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EMA validates MAA for Pfizer’s Ibrance
21 August 2015 • Author: Victoria White
The European Medicines Agency (EMA) has validated for review Pfizer’s Marketing Authorisation 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.”
Ibrance in combination with endocrine therapy improved progression-free survival
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 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.
Ibrance is an oral, first-in-class inhibitor of cyclin-dependent kinases (CDKs) 4 and 6. CDKs 4 and 6 are key regulators of the cell cycle that trigger cellular progression.
Ibrance was approved by the US FDA in February 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.
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