FDA and Flatiron Health collaborate on cancer research
Flatiron Health and the U.S. Food and Drug Administration have signed a research collaboration agreement. Together, the oncology company and the government agency will work 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.
As part of the initiative, Flatiron and the FDA are joining forces on a project to investigate the use of immunotherapies in patients with advanced non-small cell lung cancer. They will explore analytic approaches, clinically relevant endpoints and safety assessment methods using real-world evidence.
Flatiron Health and the Center for Drug Evaluation and Research within the FDA will systematically explore the characteristics and treatment patterns of patients with non-small cell lung cancer who are receiving immunotherapy to better understand real-world treatment patterns and formulate further regulatory science hypotheses.
“With only 4 percent of the adult U.S. cancer population enrolled in clinical trials, providers are currently limited to making clinical decisions based upon study results that represent only a small number of patients,” Flatiron chief medical officer Amy Abernethy, MD, said in a statement. “This makes it nearly impossible to estimate whether a treatment will work, anticipate all the potential side effects of therapies or even decide which treatment should precede another.”
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, according to the American Cancer Society.
Flatiron earlier this year raised $175 million to build out its OncologyCloud platform and part of that deal involved also working with Roche, which led the investment round, to advance clinical research.