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FDA Expands Use Of Metastatic Breast Cancer Treatment To Include Male Patients

Pfizer (PFE) said that the U.S. Food and Drug Administration approved a supplemental New Drug Application or sNDA to expand the indications for IBRANCE or palbociclib in combination with an aromatase inhibitor or fulvestrant to include men with hormone receptor-positive or HR+, human epidermal growth factor receptor 2-negative or HER2- advanced or metastatic breast cancer.

The approval is based on data from electronic health records and postmarketing reports of the real-world use of IBRANCE in male patients sourced from three databases: IQVIA Insurance database, Flatiron Health Breast Cancer database and the Pfizer global safety database.

IBRANCE is now approved for adult patients with HR+, HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women or in men; or with fulvestrant in patients with disease progression following endocrine therapy.

With today's approval, IBRANCE is the first and only CDK 4/6 inhibitor indicated in combination with an aromatase inhibitor for the first-line treatment of men with HR+, HER2- metastatic breast cancer in the U.S.

Due to the rarity of breast cancer in males, fewer clinical trials are conducted that include men resulting in fewer approved treatment options. In the U.S. in 2019, it is estimated that there will be 2,670 new cases of invasive breast cancer and about 500 deaths from metastatic breast cancer in males.

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