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Pfizer Announces European Medicines Agency Validates Marketing Authorization Application for IBRANCE® (palbociclib) in Combination with Endocrine Therapy for the Treatment of [...]

"The MAA for IBRANCE is based on the results from the PALOMA-1 and PALOMA-3 trials, which demonstrated significant clinical benefit for women with HR+/HER2- advanced or metastatic breast cancer"

NEW YORK--(BUSINESS WIRE)--Pfizer Inc. today announced that the European Medicines Agency (EMA) has validated for review the Marketing Authorization Application (MAA) for IBRANCE® (palbociclib) in combination with endocrine therapy for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer. With this validation, the Pfizer application is complete and the EMA will now begin the review procedure.

"The MAA for IBRANCE is based on the results from the PALOMA-1 and PALOMA-3 trials, which demonstrated significant clinical benefit for women with HR+/HER2- advanced or metastatic breast cancer," said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology. "The acceptance of our application for review by the EMA represents a significant step towards potentially bringing IBRANCE to women with metastatic breast cancer in Europe, and Pfizer looks forward to working with the EMA on the review procedure."

The submission is based on the final results of the PALOMA-1 and PALOMA-3 trials in metastatic breast cancer. Both trials demonstrated that IBRANCE in combination with an endocrine therapy improved progression-free survival (PFS) compared to endocrine therapy alone.

The Phase 3 PALOMA-3 study evaluated IBRANCE in combination with fulvestrant compared to a standard of care, fulvestrant, plus placebo in women with HR+/HER2- metastatic breast cancer whose disease had progressed during or after endocrine therapy. The results were presented as a late-breaker at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO) and published in TheNew England Journal of Medicine in June 2015. The Phase 2 PALOMA-1 study evaluated IBRANCE in combination with letrozole compared to letrozole alone in postmenopausal women with estrogen receptor-positive (ER+)/HER2- locally advanced or metastatic breast cancer who had not received previous systemic treatment for their advanced disease. Results were presented in an oral presentation at the American Association of Cancer Research (AACR) Annual Meeting and published in The Lancet Oncology in 2014.

About IBRANCE® (palbociclib)

IBRANCE is an oral, first-in-class inhibitor of cyclin-dependent kinases (CDKs) 4 and 6.1 CDKs 4 and 6 are key regulators of the cell cycle that trigger cellular progression.2,3

In the European Union, IBRANCE is an investigational agent and has not been approved.

IBRANCE was approved by the U.S. Food and Drug Administration (FDA) in February 2015 for use in combination with letrozole as a treatment for postmenopausal women with ER+/HER2- advanced breast cancer as initial endocrine-based therapy for their metastatic disease.1 The effectiveness of IBRANCE in these patients is based on a study that measured PFS.1 Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. IBRANCE has also received regulatory approval in Albania, Chile and Macau.

IMPORTANT IBRANCE (palbociclib) SAFETY INFORMATION FROM THE U.S. PRESCRIBING INFORMATION

Neutropenia: Neutropenia is frequently reported with IBRANCE therapy. In the randomized phase II study, Grade 3 (57%) or 4 (5%) decreased neutrophil counts were reported in patients receiving IBRANCE plus letrozole. Febrile neutropenia can occur.

Monitor complete blood count prior to starting IBRANCE and at the beginning of each cycle, as well as Day 14 of the first two cycles, and as clinically indicated. For patients who experience Grade 3 neutropenia, consider...


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