Pfizer Inc. (NYSE:PFE) today announced the publication of the - TopicsExpress

Pfizer Inc. (NYSE:PFE) today announced the publication of the detailed results from PALOMA-1, a randomized Phase 2 study of palbociclib in combination with letrozole versus letrozole alone, in The Lancet Oncology. As previously disclosed, PALOMA-1 achieved its primary endpoint with the combination of palbociclib and letrozole significantly prolonging progression-free survival (PFS) compared with letrozole alone in post-menopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer.Related Biotechnology, Pharmaceutical and Healthcare NewsPfizer reports positive Phase II PALOMA-1 trial of palbociclibPfizer completes palbociclib NDA submissionPriority Review for Pfizers palbociclibPfizer Gets Palbociclib To NDA Finish Line On Phase II DataPfizer: Breast Cancer Treatment ResultsA New Drug Application (NDA) for palbociclib was accepted for filing and granted Priority Review by the United States Food and Drug Administration (FDA). This NDA is based on the final results of PALOMA-1. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is April 13, 2015. IBRANCETM is the proposed trade name for palbociclib.“The publication of the PALOMA-1 data in The Lancet Oncology marks another important milestone in the path to bring IBRANCETM, the proposed trade name for palbociclib, to women with ER+, HER2- metastatic breast cancer, who haven’t seen a first-line treatment advance in more than 10 years,” said Dr. Mace Rothenberg, Senior Vice President of Clinical Development and Medical Affairs and Chief Medical Officer for Pfizer Oncology.Results from PALOMA-1 were presented by lead author Dr. Richard Finn at the American Association for Cancer Research (AACR) Annual Meeting 2014. PALOMA-1 was conducted in collaboration with the Jonsson Comprehensive Cancer Center’s Revlon/UCLA Women’s Cancer Research Program, led by Dr. Dennis Slamon.

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