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Pfizer Inc. (PFE) Release: Palbociclib Expanded Access Program Now Open To Eligible U.S. Patients With Hr+, Her2- Advanced Breast Cancer



8/21/2014 10:20:32 AM

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NEW YORK--(BUSINESS WIRE)--Pfizer Inc. today announced that the company has initiated a multi-center, open-label expanded access program (EAP) in the United States for the investigational CDK 4/6 inhibitor, palbociclib. Through the program, palbociclib is being made available for use in combination with letrozole for post-menopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer for whom letrozole is considered appropriate therapy. Healthcare professionals and patients can learn more about the palbociclib EAP by visiting www.clinicaltrials.gov (trial number: NCT02142868).

Under its expanded access programs, the U.S. Food and Drug Administration (FDA) works with companies to allow access to investigational therapies to patients with serious or life-threatening illnesses who do not otherwise qualify for participation in a clinical trial and for whom there are no comparable or satisfactory alternate therapies.

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