The European Commission (EC) has approved palbociclib (marketed by Pfizer as Ibrance) 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 approval is for palbociclib to be used in combination with an aromatase inhibitor.
The approval also covers the use of palbociclib in combination with fulvestrant in women who have received prior endocrine therapy.
Palbociclib is the first medicine to be approved in Europe that works by inhibiting cyclin-dependent kinases 4 and 6 (CDK 4/6).
It also is the first new medicine approved for the treatment of women with this type of metastatic breast cancer in the first-line setting in nearly 10 years.
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.
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.
Women with HR /HER2- metastatic breast cancer represent about 60 percent of all metastatic breast cancer cases.
There is no cure for metastatic breast cancer, 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.
The EC approval is based on a robust submission package including results from the Phase 2 PALOMA-1 trial in postmenopausal women with estrogen receptor-positive (ER )/HER2- metastatic breast cancer who had not received prior systemic therapy for their advanced disease, the Phase 3 PALOMA-2 trial in the same population and the Phase 3 PALOMA-3 trial in women with HR /HER2- metastatic breast cancer who had progressed on prior endocrine therapy.
All three randomised trials demonstrated that palbociclib in combination with an endocrine therapy significantly prolonged progression-free survival (PFS) compared to endocrine therapy alone or endocrine therapy with placebo.
“Palbociclib is an exciting advance in the management of women with hormone receptor-positive breast cancer. Patients with this type of breast cancer are usually treated with hormone therapy but many will progress or relapse – and as a result require chemotherapy, which often comes with life-limiting side-effects,” said Nicholas Turner, M.D., Ph.D., team leader at The Institute of Cancer Research, London, and consultant medical oncologist at The Royal Marsden NHS Foundation Trust, as well as principal investigator of the PALOMA-3 trial. “Palbociclib, when used in combination with standard hormone therapy, increases the duration of tumour control and is well tolerated by most women – and could delay the need for women with this type of advanced breast cancer to start chemotherapy.”
“Metastatic breast cancer patients in Europe need new treatment options available to them,” said Kathi Apostolidis, two-time breast cancer survivor and vice president of the European Cancer Patient Coalition. “Metastatic breast cancer places a heavy burden on cancer patients and their families, but patients hope that novel treatments may have the potential to provide better quality of life and outcomes.”
“Today’s approval of palbociclib in the European Union (EU) brings an innovative and much-needed new treatment option to tens of thousands of women with HR /HER2- metastatic breast cancer,” said Andreas Penk, M.D., regional president, International Developed Markets, Pfizer Oncology. “With strong and consistent data in three pivotal clinical studies and rapid adoption as a standard of care in the U.S., palbociclib represents a potential new benchmark for the treatment of HR /HER2- metastatic breast cancer in Europe.”
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