Regulatory Agency Perspective

Posted: December 2018 Investigators at the National Cancer Institute (NCI) compared the transcriptional profiles of lung cancers from African American patients to those from white patients and identified molecular differences that may result in population differences in tumor biology. Researchers led by Brid M. Ryan, PhD, MPH, an investigator from the Laboratory of Human Carcinogenesis…

Posted: August 2018 In October 2017, the United States National Cancer Institute (NCI) launched a major effort to expand the discovery and validation of predictive biomarkers on cancer immunotherapy. This $56.3-million NCI initiative is part of the U.S. Cancer Moonshot, launched by former President Barack Obama and Vice President Joe Biden and funded by the…

By Erik MacLaren, PhD Posted: August 2018 The National Cancer Institute (NCI) and researchers who rely on the funding it provides have spent much of the past year under the shadow of expected cuts in federal funding. President Trump’s budget request last year proposed cutting the National Institutes of Health (NIH) budget overall by $7.7…

By Leah Christl, PhD, Associate Director for Therapeutic Biologics and Director of the Therapeutic Biologics and Biosimilars Staff, Center for Drug Evaluation and Research, FDA Posted: June 2018 All FDA-approved biologics, including reference and biosimilar products, undergo a thorough evaluation so that patients can be assured of the efficacy, safety, and quality of these products.…

(Photo: Gideon Blumenthal, MD, Nicole Drezner, MD, Mark G. Kris, MD) By Erik J. MacLaren, PhD Posted: February 2018 The development of immunotherapies and targeted therapies for use in lung cancers has provided less-toxic options for treating these malignancies. Researchers have begun investigating the possibility of using these newer drugs in the neoadjuvant setting, that is,…

Posted: December 2017 Patients with completely resected early-stage non-small cell lung cancer (NSCLC) have approximately a 50% chance of experiencing disease recurrence following standard treatment. In 2014, the NCI initiated a group of randomized clinical trials, called the Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials (ALCHEMIST), to test adjuvant treatments to prevent cancer…

Posted: December 2017 The Information Exchange and Data Transformation (INFORMED) initiative was launched by the U.S. Food and Drug Administration (FDA) and the Innovation, Design, Entrepreneurship and Action (IDEA) Lab of the U.S. Department of Health and Human Services. INFORMED is intended to promote the use of big data analytics to analyze the large and…

By Erik J. MacLaren, PhD Posted: October 2017 On July 28, 2017, the U.S. Food and Drug Administration (FDA) announced a new, multi-year strategy intended to reduce tobacco-related disease and mortality. As part of this new strategy, the agency will begin developing a plan to reduce nicotine in combustible cigarettes to non-addictive levels and delay…

By Erik J. MacLaren, PhD Posted: October 2017 Scott Gottlieb, MD, Commissioner of the U.S. Food and Drug Administration, said in a recent speech, “There’s probably no single intervention or product we’re likely to create in the near future that can have as profound an impact on reducing illness and death from disease as our…

NCI Helping to Save Lives and Improve Cancer Survival Rates Scientific data from clinical trials are essential for evaluating new cancer treatments and setting new standards of care for patients. The National Cancer Institute (NCI) has supported clinical trials for over 50 years through the Cooperative Group Program, which has produced many important improvements in…