Pfizer to submit NDA for palbociclib

NEW YORK — Pfizer announced plans to submit a new drug application with the Food and Drug Administration for palbociclib (combined with letrozole). The drug is used for the first-line systemic treatment of post-menopausal women with advanced or metastatic breast cancer.

The company said it plans to submit the NDA early in third quarter 2014. The decision to file was based on discussions with the FDA surrounding the final results of a randomized, Phase 2 trial called PALOMA-1.

 

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