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Pfizer Gets Palbociclib To NDA Finish Line On Phase II Data

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Pfizer finished a rolling NDA for the high-profile breast cancer drug, the first-in-class CDK-4/6 inhibitor. Whether 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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