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Increasing Use of Real-World Data to Help Improve Cancer Care

In April 2019,Ibrance® (palbociclib) was approved for men with HR+, HER2- metastatic breast cancer. While the U.S. Food and Drug Administration’s (FDA) decision was based largely on prior efficacy data from randomized controlled studies in women with metastatic breast cancer, such as the PALOMA-2 trial, Pfizer’s supplemental regulatory submission for male breast cancer primarily included real-world evidence.

Male breast cancer represents <1% of breast cancer cases, making trials and research surrounding treatment difficult. Pfizer engagedFlatiron Health to explore real-world data from post-marketing reports, Flatiron’s breast cancer database, electronic health records from IQVIA Insurance, Pfizer’s global safety database and controlled studies in women to make the case to the FDA that Ibrance could be used to treat men.

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