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IQVIA Real World Capabilities and Expertise Support Path to Label Expansion

May 30, 2019 Off By BusinessWire

Previously announced FDA approval of IBRANCE^®
(palbociclib) for the treatment of men with metastatic breast cancer
based in part on IQVIA real world analytics; Pfizer Oncology to present
analysis at ASCO

DANBURY, Conn. & RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–IQVIA™
(NYSE:IQV) is pleased to have provided support towards the approval from
the U.S. Food and Drug Administration to expand the indications for
IBRANCE® (palbociclib) in combination with an aromatase inhibitor or
fulvestrant to include the treatment of men with hormone
receptor-positive (HR+), human epidermal growth factor receptor
2-negative (HER2-) advanced or metastatic breast cancer. Pfizer Oncology
will present the results as a poster at the upcoming 2019 American
Society of Clinical Oncology (ASCO) Annual Meeting, May 31 to June 4 in
Chicago, Illinois.

Pfizer Oncology’s IBRANCE is indicated for the treatment of 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. IQVIA
delivered deep analytics to support Pfizer’s submission which led to the
expanded approval. The use of IQVIA’s innovative approach helped enable
Pfizer Oncology to offer IBRANCE as a treatment option for this
underserved patient population where, due to the rarity of the disease,
fewer large, randomized clinical trials are conducted.

IQVIA is at the forefront of using advanced real world capabilities for
regulatory requirements – combining sophisticated analytics, access to a
global network of providers, and deep clinical expertise to deliver
innovative study designs. Powered by the IQVIA CORE^TM, IQVIA
is driving innovation within the regulatory environment with its
oncology expertise and advanced analytics.

About IQVIA

IQVIA (NYSE:IQV) is a leading global provider of advanced analytics,
technology solutions and contract research services to the life sciences
industry. Formed through the merger of IMS Health and Quintiles, IQVIA
applies human data science — leveraging the analytic rigor and clarity
of data science to the ever-expanding scope of human science — to enable
companies to reimagine and develop new approaches to clinical
development and commercialization, speed innovation and accelerate
improvements in healthcare outcomes. Powered by the IQVIA CORE™, IQVIA
delivers unique and actionable insights at the intersection of
large-scale analytics, transformative technology and extensive domain
expertise, as well as execution capabilities. With more than 58,000
employees, IQVIA conducts operations in more than 100 countries.

IQVIA is a global leader in protecting individual patient privacy. The
company uses a wide variety of privacy-enhancing technologies and
safeguards to protect individual privacy while generating and analyzing
information on a scale that helps healthcare stakeholders identify
disease patterns and correlate with the precise treatment path and
therapy needed for better outcomes. IQVIA’s insights and execution
capabilities help biotech, medical device and pharmaceutical companies,
medical researchers, government agencies, payers and other healthcare
stakeholders tap into a deeper understanding of diseases, human
behaviors and scientific advances, in an effort to advance their path
toward cures. To learn more, visit www.iqvia.com.

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