Reuters

(Reuters)

Pfizer to Submit New Application for Breast Cancer Drug

By Health Care FOXBusiness

Pfizer (PFE) said Friday it will submit a new drug application for its experimental breast cancer drug, palbociclib.

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The decision, which it made after holding discussions with the U.S. Food and Drug Administration, followed the receipt of interim results of a mid-stage study.

In that study, the drug was paired with existing breast cancer drug letrozole. The two were then compared against letrozole alone.

The largest U.S. drugmaker expects to submit a new drug application for palbociclib early in the third quarter of this year. This comes about a year after the drug giant received breakthrough therapy designation for palbociclib from the FDA in April 2013.

The drug, an oral targeted agent, is being investigated as a treatment of locally advanced or metastatic breast cancer in post-menopausal women.

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