EMA validates Pfizer’s MAA for breast cancer combination treatment

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

With the validation of Pfizer’s MAA complete, the EMA will now start the review procedure.

The MAA is based on the final results of the PALOMA-1 and PALOMA-3 trials in metastatic breast cancer, which showed that Ibrance in combination with an endocrine therapy improved progression-free survival (PFS) compared to endocrine therapy alone.

Pfizer Oncology Clinical Development and Medical Affairs senior vice-president and chief medical officer Dr Mace Rothenberg said: "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.

"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 Phase III PALOMA-3 trial 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 II PALOMA-1 trial 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.

Image: Pfizer world headquarters. Photo: courtesy of Jim.henderson.