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Cancer Policy Monitor: December 9, 2025

Congress Faces an Uncertain Path on FY2026 Spending Bills Ahead of the January 30 Deadline 

–Carly McCallie

Although lawmakers ended the 43-day shutdown in November by passing a short-term continuing resolution (CR) and three full-year spending bills, nine bills remain unresolved and all major health agencies, including the National Institutes of Health (NIH) and Health and Human Services (HHS), are operating under funding that expires on January 30. 

The full-year bills already enacted cover the Legislative Branch; Military Construction and Veterans Affairs; and Agriculture, Rural Development, and the Food and Drug Administration. These measures are law through the end of fiscal year (FY) 2026. Everything else is tied to the CR. 

Senate Majority Leader John Thune (R-SD) acknowledged last week that the Senate may not be able to advance another package before the holiday recess despite repeated attempts to assemble a bipartisan bundle for debate. Even if the Senate clears a package this month, it would still need agreement with the House to avoid another funding lapse. 

Senator Shelley Moore Capito (R-WV) said Senate Republicans continue to work on a multibill package that includes Defense; Labor, Health and Human Services, and Education; Interior; Transportation; Commerce; and Justice. When combined with the three bills enacted in November, that package would fund about 90 percent of federal operations. Capito noted that negotiations may extend into January but stressed the importance of keeping the government open after the disruption caused by the previous shutdown. 

House appropriators are confronting their own set of obstacles. Chair Tom Cole (R-OK) and several subcommittee leaders met last week with White House Chief of Staff Susie Wiles to review the status of the nine remaining bills. Significant disagreements over spending levels and policy language persist, and House leaders have not yet reached a bipartisan understanding with their Senate counterparts. GOP conservatives in the Senate also voiced objections to proposed spending levels in their meeting with Thune, underscoring divisions that continue to complicate progress. 

With Congress set to adjourn in mid-December and no topline agreement for FY2026 in place, the timeline is tightening. For NIH and the National Cancer Institutes (NCI), the unresolved appropriations picture means ongoing uncertainty for grants, planning, and staffing. Lawmakers say they hope to avoid another shutdown, but the January 30 deadline is approaching quickly, and the work needed to meet it remains unfinished. 

AACR Releases Inaugural Edition of the Pediatric Cancer Progress Report 

-David Zahavi, PhD

On December 4, 2025, the American Association for Cancer Research (AACR) released the inaugural edition of its Pediatric Cancer Progress Report, a landmark publication that provides a detailed overview of the tremendous progress made over the last decade in the prevention, detection, and treatment of pediatric cancer, and how these advances crucially depend on robust and sustained federal investments in research and support programs. 

The report highlights ongoing and emerging trends in the field, the needs of pediatric cancer survivors, and the global landscape of pediatric cancer. The report also featured inspiring stories from patient advocates, as well as Congressional features from Senator Michael Bennet (D-CO), Representative Michael McCaul (R-TX), and Representative Ami Bera (D-CA), who shared their dedication to advancing pediatric cancer research and driving progress towards a cure. 

A congressional briefing to release the AACR Pediatric Cancer Progress Report 2025 was held in the Kennedy Caucus Room of the Russell Senate Office Building in Washington, D.C., and drew hundreds of attendees in person and online to hear about the amazing advances that have been made in the fight against pediatric cancer and personal stories that relay the impacts of pediatric cancer research. At the briefing, AACR Chief Executive Officer Margaret Foti, PhD, MD (hc), presented the report alongside Congressman Michael McCaul (R-TX); the chairs of the AACR Pediatric Cancer Progress Report 2025 steering committee, Elaine Mardis, PhD, and Kimberly Stegmaier, MD; National Cancer Institute Director Anthony Letai, MD, PhD; as well as survivors featured in the report and their families, who underscored why continued federal support for pediatric cancer research is essential for progress. 

A recording of this important briefing is available on Youtube, and the AACR Pediatric Cancer Progress Report 2025 can be read online. 

New Reports Detail Impact of NIH Funding Cuts on Clinical Trials and cancer research 

-David Zahavi, PhD 

Cancer clinical trials are a critical component of the multifaceted research effort to develop and test new treatments, and lead to the discovery of new drugs, therapies, and prevention methods. Federally funded clinical trials play a crucial role in advancing cancer research, patient care, and improving patient outcomes. Funding cuts or disruptions to the National Institutes of Health (NIH) and National Cancer Institute (NCI) will acutely affect the ability of researchers to conduct clinical trials as well as publish and disseminate clinical trial results. However, the exact impact of recent funding cuts and grant terminations on clinical trials had yet to be quantified. A recent analysis published in JAMA Internal Medicine details how actions by the Trump administration have resulted in hundreds of NIH-funded clinical trials losing grant support. The study found that, between February 28 and August 15, 383 out of 11,008 active NIH-funded clinical trials (approximately 3.5%) had their funding abruptly cut, totaling $1.8 billion in lost support. These disruptions affected over 74,000 patients enrolled in active trials, including those in over 115 cancer studies. Another recent study published in JAMA Oncology reported that 181 individual NCI funded grants were terminated, amounting to over $640 million. Over half of the investigators whose grants were terminated were mid-level or early career researchers, and 61% of the terminated grants were for basic science research. Without reliable federal funding, cancer research progress will slow, clinical trials will continue to stall, and promising treatments will remain out of reach for many. 

Such disruptions to cancer research not only delay scientific discovery, they also threaten patient trust, the cancer research workforce, and infrastructure needed to support future trials and research overall. Abrupt terminations compromise not only patient follow up and safety monitoring but also the generation of high-quality evidence needed to advance therapies. Continued disruptions may discourage patient participation in clinical trials and undermine the credibility of the research enterprise. These new reports underscore how consistent and predictable NIH funding that supports clinical trials and basic research is critical for making progress against cancer. 

Turnover Continues at FDA Center for Drug Evaluation and Research      

–Brad Davidson, PhD

On November 11, Richard Pazdur, MD, was selected to lead the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). This important center is charged with regulating most prescription drugs and over-the-counter medicines. Pazdur is a 26-year veteran of CDER, where he has led the regulation of oncology products as director of the Office of Oncologic Diseases and director of the cross-center FDA Oncology Center of Excellence.  

Both in the official FDA announcement and a subsequent episode of the FDA Direct Podcast, FDA Commissioner Marty Makary, MD, touted Pazdur as a regulatory innovator. Particularly, Makary and FDA Center for Biologics Evaluation and Research (CBER) Director Vinay Prasad, MD, MPH, who also spoke on the podcast, highlighted the potential to develop additional cross-center structures similar to Pazdur’s OCE to streamline and harmonize review across drug classes by disease or organ, including cardiology and nephrology. They additionally endorsed principles frequently used in oncology drug development under Pazdur, whereby development programs seek accelerated approval based on early endpoints to speed patient access and full approval or withdrawal is based on subsequent readouts of validated surrogate endpoints of clinical benefit or confirmed clinical benefit. Oncology experts across academia, industry, and advocacy, including the AACR, largely heralded Pazdur’s selection as a boon for both drug development and patients, given his reputation for innovation, rigor, and candor.  

By early December, only a few weeks after being named to lead CDER, it was announced that Pazdur is set to retire from the agency by January 2026. He will be replaced as CDER director by Tracy Beth Høeg, MD, PhD, a sports medicine physician who joined the FDA in early 2025 as a key advisor to the Commissioner. As of writing, a successor has not been named for director of the Oncology Center of Excellence. Høeg is the fifth leader of CDER in a little over a year, a time period that has been marked by extensive turnover at the FDA. In her time at the agency, Høeg has been known for investigating potential deaths related to vaccination and her involvement in vaccine policy. Twelve former FDA commissioners recently denounced expected and ongoing changes to vaccine regulation and policy at the agency in an article in the New England Journal of Medicine.   

AACR Publishes Policy Statement in Favor of FDA Rule to Reduce Nicotine Levels in Combusted Tobacco Products 

-Brad Davidson, PhD

The American Association for Cancer Research (AACR) recently released a policy statement in support of a rule proposed by the U.S. Food and Drug Administration (FDA) that would limit the amount of nicotine in certain combusted tobacco products to non-addictive or minimally addictive levels. If finalized, the rule would reduce nicotine levels in cigarettes and other selected products by approximately 95%. The policy statement, written by members of the AACR Tobacco Products and Cancer Subcommittee, was published in the AACR journal Clinical Cancer Research.  

The AACR has long supported the development of this proposed rule. In 2018, the AACR submitted a public comment to the FDA’s Advanced Notice of Proposed Rulemaking supporting a tobacco product standard that would limit the maximum nicotine level in cigarettes to minimally or non-addictive levels because of the transformative impact such a policy would have on the national cancer burden and overall public health. A recent FDA analysis determined that 12.9 million additional people who smoke would quit smoking within the first year, 19.5 million would quit within five years, and 1.8 million deaths would be avoided by 2060 if this rule were enacted.  

The article synthesizes the abundance of evidence supporting this policy. Numerous clinical trials have demonstrated that combusted tobacco products with very low nicotine content encourage smoking cessation across every demographic group. However, not all groups might benefit equally from such a rule. As such, the statement proposes additional supporting policies that would magnify the impacts of the FDA rule, including increased access to nicotine replacement therapies to help facilitate quitting, continued support for federal tobacco control programs, track and trace programs to prevent the growth of illegal cigarette markets, and sustained and broad communication efforts to inform the public of policy changes.  

To learn more, visit the Cancer Research Catalyst interview with lead authors of the statement.   

Applications Now Open for the 2026 AACR Scientist↔Survivor Program and Advocate Partners Pavilion

The Scientist↔Survivor Program (SSP) is a pioneering initiative that connects cancer patient advocates with leading cancer researchers to foster collaboration, education, and dialogue. Through this immersive experience, advocates gain a deeper understanding of cancer science and contribute their perspectives to the research community. 

Selected participants will engage in customized educational sessions, attend scientific presentations, and collaborate with scientists and fellow advocates throughout the meeting. For more information and to apply, please visit the application page below. 

In addition, applications are also open for the Advocate Partners Pavilion, an exhibit space that showcases the work and resources of advocacy organizations during the Annual Meeting. 

Scientist↔Survivor Program Application 

Advocate Partners Pavilion Application 

Questions may be directed to [email protected]. 

Applications Now Open for 2026 Early-Career Hill Day 

The American Association for Cancer Research (AACR) is now accepting applications for its 2026 Early-Career Hill Day, which will be held in Washington, D.C., March 17-18. This annual event provides a valuable opportunity for AACR Associate members to learn about the advocacy process by taking their message directly to members of Congress in support of federal funding for cancer research at the National Institutes of Health and the National Cancer Institute. 

Participants will receive training on advocacy and the federal appropriations process prior to the Hill Day. Please visit this page for more information and to apply for one of the limited spots to attend and network with fellow early-career Associate members. The deadline to apply is Monday, December 15. 

Potential applicants who are not already AACR Associate members can find more information about membership. There are no annual dues for Associate members. Any questions may be directed to [email protected]. 

Patient-Centered Outcomes Research Institute Opportunities 

-David Zahavi, PhD 

The Patient-centered Outcomes Research Institute (PCORI) issued a PCORI Funding Announcement (PFA) on December 2, soliciting high-impact, patient-centered comparative clinical effectiveness research (CER) projects led by researcher and community partnerships to focus on advancing care and outcomes across different phases of the cancer care continuum. PCORI is particularly interested in submissions that address the following Special Areas of Emphasis: 1) Addressing barriers to recommended cancer screening and timely follow-up in the general population and among individuals at high risk of cancer; 2) Improving the delivery of patient-centered, evidence-based care during cancer treatment, and/or 3) Addressing the post-treatment, follow-up care needs of cancer survivors. Proposed projects should help inform health decisions for patients, caregivers, and communities in the United States experiencing high burdens and practice variations in cancer care and outcomes. Letters of Intent to submit an application will be due by January 6, 2026, at 5 p.m. ET. An applicant town hall is being held December 9 at 12 p.m. ET. More information is available online. 

In addition, PCORI has opened the application period for Advisory Panel membership. PCORI’s advisory panels are an incredible opportunity for researchers and communities to get involved with PCORI and help ensure a diverse set of voices and lived experiences are heard. PCORI is seeking experienced voices from all backgrounds for four multidisciplinary advisory panels: 

  • Comparative Clinical Effectiveness Research Advisory Panel 
  • Clinical Trials Advisory Panel 
  • Rare Disease Advisory Panel 
  • Patient Engagement Advisory Panel 

Serving on a PCORI advisory panel will help guide the future of PCORI’s patient-centered comparative clinical effectiveness research. Panelists help guide research funding priorities, empower individuals to make informed healthcare decisions, and join a community of individuals committed to advancing patient-centered outcomes. 

The application cycle will close March 6, 2026. Learn more online.   

Oncology Approval Recap  

-Brad Davidson, PhD

Between October 24 and November 24, the U.S. Food and Drug Administration (FDA) issued numerous  approvals for oncology drug products:  

  • Revumenib was approved for relapsed or refractory acute myeloid leukemia with a susceptible NPM1 mutation in patients 1 year and older who have no satisfactory alternative treatment options. This was the second indication approved for this therapeutic. Review made use of the Real-time Oncology Review program, and the application received priority review and the fast track designation.   
  • Daratumumab and hyaluronidase-fihj was approved as a monotherapy for adults with high-risk smoldering multiple myeloma. This therapeutic was previously approved for multiple indications in multiple myeloma, but this is the first ever approval of a therapeutic in the precursor smoldering multiple myeloma setting. Previous standard of care involved waiting for progression to symptomatic multiple myeloma prior to initiating treatment. The benefit-risk profile of this treatment was the subject of a recent meeting of the Oncologic Drugs Advisory Committee, where concerns included the choice of endpoint and its potential immaturity, the definition of “high-risk” used, and the representativeness of patients in the supporting trial. Ultimately, the committee voted 6-2 in favor of this indication.  Additionally, this treatment was also converted from an accelerated approval, received in 2021, to a traditional approval in combination with bortezomib, cyclophosphamide, and dexamethasone for newly diagnosed light chain amyloidosis.  
  • Ziftomenib was approved for adults with relapsed or refractory acute myeloid leukemia with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. This is the first ever approval for this drug, which was granted priority review, breakthrough designation, and orphan drug designation.   
  • Pertuzumab-dpzb was approved as an interchangeable biosimilar to Perjeta, a treatment for HER2-positive breast cancer. This is the first approval of a biosimilar for this product.   
  • Epcoritamab-bysp was approved in combination with lenalidomide and rituximab for relapsed or refractory follicular lymphoma. This application was granted breakthrough designation, priority review, and orphan drug designation.  This treatment also received traditional approval for use as a monotherapy for relapsed or refractory follicular lymphoma after two or more lines of systemic therapy, a conversion from accelerated approval in this indication.  
  • Selumetinib was approved for adults with neurofibromatosis type 1 (NF1) who have symptomatic inoperable plexiform neurofibromas. This represents an expansion of a previous approval in this setting that had only included pediatric patients.   
  • Tarlatamab-dlle was granted traditional approval for adults with extensive stage small cell lung cancer with disease progression on or after platinum-based chemotherapy. This is a conversion from accelerated approval, which was initially granted in 2024.  
  • Sevabertinib was granted accelerated approval for adults with locally advanced or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations who have received prior systemic therapy. This is the first approval for this drug product.  Review was conducted under Project Orbis in collaboration with Health Canada, Israel’s Ministry of Health, and the United Kingdom Medicines and Healthcare products Regulatory Agency. This application was granted priority review, breakthrough designation, and orphan drug designation.    
  • Pembrolizumab or pembrolizumab berahyaluronidase alfa-pmph in combination with enfortumab vedotin-ejfv was approved for use as a neoadjuvant followed by adjuvant treatment after cystectomy for adults with muscle invasive bladder cancer who are ineligible for cisplatin. Review of this application was conducted under Project Orbis, and included the Australian Therapeutic Goods Administration, Health Canada, Swissmedic, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency. This application was granted priority review, and was approved five months ahead of its FDA goal date.