In This Section

Cancer Policy Monitor: March 11, 2025

President Donald Trump’s Second Administration Begins with Bold Policy Moves

-Carly McCallie

Early actions by the Trump Administration, including freezing federal funding, canceling grant review panels, and the nomination of vaccine skeptic RFK Jr. as Health and Human Services (HHS) Secretary, have sparked concerns about disruptions to biomedical research and public health.

Trump Administration Creates “Make America Healthy Again” Commission

-Blake William Rostine

On February 13, the Senate approved Robert F. Kennedy Jr.’s nomination to serve as Secretary of HSS in a 52-48 vote. The White House shortly thereafter issued an Executive Order establishing the Make America Healthy Again (MAHA) Commission, a new initiative focused on addressing chronic disease and improving national health outcomes.

In its press release, the administration highlighted alarming public health trends, including stating, “The United States has the highest age-standardized cancer incidence rate across 204 countries, nearly double the next-highest rate. From 1990 to 2021, the United States saw an 88% increase in cancer.”

Both President Trump and Secretary Kennedy have emphasized that tackling the nation’s chronic illness epidemic will be a central priority for the administration. As part of its mission, the Commission has identified four key policy priorities to guide its work:

  • Transparency and Open-source Data: Ensure all federally funded health research is transparent, utilizes open-source data, and avoids conflicts of interest.
  • Prioritizing Root-cause Research: Focus federal health-related research on understanding why Americans are getting sick, emphasizing gold-standard studies into the root causes of illnesses.
  • Enhancing Food Quality: Collaborate with farmers to ensure that U.S. food is the healthiest, most abundant, and most affordable globally.
  • Expanding Treatment and Prevention Options: Ensure the availability of diverse treatment options and promote health coverage flexibility to support beneficial lifestyle changes and disease prevention.

As the new administration sets its health policy priorities, the AACR is committed to ensuring that cancer research remains a national priority in efforts to improve public health. We look forward to working with policymakers to advance evidence-based strategies that accelerate progress toward lifesaving discoveries and ultimately ending cancer as we know it.

Legislative Update

–Carly McCallie

With the March 14, expiration of the current continuing resolution (CR) quickly approaching, congressional leaders face mounting pressure to finalize Fiscal Year (FY) 2025 appropriations. However, deep divisions over spending priorities and the implementation of federal funding have stalled progress, increasing the risk of a government shutdown.

House Speaker Mike Johnson (R-Louisiana) and Republican appropriators have outlined a “two-track strategy” that includes both a stopgap funding measure and continued negotiations on a full-year spending deal. House Appropriations Chair Tom Cole (R-Oklahoma) has reiterated that bipartisan talks are ongoing, though House Republicans are expected to release the text of a full year stopgap funding bill by the weekend. This move has drawn strong opposition from Democrats, who are pushing for guarantees that President Trump will fully implement appropriated funding and are concerned about the long-term impact of a short-term CR.

President Trump has publicly supported a long-term CR lasting until the end of September, adding another layer of uncertainty to the negotiations. Meanwhile, Democrats, including House Appropriations Ranking Member Rosa DeLauro (D-Connecticut) and Senate Appropriations Vice Chair Patty Murray (D-Washington), have criticized Republican leadership for stepping away from bipartisan negotiations, warning that continued delays in finalizing appropriations will only heighten instability for federal agencies and vital programs.

The prolonged uncertainty surrounding FY 2025 appropriations poses an immediate threat to the future of cancer research, as continued delays in funding decisions stall National Institutes of Health (NIH) and National Cancer Institute (NCI) grant awards, disrupt groundbreaking research initiatives, weaken the pipeline of early-career scientists, and undermine the stability of cancer research institutions. These disruptions jeopardize both the pace of scientific discovery and the ability to deliver new, lifesaving treatments to patients.

As lawmakers negotiate federal funding, the AACR continues to advocate for cancer researchers, patients, and advocates, urging Congress to provide robust and predictable investments in biomedical research. Through direct engagement with policymakers and mobilization of the research community, the AACR is working to secure the resources necessary to drive scientific progress and improve patient outcomes.

Accelerating Kids’ Access to Care Act Reintroduced in the 119th Congress

-Blake William Rostine

The Accelerating Kids’ Access to Care Act (AKACA) (H.R. 1509; S. 752), a bipartisan bill championed by the childhood cancer community, has been reintroduced in the 119th Congress. The legislation seeks to amend Medicaid and the Children’s Health Insurance Program (CHIP) to make it easier for families to access specialized, lifesaving treatments across state lines. This would remove barriers for children needing specialized care unavailable in their home states.

The bill was introduced in the House on February 21 by Representative Lori Trahan (D-Massachusetts) and referred to the House Committee on Energy and Commerce. In the Senate, Senators Michael Bennet (D-Colorado) and Chuck Grassley (R-Iowa) introduced the bill on February 27.

In the 118th Congress, the bill garnered strong bipartisan support, with 124 cosponsors, and came close to becoming law. However, it was ultimately left out of the continuing resolution passed in December 2024 to avert a government shutdown.

The bill’s reintroduction has once again secured broad bipartisan backing, with 29 original cosponsors in the Senate and 14 cosponsors in the House. The AACR will continue working with legislators and the broader advocacy community to advance this critical legislation, ensuring that children and their families can more easily access the lifesaving care they need.

AACR Holds 10th Annual Early-Career Hill Day

On February 26, the AACR hosted its 10th annual Early-Career Hill Day (ECHD), bringing together AACR Associate members to advocate for robust, sustained funding for the National Institutes of Health (NIH) and the National Cancer Institute (NCI) and to express concerns over recent administrative actions that disproportionately impact early-career scientists and threaten the future of cancer research.

Early-career researchers play a critical role in driving scientific discoveries, conducting the groundbreaking work that leads to new cancer treatments. Yet, funding uncertainties, hiring freezes, and administrative disruptions are placing unprecedented strain on these scientists at a critical stage in their careers. Shrinking federal investments and policy shifts are limiting job opportunities, restricting access to research grants, and forcing promising scientists to leave academia or even the country.

ECHD provided a crucial platform for early-career scientists to bring these concerns directly to Congress. This year, 18 participants from 14 states held over 50 meetings with congressional offices, where they shared their personal experiences and emphasized how federal funding supports their research and fuels the next generation of cancer breakthroughs. Participants urged Congress to prioritize medical research by providing the highest possible funding increase for the NIH in Fiscal Year 2025 to protect America’s leadership in biomedical innovation. They also underscored the need to safeguard NIH from harmful administrative actions that could jeopardize scientific progress and the careers of young investigators.

In conjunction with Hill Day, ECHD participants and the AACR led a National Day of Action, mobilizing early-career scientists and the broader cancer research community to contact their members of Congress via email and social media in support of increased NIH and NCI funding. The campaign sparked significant engagement, with dozens of messages and images shared across Twitter, Facebook, LinkedIn, and other platforms, using the hashtags #AACRontheHill and #FundNIH.

Congress must act now to ensure stable NIH funding, or we risk losing a generation of scientists and the breakthroughs they could deliver. Without decisive action, the United States will fall behind in biomedical innovation, delaying critical medical advances and diminishing our ability to fight cancer.

Join us at the AACR Annual Meeting 2025: Elevating Patient Advocacy in Cancer Research

Patient advocates play a vital role in advancing cancer research. The AACR Annual Meeting 2025 features several educational programs, interactive sessions, and networking opportunities for advocates to engage with leading scientists, clinicians, and policymakers and amplify the patient voice in research. Join us as we unite the cancer community to accelerate innovation and improve patient outcomes.

Learn more online.

FDA Issues Safety Announcement Highlighting DPD Deficiency Testing

-Brad Davidson, PhD

In late January, the FDA Oncology Center of Excellence issued a first-of-its-kind safety announcement to increase awareness of recent safety labeling updates that highlighted the risks of treating patients with dihydropyrimidine dehydrogenase (DPD) deficiency with the fluoropyrimidine chemotherapies capecitabine (Xeloda) and fluorouracil (5-FU). Patients with DPD deficiency have a greatly increased risk of severe and fatal toxicities upon receipt of fluoropyrimidine treatment, which led the European Medicines Agency to recommend testing for DPD deficiency prior to treatment with fluoropyrimidines in 2020 and spurred a Citizen’s Petition calling on FDA to do the same.

These labelling updates were initially performed in 2022 for capecitabine and 2024 for 5-FU as part of the Project Renewal initiative, which seeks to modernize prescribing information for older oncology drugs. Now, the labels encourage healthcare providers to consider testing for the rare genetic condition dihydropyrimidine dehydrogenase (DPD) deficiency prior to initiating fluoropyrimidine treatment and indicate that no dose of fluoropyrimidine is safe for patients with complete DPD deficiency. The label also expresses that providers should inform patients about DPD deficiency and discuss whether they should be tested prior to treatment. The safety announcement puts this in clearer, more direct terms: “All healthcare providers should be aware of the risks of DPD deficiency, inform patients prior to treatment about the potential for serious and life-threatening toxicities due to DPD deficiency, and discuss testing options for DPD deficiency with their patients.” 

Days before the release of this safety announcement, the AACR collaborated with the FDA to hold a public workshop discussing the current state of DPD deficiency testing—including how testing is currently used in the clinic and whether the FDA should recommend testing prior to fluoropyrimidine treatment. It became clear throughout the workshop that testing saves lives, but there are large differences in physician awareness of DPD deficiency, use of patient counseling, and use of testing between and among medical institutions. However, DPD testing is being increasingly implemented in hospital systems throughout the United States, reflecting both cases of severe adverse reactions at their hospitals and growing evidence and patient advocate sentiment in favor of testing. The FDA has committed to continuing to monitor the evolving landscape of DPD deficiency testing in the US.  

Registration Open for the 2025 AACR-AACI Joint Hill Day

The American Association for Cancer Research (AACR) and the Association of American Cancer Institutes (AACI) invite you to Capitol Hill on Thursday, May 22. This Hill Day will bring cancer center directors, researchers, physician-scientists, cancer survivors, and other advocates to Capitol Hill to build support for a strong federal investment in biomedical research, and cancer research in particular, through the National Institutes of Health (NIH) and the National Cancer Institute (NCI).

Learn more and register online for the AACR-AACI Hill Day.

Oncology Approval Recap

-Brad Davidson, PhD

Between January 25 and February 28, the U.S. Food and Drug Administration (FDA) issued two approvals for novel drugs, as well as approval in a new indication for two previously approved therapeutics. 

  • Fam-trastuzumab deruxtecan-nxki was approved for adult patients with unresectable or metastatic hormone receptor-positive, HER2-low or HER2-ultralow breast cancer that progressed during treatment with one or more endocrine therapies in the metastatic setting. This application, which received priority review and breakthrough designation, constitutes the fourth approved indication for this drug in breast cancer and its seventh overall.
  • Mirdametinib was approved for pediatric patients two years of age and older as well as adults with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas not amenable to complete resection. This is the first approval for this drug, whose review was supported by priority review status, fast track designation, and orphan drug designation.
  • Brentuximab vedotin was approved in combination with lenalidomide and a rituximab product for adults with various types of relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy who are also ineligible for autologous hematopoietic stem cell transplantation or CAR T-cell therapy. This drug first received accelerated approval in 2011 for the treatment of certain patients with Hodgkin lymphoma or systemic anaplastic large cell lymphoma—this is its first approval in the LBCL setting and eighth indication overall.
  • Vimseltinib was approved for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection would potentially cause significant morbidities. This is the first approval of vimseltinib in any indication and the first targeted therapy for TGCT. This application was granted priority review status, speeding its review process.