The FINANCIAL — Pfizer Inc. on September 16 announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that IBRANCE (palbociclib) be granted marketing authorization in the European Union (EU) for the treatment of women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced or metastatic breast cancer.
The CHMP’s positive opinion is for IBRANCE to be used in combination with an aromatase inhibitor, as well as in combination with fulvestrant in women who have received prior endocrine therapy. The CHMP’s opinion will now be reviewed by the European Commission (EC).
If approved, IBRANCE would be the first medicine in a new class of anti-cancer treatments, cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors, to be approved by the EC, according to Pfizer.
“Today’s opinion by the CHMP to recommend marketing authorization of IBRANCE in the EU is an important step toward expanding treatment options for women in Europe with HR+/HER2- metastatic breast cancer, and a step toward a potential new standard of care for this cancer,” said Mace Rothenberg, M.D., chief development officer, Pfizer Oncology. “The opinion is supported by robust data with consistent results observed across three separate randomized trials in which the addition of IBRANCE to standard endocrine therapy resulted in significant prolongation of progression-free survival compared to endocrine therapy alone.”
“There have been only modest improvements in the prognosis of patients with metastatic breast cancer in Europe over the past three decades, underscoring the need for new treatment advances,” said Andreas Penk, M.D., regional president, International Developed Markets, Pfizer Oncology. “We look forward to working with the EC as they conduct their review, with the goal of bringing this first-in-class medicine to appropriate patients across the EU.”
Breast cancer is the most common invasive cancer among women in Europe, with more than 464,200 new cases and 131,260 deaths per year.1 Up to 30 percent of women diagnosed with and treated for early breast cancer will go on to develop metastatic breast cancer which occurs when the cancer spreads beyond the breast to other parts of the body. There is no cure for metastatic breast cancer,5 and patients are in need of new treatment options that help keep their cancer from worsening, manage symptoms and help them maintain quality of life for as long as possible.
Pfizer announced last year that the EMA validated for review the Marketing Authorization Application (MAA) for IBRANCE, which was submitted based on final results from the Phase 2 PALOMA-1 and Phase 3 PALOMA-3 trials. These studies demonstrated that IBRANCE in combination with an endocrine therapy improved progression-free survival (PFS) compared to the endocrine therapy alone or with placebo in certain patients with HR+/HER2- metastatic breast cancer. Results from a separate Phase 3 trial, PALOMA-2, conducted in the same patient population as the Phase 2 PALOMA-1 trial, also demonstrated an improvement in PFS and were added during the MAA review.
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