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www.fdanews.com/articles/207751-pfizer-offers-real-world-data-on-ibrance-in-metastatic-breast-cancer

Pfizer Offers Real-World Data on Ibrance in Metastatic Breast Cancer

May 10, 2022

Pfizer has released real-world data supporting the efficacy of its kinase inhibitor drug Ibrance (palbociclib) in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer.

The retrospective study demonstrated that, in 2,888 participants, Ibrance combined with an estrogen-lowering aromatase inhibitor led to significant improvements in overall survival compared with the group that received the aromatase inhibitor alone. The study analyzed data from postmenopausal women and men with HR-positive, HER2-negative metastatic breast cancer who were being treated in routine clinical practice in the U.S.

Ibrance gained accelerated approval from the FDA in February 2015 in combination with letrozole for the treatment of HR-positive, HER2-negative advanced breast cancer as initial endocrine-based therapy in postmenopausal women.

A year later, the agency approved the drug in combination with fulvestrant for the treatment of women with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.

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