Posted by Michael Wonder on 20 Aug 2015
Pfizer announces European Medicines Agency validates marketing authorisation application for Ibrance (palbociclib) in combination with endocrine therapy for the treatment of HR+/HER2- metastatic breast cancer
20 August 2015 - Pfizer Inc. today announced that the European Medicines Agency (EMA) has validated for review the 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.”
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.
