Pfizer’s new breast cancer drug Ibrance accepted for EU review

Pfizer has announced that its new breast cancer drug Ibrance has been accepted for European regulatory review.

The European Medicines Agency (EMA) has validated the firm's marketing authorisation application for Ibrance in combination with endocrine therapy for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer.

This submission is based on the final results from the PALOMA-1 and PALOMA-3 trials in metastatic breast cancer, both of which demonstrated that Ibrance, used in combination with an endocrine therapy, improved progression-free survival compared to endocrine therapy alone.

Ibrance was previously approved by the US Food and Drug Administration in February this year.

Dr Mace Rothenberg, senior vice-president of clinical development and medical affairs and chief medical officer for Pfizer Oncology, said: "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."

The firm is in the process of completing its acquisition of Hospira, having received European approval for the deal earlier this month.