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Pfizer Submits Palbociclib Marketing Application to the FDA

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Pfizer Inc. (PFE) announced that it has submitted the marketing application for its oncology candidate, palbociclib, to the FDA. The company is looking to get the candidate approved in combination with Novartis’ (NVS) Femara (letrozole) as a first-line treatment in postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received previous systemic treatment for their advanced disease.

The new drug application was filed on the basis of encouraging results from the phase II PALOMA-1 study. Results from study revealed that a combination treatment of palbociclib and Femara led to a statistically significant improvement in progression-free survival (PFS) versus Femara alone in post-menopausal women with ER+, HER2- locally advanced or metastatic breast cancer.

We remind investors that the FDA granted Breakthrough Therapy designation to palbociclib for breast cancer in Apr 2013 on the basis of interim data from the PALOMA-1 study.

Pfizer is currently conducting two phase III studies on palbociclib (PALOMA-2 and PALOMA-3) for the first-line systemic treatment of women with advanced or metastatic ER+, HER2- breast cancer. PALOMA-2 (study 1008) is evaluating the combination of palbociclib and Femara in the same patient population as PALOMA-1.

PALOMA-3 (study 1023) is evaluating palbociclib plus AstraZeneca’s (AZN) Faslodex (fulvestrant) versus Faslodex plus placebo in women with hormone receptor-positive (HR+), HER2- metastatic breast cancer whose disease has progressed after prior endocrine therapy.

Palbociclib is an important candidate in Pfizer’s pipeline. Potential approval in mid 2015 will be a major boost for the company.

Pfizer carries a Zacks Rank #3 (Hold). Some better-ranked health care stocks include Gilead Sciences Inc. (GILD). The stock carries a Zacks Rank #1 (Strong Buy).

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