Cancer Policy Monitor: August 9, 2022
- President Biden Names AACR Past President Elizabeth M. Jaffee, MD Chair of the President’s Cancer Panel
- Register for the Rally for Medical Research!
- Apply to the Third Class of FDA-AACR Oncology Educational Fellows
- REGISTER NOW: The Virtual AACR Patient Advocate Forum On The Transformative Potential Of Cancer Biomarkers
- AACR Submits Comments to FDA Supporting Prohibition of Menthol Cigarettes and Flavored Cigars
- View Now: Project Livin’ Label Features Pembrolizumab
- Senate Committee Holds Confirmation Hearing for Arati Prabhakar, PhD to Be Director of the OSTP
- NCI Publishes New Monograph Supporting Smoking Cessation for Patients with Cancer
- The NCI Funding Opportunity Announcement Promotes Collaboration in Cancer Disparity Research
- NCI Seminar Series Highlights Research in Understudied Populations and Cancer Disparities
President Biden Names AACR Past President Elizabeth M. Jaffee, MD Chair of the President’s Cancer Panel
-Tristen Tellman, PhD
This July, AACR Past President, Elizabeth M. Jaffee, MD, was named chair of the President’s Cancer Panel. In this role, Dr. Jaffee will serve alongside experts to advise the president on how to best utilize the resources of the federal government to guide the Reignited Cancer Moonshot. Dr. Jaffee previously served as co-chair of the Blue Ribbon Panel that advised then-Vice President Biden’s original Cancer Moonshot Initiative and is a past chair of the National Cancer Advisory Board. She is the deputy director of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
One of the main components of the Reignited Cancer Moonshot is a call to action to increase cancer screening, an area that has been greatly affected by the recent pandemic, where millions of patients have missed these potentially life-saving appointments. Earlier this year, the AACR published one of the most comprehensive reports on the effects of COVID-19 in cancer. On invitation from the White House, AACR leaders have remained an integral part of the conversation with President Biden in the mission of “improving cancer prevention strategies, increasing cancer screenings and early detection, reducing cancer disparities, and propelling new lifesaving cures for patients with cancer.”
Read more about the AACR’s involvement in the launch of the Reignited Cancer Moonshot.
Register for the Rally for Medical Research!
The 10th Annual Rally for Medical Research will be held on September 13-14, 2022, in Washington, D.C. The rally brings together advocates from around the country to call upon the nation’s policymakers to make the National Institutes of Health a national priority and bring attention to the importance of stable and robust investments in medical research. A participant training and a reception will be held September 13, followed by Rally Hill Day September 14 where participants will meet with congressional representatives.
Register for the rally. Please contact [email protected] with any questions.
Apply to the Third Class of FDA-AACR Oncology Educational Fellows
The AACR-FDA Oncology Educational Fellowship is designed to help cancer researchers and clinicians learn about the regulatory processes and drug development and network with leaders at FDA and AACR. The one-year program is primarily conducted virtually with fellows at their home institutions with didactic lectures, group discussions, and homework assignments. Topics covered by the program will include INDs, NDAs/BLAs, expedited pathways, animal studies, clinical pharmacology, statistics, clinical trial design, companion diagnostics, biomarkers, and precision oncology.
To be eligible, applicants must:
- Be a member of AACR
- Have completed an advanced degree (e.g., MD, PhD, DO, etc.)
- Started their current position within the past five years
For additional information and to apply, please visit the Fellowship Webpage. All application materials must be submitted by 11:59 p.m. ET August 15, 2022.
REGISTER NOW: THE VIRTUAL AACR PATIENT ADVOCATE FORUM ON THE TRANSFORMATIVE POTENTIAL OF CANCER BIOMARKERS
Tuesday, August 23, 2022; 1 – 3:30 p.m. ET/ 10 a.m.- 12:30 p.m. PT
Join the cancer advocacy community Tuesday, August 23, at 1 p.m. ET, for a free virtual AACR Patient Advocate Forum on Cancer Biomarkers. Each person’s cancer has a unique pattern of biomarkers, making biomarker testing a critical part of diagnostics and treatment. This forum will explore where and how biomarkers are changing cancer research and care to benefit patients with cancer. To learn more about the AACR Patient Advocate Forums and register for this forum, please visit the AACR patient advocacy webpages.register now
AACR Submits Comments to FDA Supporting Prohibition of Menthol Cigarettes and Flavored Cigars
-Nicholas Warren, PhD
Tobacco use is the leading modifiable cause of cancer, associated with more than 18 types of cancer. A large body of scientific evidence has shown flavored tobacco products are especially damaging to public health, primarily by increasing the number of youth who start smoking who otherwise would not. Numerous studies demonstrate flavors make tobacco products more appealing to youth and increase the likelihood they will progress to regular smoking. In 2021, 79 percent of youth who regularly used tobacco products used flavored products, with fruit flavors like mango being the most common. Cooling agents, such as menthol, also reduce the irritation from tobacco smoke and further contributes to the greater difficulty of quitting tobacco.
In 2009, the Family Smoking Prevention and Tobacco Control Act (TCA) prohibited most flavors of cigarettes, but exempted menthol cigarettes and flavored cigars. As a consequence, the market share of menthol cigarettes and flavored cigars has increased since 2009 as traditional cigarette sales have declined more steeply; in 2021, more U.S. high school students regularly smoked cigars than those who regularly smoked cigarettes (310,000 vs 280,000 students). This April, the U.S. Food and Drug Administration (FDA) announced two draft rules that would end these exemptions by prohibiting menthol cigarettes and all flavored cigars. The federal rule-making process requires agencies to solicit comments from the public on draft rules, and consider and respond to every unique comment, including cited scientific literature when developing final rules.
In July, the American Association for Cancer Research’s (AACR) Tobacco Products and Cancer Subcommittee submitted a public comment to strongly support both the menthol cigarette and flavored cigar rules. The public comments encouraged FDA to further strengthen the rules by establishing clear limits on the amount of cooling agents allowed in tobacco products and by expanding the cigar rule to all combustible tobacco products. It is concerning that menthol is added to many cigarette and cigar products that are not advertised as having a menthol flavor. The tobacco industry’s own internal communications clearly show menthol is added to increase the appeal and reduce the harshness of tobacco smoke. Additionally, AACR supported expanding the flavored cigar rule to all combustible tobacco products.
If finalized, prohibition of menthol cigarettes and cigars is estimated to prevent 650,000 deaths from tobacco-related illness by 2060. The AACR’s public comments are the latest in a long history of advocating for effective tobacco control policies. See past statements from the Tobacco Products and Cancer Subcommittee. The AACR will continue advocating for policies to eliminate all tobacco-related cancers.
NCI Publishes New Monograph Supporting Smoking Cessation for Patients with Cancer
-Nicholas Warren, PhD
For someone who smokes, quitting smoking is the number one thing they can do to improve their health. This statement holds true even after a cancer diagnosis, it is never too late to quit smoking. This June, the National Cancer Institute (NCI) published a monograph titled “Treating Smoking in Cancer Patients: An Essential Component of Cancer Care,” which details the scientific evidence regarding smoking cessation among patients with cancer. Quitting smoking can improve survival following a cancer diagnosis by up to double compared to continued smoking, which is a similar magnitude of benefit to many anti-cancer therapies. Unfortunately, many patients are not effectively supported with evidence-based counseling and FDA-approved medication following a cancer diagnosis. The report identified many barriers to routine cessation therapy, including: lack of training in treating tobacco use; lack of clinician time related to shortages of healthcare workers; gaps in insurance coverage; psychological distress of receiving a cancer diagnosis; and stigma associated with smoking and cancer.
Fortunately, there are promising examples of effective cessation programs for patients with cancer included in the report. With funding from the 21st Century Cures Act, the NCI’s Cancer Center Cessation Initiative (C3I) has helped establish robust tobacco treatment programs specifically for patients with cancer at 52 cancer centers across the United States. Several C3I leaders were featured at the AACR Annual Meeting this spring during a cessation titled, “Supporting Smoking Cessation Among Patients with Cancer Who Use Tobacco Products,” to highlight the effectiveness of sponsored programs at the University of Wisconsin, Northwestern University, the University of Arizona, and the University of Miami.
The report emphasizes the importance of assessing tobacco use by patients with cancer in all clinical and research settings. Tobacco use assessments varied greatly prior to 2013 when NCI and AACR created a joint task force to standardize best practices for tobacco use assessments and propose questions for future research. The work of the task force culminated in a 2016 Cancer Patient Tobacco Use Questionnaire (C-TUQ) that provides clinicians and researchers with specific advice on how to best document tobacco use.
Future research needs to improve smoking cessation efforts by patients with cancer are also detailed in the report. Most importantly, there is a lack of high-quality randomized clinical trials assessing the efficacy of smoking cessation therapies specifically for patients with cancer. These trials would be key to understanding the most effective methods to help patients quit smoking. Implementation science studies are also needed to assess the most effective designs for cessation services. Additionally, how tobacco smoke affects specific types of cancer and anti-cancer therapies is relatively unknown; more studies are needed to determine if patients with cancer who smoke benefit from different doses of medications or different kinds of medications than patients who do not smoke. AACR is committed to continue working with NCI to help address these ongoing questions and help support smoking cessation for patients with cancer.
Senate Committee Holds Confirmation Hearing for Arati Prabhakar, PhD, to Be Director of the OSTP
-Marc Johnson, MPP
On July 20, the Senate Committee on Commerce, Science, and Transportation held a hearing to consider the nomination of Arati Prabhakar, PhD, to serve as director of the Office of Science and Technology Policy (OSTP). OSTP is charged with ensuring that advances in science and technology improve the health, prosperity, and security of all Americans. OSTP also plays a leading role in coordinating President Biden’s Reignited Cancer Moonshot, and if confirmed, Dr. Prabhakar would work on this important initiative that aims to cut the cancer death rate in half over the next 25 years. Dr. Prabhakar is also a groundbreaking choice to lead OSTP. If confirmed, she would be the first woman, immigrant, and person of color to serve as a Senate-confirmed director of OSTP.
Dr. Prabhakar’s career includes senior-level government positions and experience in the private sector. During the Clinton Administration, Dr. Prabhakar served as director of the National Institute of Standards Technology (NIST), the first woman to hold that position. After her service at NIST, Dr. Prabhakar worked in Silicon Valley as a senior executive and consultant for multiple technology and venture capital companies. Dr. Prabhakar returned to government service in 2012 as director of the Defense Advanced Research Projects Agency (DARPA). Under her leadership, DARPA oversaw a variety of high-risk, high-reward projects and established the Biological Technologies Office.
AACR President Lisa M. Coussens, PhD, FAACR, stated her enthusiastic endorsement of Dr. Prabhakar’s nomination, stating “We are excited about working with Dr. Prabhakar and the talented staff at OSTP to accelerate the pace of discovery research and translational research, and bring benefits of such research to cancer patients everywhere.” Dr. Prabhakar’s nomination is now pending before the U.S. Senate.
The NCI Funding Opportunity Announcement Promotes Collaboration in Cancer Disparity Research
-Calais Prince, PhD
Advancements in cancer research have improved diagnosis, prognosis, and outcomes for patients with cancer. As described in the AACR Cancer Disparities Progress Report 2022: Achieving the Bold Vision of Health Equity for Racial and Ethnic Minorities and Other Underserved Populations and Congressional Briefing, cancer disparities remain among specific populations for various types of cancers. The report also highlighted the progress being made toward cancer health equity and stressed the ongoing need for a multidisciplinary and collaborative approach—including robust federal funding—to address this complex and multifactorial public health issue. An increase in the scope and depth of cancer disparities research, including expansion of the pool of competitive researchers with expertise to conduct cancer disparities research, remains a priority for the NCI and is urgently needed to accelerate the progress in reducing cancer disparities.
A trans-NCI Funding Opportunity Announcement (FOA) seeks to promote new cancer disparities research by encouraging the partnership of experienced investigators with cancer disparities-focused researchers. This FOA is intended to accelerate and strengthen multi-disciplinary cancer disparities research in wide-ranging areas. Cancer disparities research includes, but is not limited to basic, translational, behavioral, observational, interventional, environmental, and population research studies that address the adverse differences in cancer incidence, prevalence, mortality, survivorship, burden, and/or response to treatment in racial and ethnic minorities and underserved population groups. Proposed collaborations should focus on achieving research objectives that rely on diverse and complementary expertise, technical capabilities, and resource sets. Applications will be accepted until September 6, 2022. Biannual due dates occurring during calendar years 2023 and 2024 are January 23 and September 6.
VIEW NOW: PROJECT LIVIN’ LABEL FEATURES PEMBROLIZUMAB
FDA-AACR Project Livin’ Label Initiative – A Session on Pembrolizumab, a Treatment for Patients with Triple Negative Breast Cancer.
Project Livin’ Label is an educational collaboration between the FDA’s Oncology Center of Excellence and the AACR. The goal of this program is to help health care providers and patients become more familiar with oncology labeling for approved cancer therapies. Each one-hour episode explores a different oncology product’s journey from development to approval, featuring discussion from FDA reviewers, clinical trial investigators, patients, pharmaceutical company officials, and in this most recent episode, an oncology pharmacist.
*Continuing Medical Education Activity AMA PRA Category 1 CreditsTM are available.*
In this episode:
- Jennifer Gao, MD – Associate Director for Education, Oncology Center of Excellence, FDA
- Mirat Shah, MD – Physician, Division of Oncology 1, FDA
- Vassiliki Karantza, MD – Associate Vice President, Global Clinical Development, Merck
- Heather McArthur, MD – Clinical Director of Breast Cancer, University of Texas Southwestern Medical Center
- Demetria Lam – Patient
- Sandra Cuellar Puri, PharmD – Clinical Associate Professor, Department of Pharmacy Practice, University of Illinois at Chicago College of Pharmacy
Project Livin’ Label is completely free, but you do need to register to watch the episodes.
NCI Seminar Series Highlights Research in Understudied Populations and Cancer Disparities
-Calais Prince, PhD
There has been considerable progress made against cancer, however, these advancements have not been experienced by everyone. Cancer disparities are persistent across race and ethnicity as well as in populations that are marginalized by geographic location or sexual orientation. The cancer burden within these diverse groups is currently understudied. This has led to limited epidemiologic data on relevant health risks and outcomes to inform evidence-based cancer control, prevention, and intervention efforts.
NCI’s Epidemiology and Genomics Research Program hosts a quarterly webinar series that highlights research on understudied populations and disparities associated with outcomes across the cancer control spectrum. The panel of speakers at the upcoming September 14 webinar, “Addressing Systemic Racism in Cancer Prevention and Control: Sharing Opportunities and Experiences,” will present findings from the U.S. Preventive Services Task Force methods report and offer two examples of current work, practice, and research to mitigate the impact of racism on clinical preventive services and health systems. For those interested in attending the virtual event, registration is required.