Cancer Policy Monitor: May 9, 2023
- May Is National Cancer Research Month
- AACR to Hold Joint Hill Day with AACI
- One-Year Anniversary of Proposed Menthol and Flavor Prohibition is Reminder to Promote Health Equity
- AACR 2023 Regulatory Science and Policy Sessions Now Streaming On-Demand
- Save the Date: AACR-ASA-FDA Workshop on Overall Survival in Oncology Clinical Trials
- AACR Staff Participate in Alliance for Childhood Cancer Action Days
- Save the Date! The 11th Annual Rally for Medical Research
May Is National Cancer Research Month
The American Association for Cancer Research (AACR) initiated and supports National Cancer Research Month to highlight the importance of lifesaving research to the millions of people around the world affected by the collection of devastating diseases we call cancer. Learn more.
AACR to Hold Joint Hill Day with AACI
The AACI and the Association of American Cancer Institutes (AACI) will hold a joint Hill Day on May 18 to advocate for continued investment in the National Institutes of Health (NIH) and the National Cancer Institute (NCI). This event will provide a valuable opportunity for cancer researchers, physicians, survivors, patient advocates, and cancer center leaders to engage in advocacy at the federal level on the importance of continued success for cancer research and the delivery of care. The first in-person Hill Day since 2019, this year’s event will include at least 75 participants from more than 25 states. Participants will attend over 100 meetings with congressional offices to share their stories with members and staff and emphasize the importance of increased funding for NIH and NCI. This year, participants will ask Congress to continue to prioritize medical research by providing at least $50.924 billion for NIH, a $3.465 billion increase over the FY 2023 program level; and to support $9.988 billion for the NCI, an increase of $2.6 billion as recommended in the NCI Director’s Professional Judgment Budget.
Before meeting with legislators, Hill Day participants will gather for a reception on May 17 to honor Congresswoman Debbie Wasserman Schultz (D-FL) and Congressman Brian Fitzpatrick (R-PA) for their efforts in fighting cancer. Of note, key participants in the Hill Day will include current AACR President Philip D. Greenberg, MD, FAACR, and AACR Science Policy and Government Affairs Committee Chairperson Roy S. Herbst, MD, PhD.
The AACR is pleased to work with the AACI on hosting this important event to highlight the importance of supporting biomedical innovation and cancer centers.
One-Year Anniversary of Proposed Menthol and Flavor Prohibition is Reminder to Promote Health Equity
-Calais Prince, PhD
More than 18.5 million people aged 12 years and older in the United States smoke menthol cigarettes. Considerable research indicates menthol and other flavors in cigarettes increase smoking initiation, cigarette use, and nicotine dependence. To further decrease cigarette consumption, the Center of Tobacco Products (CTP) at the U.S. Food and Drug Administration (FDA) published two proposed product standards in April 2022 to prohibit the manufacturing, distribution, and sale of menthol cigarettes and flavored cigars. Finalizing the product standard and banning menthol cigarettes and flavored cigars would reduce the appeal of these products, and ultimately, tobacco-related disease and death.
During the AACR Annual Meeting 2023 session “FDA Center for Tobacco Products’ Priorities to Address Tobacco Use and Support the Cancer Moonshot,” FDA CTP Director Brian King, PhD, MPH, highlighted the progress made toward promoting health equity through tobacco regulation. In the year since publishing the proposed standards to ban menthol in cigarettes and all flavors in cigars, CTP received and reviewed 250,000 public comments that require a response. Conference attendees also learned that a final ruling is expected to be made by the end of this year. Dr. King also discussed many more CTP programs and initiatives to address health equity, such as the plan to develop a proposed product standard to establish maximum nicotine levels in tobacco products, progress made in enforcing the Federal Food, Drug, and Cosmetic Act, and expanding culturally appropriate public education campaigns.
Data-driven, forward-thinking, population-based strategies are needed to end tobacco-related diseases and mortality. The AACR will continue to advocate for a ban on menthol and other characterizing flavors in tobacco products.
AACR 2023 Regulatory Science and Policy Sessions Now Streaming On-Demand
-Nicholas Warren, PhD
The American Association for Cancer Research (AACR) Annual Meeting provides an opportunity for the world’s leading cancer researchers to present state-of-the-art basic, translational, clinical, population, and prevention research to an international audience. This April, the 2023 Annual Meeting drew more than 20,000 in-person attendees to the Orange County Convention Center in Orlando, Florida, to share the latest breakthroughs in the struggle to cure all cancers. The Annual Meeting also provides a forum for the cancer research community to engage with the U.S. Food and Drug Administration (FDA) through the Regulatory Science and Policy (RegSci) Track. This year’s RegSci Track included nine timely sessions on important current challenges for clinical drug development with a focus on panel discussions and interactive audience participation. In case you missed a session, the Regulatory Science and Policy Track as well as other exciting Annual Meeting sessions will be available for on-demand streaming to registered attendees on the Annual Meeting website through July 19.
Some of the most well-attended RegSci Track sessions discussed liquid biopsies, implementing diversity action plans, and decentralizing clinical trials. There is a lot of excitement about the potential to use circulating tumor DNA (ctDNA) from liquid biopsies as an early efficacy endpoint in clinical trials or prognostic indicator to identify patients at high risk of recurrence. However, FDA officials participating in the session said additional prospective randomized studies are needed to validate ctDNA as an endpoint with similar quality to other early endpoints like progression-free survival. In April 2022, the FDA released guidance for drug developers to create diversity action plans to help enroll trial participants who reflect the diversity of real-world patients intended to receive new drugs. The RegSci session on diversity action plans included practical advice from several pharmaceutical companies on how they are implementing diversity strategies into their drug development pipeline. Additionally, decentralizing trials brings promise to improve trial diversity as well as decrease the burden of participating in trials for all patients. Panelists in the decentralized trials session stressed the point that every trial has at least some decentralized component, the question is how much further can trials go to make it as easy as possible for patients to participate. The overall message from these sessions was that trial sponsors who bring innovative trial designs, diversity strategies, and decentralized elements will have a competitive advantage to increase the speed and size of patient enrollments and with patients that better reflect real-world use. Ultimately, these improvements to clinical research have the potential to identify better therapies to improve the lives of patients with cancer.
Save the Date: AACR-ASA-FDA Workshop on Overall Survival in Oncology Clinical Trials
-Nicholas Warren, PhD
The American Association for Cancer Research (AACR), American Statistical Association (ASA), and U.S. Food and Drug Administration (FDA) are partnering to host a workshop July 18, 2023, at the Bethesda Marriott Pooks Hill hotel in North Bethesda, Maryland, to discuss the use of overall survival (OS) and other endpoints in oncology clinical trials.
OS is considered a gold standard endpoint for clinical trials because it measures both efficacy and safety of new therapies. It is also a relatively simple and straightforward metric that matters to patients who want to know if a drug will help them live longer. Advancements in cancer care have improved the lives of many patients, however, it is becoming increasingly difficult to measure OS in a timely fashion to support approval of new drugs. This is leading to the growing use of early endpoints like progression-free survival or durable response rates for submissions to the FDA. When early endpoints are used, FDA will often require companies to share OS data when they become available following Accelerated Approval or Traditional Approval. Unfortunately, several factors can pose challenges for monitoring long-term OS, including differences between subpopulations; crossover trial designs; subsequent lines of therapy after a patient leaves a trial; and fluctuations in the magnitude of benefit compared to the control arm over time.
These issues and more will be discussed in the upcoming workshop this July. Please stay tuned for details on how to register to attend in person or virtually.
AACR Staff Participate in Alliance for Childhood Cancer Action Days
Members of the AACR Office of Science Policy and Government Affairs took part in the Alliance for Childhood Cancer Action Days on April 24-25, 2023, in Washington, D.C. The two-day event marked the first in-person Action Days since 2019.
The AACR is a full member of the Alliance for Childhood Cancer, which was established in 2021 to advocate for pediatric cancer patients and their loved ones. This year, the Action Days brought together more than 200 participants from 34 states to attend over 150 meetings with congressional offices. Throughout the day, young patients, their family members, and advocacy professionals shared personal stories about their cancer journey. To make much-needed progress in the fight against childhood cancer, the participants asked Congress to continue to prioritize medical research by providing at least $50.924 billion for the National Institute of Health’s (NIH) foundational work, a $3.465 billion increase over the FY 2023 program level; and support $9.988 billion for the National Cancer Institute (NCI), an increase of $2.6 billion as recommended in the NCI Director’s Professional Judgment Budget. The participants also urged Congress to fully fund both the Childhood Cancer STAR Act and the Childhood Cancer Data Initiative, and they asked members of the House of Representatives to join the Childhood Cancer Caucus.
The day before participants attended congressional meetings, Sen. Jack Reed (D-RI) delivered remarks on the important role advocates play in ensuring that Congress continues to prioritize investment in biomedical research. Participants also attended sessions hosted by advocacy professionals on how to share their story and structure their congressional meetings. The AACR is proud to work with the Alliance for Childhood Cancer to advocate for additional investments in the NIH and NCI and crucial support for childhood cancer patients and their families.
Save the Date! The 11th ANNUAL Rally for Medical Research
The 11th Annual Rally for Medical Research Hill Day will take place Thursday, September 14, in Washington, D.C., bringing patients, caregivers, researchers, clinicians, and other advocates together for meetings with congressional offices in support of funding for the National Institutes of Health (NIH). A reception for attendees will be held Wednesday, September 13. For more information, please visit the Rally’s website or contact [email protected].