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news.Pfizer has secured approval from the European Commission (EC) for Ibrance (palbociclib) to treat women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced or metastatic breast cancer.
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The approval allows the company to use Ibrance in combination with an aromatase inhibitor.
It also allows the use of Ibrance in combination with fulvestrant to treat women who have received endocrine therapy previously.
The drug is now the first medicine based on inhibiting cyclin-dependent kinases 4 and 6 (CDK 4/6) to be approved in the continent.
Pfizer Oncology International Developed Markets regional president Andreas Penk said that the EC approval has led to an innovative and much-needed new treatment option to tens of thousands of HR+/HER2- metastatic breast cancer patients.
Penk added: “With strong and consistent data in three pivotal clinical studies and rapid adoption as a standard of care in the U.S., IBRANCE represents a potential new benchmark for the treatment of HR+/HER2- metastatic breast cancer in Europe.”
The EC approval was based on results of the three randomized trials that showed Ibrance in combination with an endocrine therapy stretched the progression-free survival of a patient significantly in comparison to only endocrine therapy or endocrine therapy in combination with placebo.
Ibrance is an oral inhibitor of cyclin-dependent kinases 4 and 6, which are key regulators of the cell cycle that trigger cellular progression.
The drug is now approved in over 50 countries. It is indicated in the US to treat HR+, HER2- advanced or metastatic breast cancer in combination with letrozole as initial endocrine based therapy in postmenopausal women, or fulvestrant in women with disease progression following endocrine therapy.