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Cancer Policy Monitor: September 10, 2024

Appropriations Update

-Jon Retzlaff, MBA

The House and Senate returned from their summer recess on September 9, which leaves them little time to resolve the fiscal year (FY) 2025 appropriations bills before the end of the fiscal year on September 30. Therefore, Congress will very likely pass a temporary funding measure (a continuing resolution) to fund the government at its current operating levels until late 2024 or possibly even extend it into early 2025.

As you may remember, prior to the Senate adjourning for its August recess, the Senate Appropriations Committee approved the Senate Labor-HHS-Ed Appropriations Subcommittee bill, which would provide National Institutes of Health (NIH) with a $1.8 billion increase to $48.9 billion in FY 2025. This 4% increase for NIH compares to flat funding in the version of the bill proposed in July by the House Labor-HHS-Education Appropriations Subcommittee.

We are indebted to our leaders in the Senate, most specifically Senate Appropriations Committee Chair Patty Murray (D-WA) and Senate Appropriations Committee Ranking Member/Vice Chair Susan Collins (R-ME), as well as Senators Tammy Baldwin (D-WI) and Shelley Moore Capito (R-WV), who serve as the chair and ranking member, respectively, on the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies, for their efforts to prioritize a robust funding increase for NIH in FY 2025. First, they worked in a bipartisan manner to make available an additional $13.5 billion in emergency funding for nondefense spending accounts in FY 2025, and second, they then allocated a significant amount of that extra funding to NIH to ensure that our nation’s leading researchers will have access to the resources that are necessary to make the scientific discoveries that lead to life-saving cures and improve the health and well-being of people across the nation and around the world.

FDA Releases Finalized Guidance on Dose Optimization for Cancer Treatments

-Rukiya Umoja, PharmD

On August 8, the U.S. Food and Drug Administration (FDA) finalized draft guidance intended to help sponsors identify optimized dosages for newer cancer therapies. This final version, entitled “Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases,” replaces the draft guidance issued by the FDA in January 2023. The draft guidance emphasized that the historical use of the maximum tolerated dose (MTD) in cancer clinical studies may not be the best approach, particularly for targeted therapies, and that rational dose optimization plans should be developed.

This long-awaited finalized guidance comes after several multistakeholder meetings, including a day-and-a-half workshop in February 2024 hosted by the American Association for Cancer Research (AACR) and the FDA to discuss best practices and methods for evaluating all nonclinical and clinical data and how to incorporate modeling and simulation to identify optimized dosages; consider innovative clinical trial designs; and highlight ongoing efforts from stakeholders. 

The FDA acknowledges the need for regulatory flexibility, and highlighted in the final guidance that the agency can provide product-specific advice since there is not a “one size fits all approach.” Implementing these changes may call for a paradigm shift in drug development, but it’s a necessary change that shows great promise in improving long-term outcomes for individuals living with cancer. The AACR looks forward to continued engagement with the FDA, academia, the pharmaceutical industry, patient advocates, and all other stakeholders on the future of dose optimization in cancer clinical studies.   

Biden Administration Announces $150 Million in Research Grants to Improve Tumor Removal

-Matt Gontarchick

President Joe Biden announced on August 13 an investment of up to $150 million in a new program to develop technologies for tumor removal surgeries. The grants will be administered by the Advanced Research Projects Agency for Health (ARPA-H).

The president announced the program at Tulane University, where he reiterated his confidence that the Cancer Moonshot will reach its goal of reducing the cancer mortality rate by 50% by 2024. In addition to Tulane, seven other institutions were awarded grants: Dartmouth College; Johns Hopkins University; Rice University; University of California, San Francisco; University of Illinois Urbana-Champaign; University of Washington; and Cision Vision, a developer of medical imaging devices.

For the millions of Americans diagnosed with tumors each year, surgical removal is usually the first treatment. The new investment aims to make the removal of cancerous tumors more accurate through the development of new technologies. Higher accuracy in tumor removal would reduce the need for repeat surgeries as well as reduce the frequency of unintentional injuries to blood vessels, nerves, and other structures. Inaccurate tumor removal also contributes to harder recoveries, cancer recurrence, and higher health care costs.

Operating under ARPA-H’s Precision Surgery Initiative (PSI), the program requires that all new technologies be compatible for all users. The PSI also requires that grant recipients be committed to health equity, which means that the novel technologies must be designed with lower costs in mind and tested in rural areas.

The program’s rollout comes amid a gradual increase in cancer rates in the U.S.; as estimated two million Americans were diagnosed with cancer in 2023. The AACR applauds the administration for its commitment to supporting the development of novel treatments and technologies for cancer.

AACR to Release 2024 Cancer Progress Report at National Press Club on September 18

-Blake Rostine

The American Association for Cancer Research (AACR) will release its Cancer Progress Report 2024 on September 18 at 11:30 a.m. ET at the National Press Club in Washington, D.C. This year’s report will provide a detailed overview of the tremendous progress that is being made in the prevention, detection, and treatment of cancer, and how these advances crucially depend on robust federal investments in medical research. The report will also highlight how recent advances across the cancer care continuum, including immunotherapy and molecularly targeted therapies, are helping cancer patients and their loved ones.

The event may be attended in person or virtually. Please see the AACR website for additional details. Event registration is available now.

Watch the AACR Patient Advocate Forum: Activating Artificial Intelligence in Cancer Science and Medicine

Thank you for joining us for the AACR Virtual Patient Advocate Forum on August 20. Moderated by Anna Barker, the forum explored how artificial intelligence (AI) is reshaping oncology and shared insights into strategies to navigate the opportunity and uncertainty. If you missed the event or would like to view it again, the recording is available online. If this is your first time viewing the forum, you will need to register.

FDA Oncology Center Invites Pediatric Cancer Advocates to Meet October 15

The FDA Oncology Center of Excellence (OCE) Pediatric Oncology Program is inviting members of the pediatric cancer advocacy community to participate in the 2024 OCE Pediatric Advocacy Forum on October 15. The purpose of this event is to strengthen collaboration and promote more efficient development of new safe and effective drugs and biological products for pediatric patients with cancer.

This forum will feature brief presentations by FDA scientists on topics of interest to the community, followed by informal discussion. Time will also be dedicated to a listening session for advocacy members to provide perspectives on topics of their choice, as well as networking for those who attend in person.

The OCE Pediatric Advocacy Forum will be held from 9 a.m.-1 p.m. ET on October 15. Attendance can be in-person at the FDA White Oak Campus in Silver Spring, Maryland, or virtual.

Visit the Pediatric Advocacy Forum web page for further information and to register to attend.