Pfizer awarded approval for IBRANCE for treating women with HR+/HER2- metastatic breast cancer in the EU.
M2 PHARMA-November 10, 2016-Pfizer awarded approval for IBRANCE for treating women with HR+/HER2- metastatic breast cancer in the EU
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Healthcare company Pfizer (NYSE:PFE) reported on Wednesday the receipt of approval from the European Commission (EC) for IBRANCE (palbociclib) for the treatment of women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced or metastatic breast cancer.
This EC approval, which covers the use of the company's IBRANCE in combination with fulvestrant in women who have received prior endocrine therapy, is to be used in combination with an aromatase inhibitor. IBRANCE is an oral inhibitor of cyclin-dependent kinases that are regulators of the cell cycle that trigger cellular progression.
The company said IBRANCE is the first medicine to be approved in Europe that works by inhibiting cyclin-dependent kinases 4 and 6 (CDK 4/6). It 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 ten years.
According to the company, 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 IBRANCE in combination with an endocrine therapy significantly prolonged progression-free survival (PFS) compared to endocrine therapy alone or endocrine therapy with placebo, concluded the company.
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|Date:||Nov 10, 2016|
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