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Pfizer Gets Palbociclib To NDA Finish Line On Phase II Data

 
• By Jessica Merrill

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.

Pfizer Inc. has completed the rolling NDA submission for its high-profile breast cancer treatment palbociclib, positioning the drug for a potential approval in the first half of 2015 – but it remains to be seen whether FDA grants an accelerated approval based on limited Phase II data in a relatively well-served setting.

Pfizer announced it completed the filing Aug. 18. The company is seeking approval of palbociclib in combination with the aromatase...

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• By Natasha Barrow

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