Pfizer, Astellas win priority review for Xtandi sNDA; Hemispherx changes its name
→ The FDA has granted Pfizer $PFE and Astellas priority review for a label expansion for Xtandi, the prostate cancer drug it grabbed in the $14 billion acquisition of Medivation. An approval here, for metastatic hormone-sensitive prostate cancer, would make the drug available to patients earlier in their treatment regimen, the companies said. In two Phase III studies, the drug was shown to improve progression-free survival when used in conjunction with androgen deprivation therapy.
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