADT in men with the condition (n=1,150; hazard ratio [HR]=0.39 [95% confidence interval ((CI)): 0.30-0.50]; P<0.0001).Men diagnosed with mHSPC tend to have a poor prognosis, with a median survival of approximately 3-4 years, underscoring the need for new treatment options, Astellas said.If approved by the European Commission ((EC)), enzalutamide will be the only oral treatment approved by the EC to treat three distinct types of advanced

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Astellas and Pfizer's XTANDI gets EMA positive opinion for additional indication