Flatiron Health and the FDA Embark on Cancer Research Collaboration

NEW YORK–(BUSINESS WIRE)– Flatiron Health and the U.S. Food and Drug Administration (FDA) have
signed a research collaboration agreement to determine how real-world
evidence derived from de-identified, HIPAA-compliant patient data
captured outside of clinical trials can provide new insights into the
safety and effectiveness of emerging anti-cancer therapies such as
immunotherapeutic agents.

As part of this research initiative, Flatiron Health and the FDA are
collaborating on a project to investigate the use of immunotherapies in
patients with advanced non-small cell lung cancer (aNSCLC). Flatiron
Health and the FDA will use this project to explore analytic approaches,
clinically-relevant endpoints and safety assessment methods using
real-world evidence.

“With only four percent of the adult U.S. cancer population enrolled in
clinical trials, we as providers are currently limited to making
clinical decisions based upon study results that represent only a small
number of patients. This makes it nearly impossible to estimate whether
a treatment will work, anticipate all of the potential side effects of
therapies or even decide which treatment should precede another,” said
Amy Abernethy, chief medical officer and senior vice president,
Oncology, Flatiron Health. “Collaborative projects such as this one with
the FDA allow us to access real-world evidence for more accurate and
actionable insights into patient care and expected outcomes outside of
clinical trials, supporting the delivery of high quality patient care.”

Lung cancer is the leading cause of cancer deaths in the United States,
with more than 220,000 new cases and approximately 160,000 deaths in
2015.¹ In recent years, immunotherapy – a novel class of
therapies that leverage the body’s own immune system to help fight
cancer – has emerged as a promising approach in the treatment of aNSCLC.
Under the collaboration, Flatiron Health and the Center for Drug
Evaluation and Research (CDER) within the FDA will systematically
explore the characteristics and treatment patterns of patients with
aNSCLC who are receiving immunotherapy to better understand real-world
treatment patterns and formulate further regulatory science hypotheses.

About Flatiron Health, Inc.

Flatiron Health helps the oncology community deliver better, more
efficient care by powering an innovative platform to address today’s
healthcare challenges. The Flatiron Health OncologyCloud™ platform
includes the industry-leading electronic medical record for oncology,
advanced analytics, patient portal and integrated billing management.
Backed by Google Ventures, First Round Capital, Roche and others,
Flatiron’s industry-first technology platform and integrated suite of
products deliver comprehensive support for cancer care providers and
life science companies. For more information, please visit www.flatiron.com.

¹ American Cancer Society. Cancer Facts & Figures 2015. Atlanta:
American Cancer Society; 2015.

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