The FINANCIAL — Pfizer Inc. on August 20 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, according to Pfizer.
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 The New 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.
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