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Cancer Policy Monitor: August 12, 2025

Congress Pushes Back on NIH Cuts, But Uncertainty Looms 

-Matt Gontarchick 

A White House proposal calling for a 40% reduction in Fiscal Year 2026 (FY2026) National Institutes of Health (NIH) funding has left cancer research advocates and patients deeply concerned. Ever since the administration’s budget request was released in May, stakeholders across the medical research community have warned of the devastating consequences such cuts could bring. Now, leaders in the House and Senate Appropriations Committees are signaling that the reductions may not be as deep as anticipated. 

On Thursday, July 17, the House Appropriations Committee released its FY2026 spending allocations for its 12 subcommittees. The Labor, Health and Human Services, Education, and Related Agencies Subcommittee (Labor-HHS), which determines NIH funding, would receive $184.5 billion. This is slightly below the FY2025 level, reflecting a $37.3 million reduction across the subcommittee’s full jurisdiction. While modest in comparison to the sweeping cuts proposed by the White House, the allocation offers no guarantees and leaves the future of NIH funding uncertain.

The House Labor-HHS Subcommittee had been expected to mark up its bill before the August recess, but that markup was postponed amid broader partisan disagreement over spending levels. Still, Subcommittee Chair Robert Aderholt (R-Alabama) has emphasized the importance of medical research and signaled support for sustaining NIH funding.  

In contrast to the House, the Senate has made more significant progress on NIH appropriations. On July 31, the Senate Appropriations Committee approved by a 25-3 vote a Labor-HHS appropriations bill for FY2026 that would provide NIH with $48.7 billion, a $400 million increase from FY2025. Additionally, the National Cancer Institute would receive $7.374 billion, an increase of $150 million over FY2025. The spending bill advanced by the committee also includes an amendment that would limit the administration’s ability to issue multi-year, forward-funded grants awarded in FY2026 to the same level awarded in FY2024. For any new forward-funded aways beyond the FY2024 level, NIH would be required to ensure that other grants would not be cut. 

During the July 31 hearing to advance the spending bill, committee leaders from both parties expressed a bipartisan commitment for continued investment in NIH. Appropriations Committee Chair Susan Collins (R-Maine) highlighted that the bill includes “targeted funding increases” for cancer research, while Ranking Member Patty Murray (D-Washington) vowed to work with her colleagues to “keep research going.”  

However, FY2026 appropriations for NIH represent only one of the challenges facing the medical research community. The Office of Management and Budget (OMB) has been slow to disperse FY2025 funding to NIH that had already been appropriated by Congress, which has impacted critical, life-saving research across the nation.  

OMB’s pause in funding sparked criticism from lawmakers from both parties. On Thursday, July 24, one of the most significant developments came when Senator Katie Britt (R-Alabama) led 13 of her Republican colleagues in sending a letter to OMB urging the release of delayed FY2025 NIH funding and expressing strong support for continued investment in medical research. The letter described the NIH as “a critical driver of American innovation and discovery” and emphasized its impact on “millions of patients, families, and caregivers.” 

In her press release, Senator Britt reiterated that “funding medical research is not a partisan issue” and called on the administration to lift the holds on NIH grants already appropriated by Congress. As the lead author of the letter, which was signed by 13 Republican colleagues, she emphasized the NIH’s vital role in advancing innovation, saving lives, and offering hope to millions of patients, families, and caregivers. In a separate statement, Britt added that the NIH “helps save lives, improves quality of life, and lowers long-term healthcare costs.”  

Similarly, the office of Senator Murray announced in a July 29 press release that OMB’s funding pause had frozen $15 billion that had been appropriated to NIH for FY2025. Finally, after news reports highlighted the funding pause, OMB reversed course on Wednesday, July 30, and announced that it would allow FY2025 funding for the NIH to resume.  

Despite this momentum, the road ahead remains uncertain. Congress is now in recess until September 2, and with a September 30 deadline looming for FY2026 spending bills, lawmakers face a tight timeline. Most House appropriations bills are expected to align closely with the White House’s proposed cuts. In contrast, the Senate is taking a more bipartisan approach with fewer reductions. A continuing resolution (CR) to avoid an October 1 shutdown appears likely. However, bipartisan agreement may be complicated by the GOP’s passage of a July rescissions package, which was opposed by Democrats and clawed back nearly $10 billion in FY2025 funding. 

Further complicating matters, the White House is expected to propose additional rescissions in the coming weeks. These proposals could deepen partisan divisions and increase uncertainty around NIH funding levels. 

With lawmakers not set to return to Washington until early September and major differences still unresolved, the future of NIH funding remains at risk. The American Association for Cancer Research (AACR) remains committed to protecting investments in cancer research and advocating for robust, predictable NIH funding in FY2026 and beyond. 

CBO Projects Long-Term Decline in Drug Approvals from Health Research Cuts 

-Carly McCallie 

A new analysis from the nonpartisan Congressional Budget Office (CBO) underscores the long-term consequences of proposed federal funding cuts to the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). The report, released on July 18, estimates that a permanent 10% reduction in NIH extramural research funding, combined with staffing-related delays at the FDA, would result in 53 fewer new drugs reaching the market over the next 30 years. 

The CBO’s projections were developed in response to a request from congressional lawmakers who raised concerns about how the administration’s proposed FY26 budget could affect biomedical innovation. The administration’s proposal includes a nearly 40% reduction to the NIH budget and significant staffing reductions at the FDA. According to agency reports, more than 3,500 FDA employees (approximately 15% of the workforce) have been laid off or departed in recent months. 

While the CBO modeled a more conservative 10% cut to NIH funding, it noted that the impact would grow over time, with the largest effects appearing in the third decade. Cuts to other components of the NIH budget, including clinical trial funding, would likely lead to additional declines in new drug development, although those were not included in the scope of this analysis. 

The CBO also examined a scenario in which drug approval timelines at the FDA were delayed by nine months due to reduced staffing. It projected that such delays would result in 23 fewer drugs being approved over the same 30-year period. 

The report emphasizes the connection between public investment in early-stage research and the eventual development of new treatments. Previous studies have shown that nearly all drugs approved by the FDA over the past decade benefited from NIH-supported research. The CBO’s findings suggest that any long-term reduction in that investment would likely be reflected in future therapeutic pipelines. 

The lawmakers who requested the CBO analysis, Senator Jeff Merkley (D-Oregon), Senator Bernie Sanders (I-Vermont), Representative Frank Pallone Jr. (D-New Jersey), and Representative Brendan F. Boyle (D-Pennsylvania), said the findings underscore the far-reaching consequences of disinvestment in federal research. In a joint statement, they emphasized that the proposed cuts would limit access to future treatments, stall progress against diseases like cancer and Alzheimer’s, and weaken a key driver of economic growth. They also pointed to data showing that every one dollar invested in NIH research generates two dollars and fifty cents in economic return.  

While it remains unclear how the final FY26 budget will be shaped, the CBO report is likely to be a key reference point during ongoing appropriations negotiations. It provides one of the clearest quantitative assessments to date of how sustained cuts to federal health research agencies could affect future innovation and patient access to new therapies. 

FDA Names Dr. George Tidmarsh as Director of Drug Evaluation and Research 

The Food and Drug Administration (FDA) has appointed Dr. George Tidmarsh, a Stanford adjunct professor of pediatrics and longtime pharmaceutical executive, to serve as director of the Center for Drug Evaluation and Research (CDER), the agency’s largest and most influential division.

Dr. Tidmarsh succeeds Dr. Jacqueline Corrigan-Curay, who had led CDER in an acting capacity following the departure of former director Dr. Patrizia Cavazzoni earlier this year. In a message to staff, FDA Commissioner Dr. Marty Makary described Tidmarsh as “an accomplished physician-scientist and leader” with experience across the full drug development pipeline, from early research to market approval. 

Tidmarsh brings decades of experience in the biotech industry, having held senior roles at several pharmaceutical companies and contributing to the development of multiple FDA-approved therapies. He served as CEO of Horizon Pharma, where he helped develop Duexis, a combination of two generic drugs used to treat arthritis. He later led La Jolla Pharmaceutical Company and oversaw the approval of Giapreza, a treatment for low blood pressure. While some of the therapies developed under his leadership saw limited commercial success, Tidmarsh has maintained a reputation as a hands-on drug developer who understands the full arc of regulatory science. 

In recent years, he has become increasingly vocal about the need for greater scientific integrity and transparency in research. He has publicly criticized what he sees as systemic failures in academic publishing and has funded a new initiative through Retraction Watch to investigate suspect studies. In a 2023 LinkedIn post, he wrote, “Academic science has become riddled with fraud. The time has come to root out the corruption.” He has also cited the retraction of papers from prominent cancer institutions as evidence of deeper problems within biomedical research. 

Tidmarsh is a contributor to the Journal of the Academy of Public Health, an open-access journal co-founded by Commissioner Makary and current NIH Director Dr. Jay Bhattacharya. The journal has drawn attention for its unconventional peer review model and its ties to prominent critics of pandemic-era public health measures. Tidmarsh has moderated panel discussions on misinformation, censorship, and academic freedom alongside other figures who now hold key federal health leadership roles. 

His appointment comes during a period of significant turnover and restructuring at the FDA. Several longtime regulators have departed in recent months, and CDER faces ongoing challenges related to staffing, advisory committee operations, and review timelines. Tidmarsh has himself been critical of recent FDA decisions, including the accelerated approval of Sarepta’s gene therapy Elevidys. In an April opinion piece, he wrote that former vaccine regulator Peter Marks had “subverted the scientific process at FDA for years.” 

Speaking in an FDA podcast on his first day in the role, Tidmarsh emphasized his commitment to motivating agency staff and outlined a philosophy of flexible, science-based regulation. “In larger populations, of course, you need to demand the strong, irrefutable data of statistical and clinical significance,” he said. “But there’s going to be times where judgment has to come into play, especially for very small populations.” 

As Tidmarsh assumes leadership of CDER, his decisions will carry meaningful implications for the cancer research community. With a growing number of oncology therapies advancing through expedited pathways, his views on scientific standards, regulatory flexibility, and data transparency may influence how future cancer treatments are evaluated and approved. At a time of heightened attention to FDA’s role in drug oversight, the direction CDER takes under his leadership will be closely watched by researchers, clinicians, and patients alike. 

NIH and FDA Announce Plans to Reduce Use of Animals in Research and Encourage New Approach Methodologies 

-David Zahavi, PhD 

Animal models are non-human species that can mimic biological processes or diseases found in humans. They include mice, rats, zebrafish, and other animals that are used in biomedical research to better understand human physiology and disease. By using animal models, researchers have learned an incredible amount about basic and complex biology and have been able to test new therapies and interventions to improve health. About 95% of animals used in research are mice, rats, or other rodents bred specifically for that purpose. Oher mammals, such as primates, together account for less than 1% of all animals used in research. 

The Food and Drug Administration (FDA) and National Institutes of Health (NIH) utilize animal models in various capacities to advance biomedical research and ensure the safety of regulated products. The FDA employs them for pre-market safety and toxicity assessments of new drugs and medicines, while the NIH uses animal models in its own research and also funds grants that utilize animal models for research to better understand disease mechanisms and develop new therapies. The use of non-rodent animal models has been declining, and since 1985, the use of those animals for research has more than halved. Although scientists are continually trying to minimize the use of animals and replace them with alternatives, animal research remains critical and necessary for ethical, safety, legal, and practical reasons when addressing certain scientific questions.   

Recently, both the FDA and NIH have announced a shift in their approach to drug development, preclinical research, and safety testing to increase support for New Approach Methodologies (NAMs) to replace traditional animal models. NAMs encompass a variety of innovative methods that don’t rely on animal models including organoids and microphysiological systems (e.g. “organs-on-chips”), artificial intelligence and computational approaches, advanced in vitro assays, and alternative organisms. The stated goal of promoting the use of NAMs is to create a more ethical, cost-efficient, reproducible, and human-relevant approach to scientific discovery and drug development.  

On April 10, the FDA published a roadmap outlining their plan to reduce, refine, and replace animal testing in preclinical safety studies with scientifically validated NAMs. Their stepwise approach would begin with phasing out the animal testing requirement for monoclonal antibodies due to animal models acting as poor predictors of human safety for this drug class. On July 7, the FDA held a joint workshop with the NIH on reducing animal testing that further detailed the planned implementation of NAMs and other strategies to reduce the use of animal testing. The FDA stated that their encouragement of drug sponsors to embrace NAMs was aimed at reducing animal testing to the extent that it becomes “the exception rather than the norm” within 3-5 years.   

On April 29, the NIH announced their own initiative to prioritize human-based research technologies while reducing the use of animal models. As part of the initiative, NIH intends to establish a new Office of Research Innovation, Validation, and Application (ORIVA) within NIH’s Office of the Director. ORIVA will be charged with coordinating efforts to develop, validate, and scale up the use of NAMs across NIH’s biomedical research portfolio. Then on July 10, NIH further announced that all new Notices of Funding Opportunity (NOFOs) that relate to animal model systems must now also support human-focused approaches such as NAMs and that the NIH will no longer issue NOFOs exclusively supporting animal models or specifying the types of models that must be used. The NIH later clarified that these steps are meant to encourage investigators to choose the best models for their research without constraints and applications that propose research exclusively involving animal models will continue to be supported. 

Overall, the FDA and NIH’s recent announcements represent the latest in a series of actions by the Federal government to promote NAMs in biomedical research and drug development and reduce the use of animal models. While there’s strong enthusiasm from scientists for the potential benefits of NAMs, there has been continued discussion of the challenges to validating and implementing NAMs. As the FDA and NIH’s plans to prioritize human-based technologies continue to evolve, researchers hope to further collaborate with those agencies on the use of NAMs and animal models moving forward.  

Register Now: 13th Annual Rally for Medical Research 

The 13th Annual Rally for Medical Research will be held September 17-18, 2025, in Washington, D.C. The Rally brings together advocates from around the country to call upon the nation’s policymakers to make funding for the National Institutes of Health a national priority and bring attention to the importance of stable and robust investments in medical research. The Rally for Medical Research comes at a crucial time for the medical research advocacy community as the White House has proposed a 40% cut to the NIH budget. The deadline to register for the 13th Annual Rally for Medical Research is September 8. 

Both a participant training and a reception for advocates will be held on September 17, followed by the Rally Hill Day on September 18, in which participants will meet with congressional offices. 

Join the 77% of Americans who oppose medical research cuts by registering for the lobby day and booking your room in the hotel block today. Please contact Rally organizers with any questions. 

AACR Hosts Congressional Briefing on Tobacco Prevention and Cessation Policy 

–Blake William Rostine 

On Wednesday, July 23, 2025, the AACR, in partnership with the American Lung Association (ALA) and the Campaign for Tobacco-Free Kids (CTFK), hosted a Congressional Briefing titled “Tobacco Prevention and Control is a Crucial Strategy in Combating Chronic Diseases.” This widely attended event saw an audience of bipartisan staffers, community leaders, and subject matter experts, all with the hopes of promoting tobacco cessation and prevention efforts and informing the Hill of the dangers of reduced funding for programs that work to combat addiction. 

The panelists, which included the AACR’s Tobacco Products and Cancer Subcommittee Vice Chairperson Suchitra Krishnan-Sarin, PhD, and Member Benjamin A. Toll, PhD, spoke to a bipartisan audience about the importance of federally funded public health programs, such as the CDC’s TIPS From Former Smokers campaign. Attendees were informed about the large-scale health and economic benefits of these resources, and how they work to combat chronic disease.  

The panel also included Dr. Brian King, former director of the FDA’s Center for Tobacco Products, and Sally Herndon, former head of the North Carolina Tobacco Prevention and Control Branch, to speak on the necessity of the CDC’s Office of Smoking and Health (OSH). These panelists spoke to how if we pause the work done by these programs, hundreds of thousands of Americans will continue to become addicted to nicotine every year. Additionally, TIPS speaker Amanda B. and CTFK Youth Ambassador Breanna Cutwright spoke about how these cuts personally impact their work to promote tobacco cessation and how tobacco addiction impacts everyday Americans. 

The AACR looks forward to continuing to work with policymakers, leading experts on addiction, and community leaders to ensure that programs like OSH and TIPS remain funded, so that we can continue the momentum in tackling nicotine and tobacco addiction.  

Register Today: FDA-AACR Workshop: Approach to Novel Oncology Endpoint Development

The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence and the American Association for Cancer Research (AACR) are hosting a hybrid workshop titled “Approach to Novel Oncology Endpoint Development” on Thursday, September 11, 2025, at the Hilton Alexandria Old Town in Alexandria, Virginia.

This workshop will bring together leading experts from FDA, academia, industry, and patient advocacy to examine evolving approaches to endpoint development in oncology drug trials. As cancer research progresses and therapeutic strategies become more targeted, there is an increasing need to reconsider traditional clinical endpoints and define new ones that better reflect meaningful outcomes for patients.

Key workshop themes include:
 • Current challenges and opportunities in validating novel endpoints
 • Use of real-world data and patient-reported outcomes
 • Regulatory and evidentiary considerations
 • Case studies in specific cancer types and trial settings

Participants will gain valuable insight into the scientific, clinical, and policy considerations shaping the future of oncology endpoint development. Registration is now open for virtual and in-person attendance.

 For more details, visit the workshop website.

Recording Available: AACR Patient Advocate Forum: From Discovery to Survivorship: Technology’s Role in Beating Cancer 

On July 15, the AACR Patient Advocate Forum, From Discovery to Survivorship: Technology’s Role in Beating Cancer, brought together advocates and researchers from around the world to discuss how cutting-edge technologies are transforming cancer research and care. Moderated by AACR SSP Founder Dr. Anna Barker and featuring leaders from Stanford, MIT, and the Mayo Clinic, the forum explored innovations in immunotherapy, precision oncology, imaging, and survivorship. 

Watch the recording.

The FDA Oncology Drugs Advisory Committee Reiterates Importance of Optimized Dosages and U.S. Representative Populations 

-Brad Davidson, PhD 

The Food and Drug Administration (FDA) Oncology Drug Advisory Committee (ODAC) undertook the evaluation of the benefit/risk ratio of belantamab mafodotin in two different indications on July 17. At the end of discussions, the committee voted against the favorability of both indications, which were for pre-treated multiple myeloma patients and in combination with two separate previously approved therapeutics.  

Belantamab mafodotin previously received accelerated approval in August 2020 as a monotherapy in heavily pretreated patients with multiple myeloma, but was withdrawn two years later after its confirmatory trial, DREAMM-3, failed to show statistically significant improvements in efficacy over standard of care. The discourse of the recent meeting didn’t center on efficacy, as the DREAMM-7 and DREAMM-8 trials supporting the new proposed indications met their efficacy endpoints. Instead, both trials were criticized for high rates of ocular toxicity and dose modifications, possibly suggesting a poorly optimized dosage, and low U.S. patient enrollment, particularly in disease-relevant populations. One point in favor of Belantamab mafodotin was the unmet need for new treatments in this setting, which was echoed by many of the public commenters.  

This treatment now awaits formal decisions by FDA, as all decisions made by the committee are highly influential but non-binding. The issues presented in this case are, however, current points of major interest for FDA. FDA OCE’s Project Optimus recently crested five years of operation, and highlights the need for the investigation of optimized, often lower, doses in oncology trials. Additionally, OCE’s recent multi-regional clinical trial guidance and the introduction of Project Site Selector outline FDA’s need for trials to be representative of U.S. populations in order to substantiate approval.  

FDA Releases Draft Guidance on the Development of Novel Drug Combinations 

-Brad Davidson, PhD 

On July 17, the FDA Oncology Center of Excellence (OCE) released a draft guidance titled “Development of Cancer Drugs for Use in Novel Combination—Determining the Contribution of the Individual Drugs’ Effects Guidance for Industry,” which provides recommendations for drug sponsors to consider when characterizing the safety and efficacy of novel combination therapies. This guidance expands on a 2013 guidance on the development of combinations which wasn’t specific to oncology drugs. Its purview includes recommendations for the codevelopment of investigational drugs, the combination of an approved drug in a novel indication with investigational drugs, and novel combinations of drugs already approved in different indications.

According to the guidance, the novel combination of drugs is best when there is a necessity of each in the combination, based on biologic rationale, nonclinical data, and early clinical evidence. During development, the safety and effectiveness of the individual drugs, in addition to their combination, must be evaluated to verify the potential benefit of combination and possible potentiation of toxicities. In most cases, factorial studies, where each drug is evaluated alone or in combination with standard of care in addition to in combination, were outlined as the favored approach. The guidance particularly highlights the usage of randomized adaptive factorial designs, wherein ineffective treatment arms can be dropped.   

It was also highlighted that external data, including previous clinical trial data, may be able to provide evidence for contribution of the effect of each therapeutic when the effect of combination is expected to be large, is backed by clear biological rationale, where the natural history of the disease being studied is highly predictable, or where monotherapy has displayed little clinical activity. Generally, high quality patient-level data will be required to serve in this capacity, but data from trials in the same indication, alternative indications, real-world data, and in some instances even summary-level data may be applicable.    

The FDA is accepting comment on this draft guidance until September 15, 2025.  

Oncology Approval Recap  

-Brad Davidson, PhD  

Between June 26 and July 24, the U.S. Food and Drug Administration (FDA) granted two approvals for novel oncology products, both through the accelerated approval process.  

  • Linvoseltamab-gcpt received accelerated approval for adults with relapsed refractory or multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This is the first approval for this bispecific T-cell engager, which uses a response-adaptive dosing regimen. This application was granted priority review, and received orphan drug and fast track designations.  
  • Sunvozertinib received accelerated approval for adults with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. This is the first approval for this agent, which also constitutes the first approval of an EGFR exon 20 targeting drug in the first-line in this setting. This application was granted priority review, and received the breakthrough therapy designation.