Pfizer Gets Palbociclib To NDA Finish Line On Phase II Data
This article was originally published in The Pink Sheet Daily
Executive Summary
Pfizer finished a rolling NDA for the high-profile breast cancer drug, the first-in-class CDK-4/6 inhibitor. Whether or not FDA will agree Phase II data results from the PALOMA-1 trial are sufficient to grant accelerated approval remains to be seen.
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