IQVIA Real World Capabilities and Expertise Support Path to Label Expansion
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 CORETM, IQVIA is driving innovation within the regulatory environment with its oncology expertise and advanced analytics.
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.