Pfizer said the U.S. FDA accepted for Priority Review a supplemental NDA for TALZENNA (talazoparib) combined with XTANDI (enzalutamide) for men with metastatic castration-sensitive prostate cancer (mCSPC). Priority Review acceptance is a positive regulatory milestone, which can support a faster path to potential label expansion.
Pfizer said the U.S. FDA accepted for Priority Review a supplemental NDA for TALZENNA (talazoparib) combined with XTANDI (enzalutamide) for men with metastatic castration-sensitive prostate cancer (mCSPC). Priority Review acceptance is a positive regulatory milestone, which can support a faster path to potential label expansion.
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