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Cancer Policy Monitor: September 8, 2026

AACR to Release Latest Cancer Progress Report on Capitol Hill

To highlight the strides and achievements made by the cancer research community, the American Association for Cancer Research (AACR) will proudly unveil the latest edition of the Cancer Progress Report on September 16, 2026, in Washington, D.C. This report is a powerful testament to how sustained investment in cancer research saves lives. This report highlights the groundbreaking advances of the past year and the essential relationship between Congress and the cancer research community, leading to lifesaving advancements. Included in this report are bipartisan Congressional features, highlighting Congress’ dedication to supporting America’s mission to end cancer.  

Registration for the event is now available. A recording of this event will be available at a later date.   

House Passes CR, Temporarily Blocking OMB Proposal  

–Blake William Rostine

On September 1, the US House passed a Senate-approved continuing resolution (CR) that would fund federal agencies through December 11. This bill will now go to President Trump, and must be signed by September 30, to prevent a government shutdown. Importantly, this CR also temporarily blocks passage of the OMB rule which would fundamentally change the process for research grants and cooperative agreements.  

This OMB proposal would impact the awarding and administrative process for grants across all federal agencies, including provisions that would allow for termination of grants for reasons not related to performance or scientific merit and undermine peer review and international research collaboration. 

AACR commended the Senate for including language in their CR to prevent passage of the OMB and called on the House to approve the measure. However, AACR will continue to advocate for withdrawal of the proposal in its entirety, as it stands to threaten the progress in the cancer research community and medical research as a whole.  

NIH Proposes Changes to Grant Score Reporting Following Peer Review 

–David Zahavi, PhD

On August 14, The National Institutes of Health (NIH) formally announced a proposal to significantly change how the results of grant application peer review are reported to investigators and NIH staff. Under the current system, NIH reviewers assign applications numerical overall impact scores using a 1-to-9 scale, with lower scores reflecting stronger assessments of scientific merit. Discussed applications receive a final overall impact score, calculated from the scores assigned by eligible members of the review panel, while many applications also receive a percentile ranking that compares their score with those of applications reviewed by the same study section over the last three review cycles. Percentiles can help account for differences in scoring practices among review panels and provide investigators with additional context about the competitiveness of their applications. The overall impact score and percentiles are then provided both to the applicant and their institution as well as NIH program staff and advisory councils to help guide funding decisions. 

Under NIH’s proposal, the underlying peer review process would remain largely unchanged, including the use of numerical scores by reviewers. However, final overall impact scores and percentiles would no longer be reported to principal investigators, applicant institutions, NIH program staff, Institute and Center leadership, or advisory councils. Instead, applications would be placed into one of three categories: “Most Competitive,” representing the top 25% of discussed applications; “Competitive,” representing applications in the 26th through 50th percentiles; or “Not Discussed,” for applications falling below the 50th percentile. 

The proposal is part of NIH’s broader Unified Funding Strategy, which intends to move away from relying primarily on numerical paylines when developing funding plans. A working group of NIH leaders was charged in 2025 with recommending changes in NIH reporting of peer review evaluations to facilitate the Unified Funding Strategy, however there is no information on who took part in this working group or on the decision-making process. NIH argues that the changes would reduce an overemphasis on numerical scores and encourage funding decisions that consider the full range of peer review information alongside scientific priorities, strategic plans, workforce needs, and available funding. NIH also held a public webinar, “Understanding NIH’s Unified Funding Strategy: What the Research Community Needs to Know,” in which agency leaders discussed the strategy’s rationale, goals, and implementation and addressed questions from the research community. NIH leadership emphasized that, moving forward, program officials would be increasingly relied upon to utilize their substantial expertise, portfolio analyses, and judgment to make award recommendations. 

The proposal has raised concerns that eliminating the reporting of overall impact scores and percentiles would further reduce transparency into the grant funding process, at a time when the Office of Management and Budget has also proposed numerous changes to how grant review is conducted. Simply bucketing grants into broad categories such as “Most Competitive” would encompass numerous applications with potentially meaningful differences in peer review scores and provide program staff with less information about how applications performed relative to others. In addition, without a percentile ranking, investigators may also have greater difficulty comparing results across review panels or assessing the competitiveness of their revised applications. The proposal would ultimately make it more difficult for applicants to understand their likelihood of funding, plan future submissions, and evaluate exactly how NIH programmatic considerations influenced funding decisions. 

NIH is seeking public comment on the proposed changes through an open Request for Information and feedback can be submitted through October 13, 2026.

NIH Reportedly Limiting Policy-Focused Research 

–David Zahavi, PhD

Recent reporting has raised new concerns that the National Institutes of Health (NIH) may have begun screening grant applications for whether they involve any research related to public policy or the health effects of public policy. According to Nature, political appointees at NIH have been flagging grant applications focused on policy or that contain the word “policy” or related terms for those portions to be removed or, in some cases, freezing grant applications entirely.  

Science and health policy are important components of public health and medical research. Studies examining the effects of policies on health can help researchers understand how factors such as insurance coverage, tobacco control measures, environmental regulations, access to preventive services, and other interventions affect cancer risk and patient outcomes. Restricting such types of research would limit efforts to understand how public policies influence cancer prevention, early detection, access to treatment, and cancer disparities. However, internal documents appear to show a shift in NIH to no longer consider policymakers as a stakeholder group within the scope of NIH’s mission. 

The reports come amid ongoing broader changes to the federal research funding process that have increased concerns about political influence over scientific decision-making. The Office of Management and Budget proposal included provisions to bar federal funding for anything that advocated for or against public policy in very broad terms. Although the proposed continuing resolution to fund the federal government includes a provision block implementation of the OMB rule until at least December 11, NIH may have begun implementing some parts of that proposal. NIH has previously faced scrutiny over the cancellation or disruption of grants involving topics viewed as inconsistent with administration priorities. More recently, research examining the effects of discrimination and other social factors on health has faced additional funding disruptions, highlighting concerns that political considerations rather than scientific merit are increasingly effecting funding decisions. 

NIH has not publicly released a detailed policy or statement describing how applications involving “policy” are being identified or evaluated, leaving researchers with unanswered questions about the scope of the reported review process and its potential impact on pending applications. Scientific progress that benefits all patients must include research that investigates how policies affect health and cancer outcomes and generates the evidence needed to inform effective prevention, treatment, and public health policy. 

NIH Could Restrict K99/R00 Awards to U.S. Citizens 

–David Zahavi, PhD

NIH is reportedly considering a policy change that would restrict eligibility for its Pathway to Independence Award, known as the K99/R00, to US citizens. The proposal represents a significant departure from current policy, under which there is no citizenship requirement for K99 candidates and scientists on temporary visas are eligible to apply for K99/R00 awards provided they meet applicable visa requirements. The K99/R00 program is an important mechanism for helping promising postdoctoral researchers transition to independent research careers. Restricting the program to US citizens would limit opportunities for international scientists training in the US and further complicate efforts by cancer research institutions to recruit and retain early-career talent.  

The potential change has raised concerns that immigration restrictions and uncertainty surrounding federal research funding could weaken the US medical research workforce and encourage highly trained scientists to pursue opportunities elsewhere. Ultimately, a sustained reduction in the number of international scientists entering the US research workforce could significantly diminish scientific capacity and research output, with one analysis estimating that a one-third decline in graduate student enrollment would shrink the PhD-level workforce by 11.4% and result in hundreds of billions of dollars in economic losses. NIH has not yet formally announced a policy proposal or implemented changes, however a reduction in international scientists’ ability to be trained in the US has been a policy priority of the current administration. 

Heidi Overton to be Nominated for Commissioner of the US Food and Drug Administration 

–Brad Davidson, PhD

President Trump announced on August 19 that he intends to nominate the White House deputy director of domestic policy, Heidi Overton, MD, PhD, to be the next commissioner of the U.S. Food and Drug Administration. She would take over from Acting Commissioner Kyle Diamantas, JD, who has led the agency since the departure of Marty Makary, MD, in mid-May.  

Overton has been part of both Trump administrations and worked with Makary during her surgery residency at Johns Hopkins. During her current stint at the White House, she has worked closely with the Department of Health and Human Services and been involved in efforts to overhaul US dietary guidelines and the childhood vaccine schedule. She was present for the signing of and was supportive of a recent executive order that continues Administration attempts to revise vaccine recommendations based on consultation with presidential advisors and a comparison with other countries’ recommendations, instead of the scientific and evidence-grounded approach that has traditionally governed federal vaccine recommendations.  

In order to be confirmed, Overton will need to be advanced to, and subsequently be approved by, a full-Senate vote. This is dependent on passing an initial vote by the US Senate Committee on Health, Education, Labor, and Pensions, chaired by Sen. Bill Cassidy (R-LA). Sen Cassidy expressed strong concerns about Overton’s nomination due to “her lack of managerial experience” and her role in recent vaccine policy changes. However, Cassidy has raised similar concerns about previous Trump Administration nominees for health agencies before voting in favor of their confirmation. A hearing date for Overton to appear before this committee has not yet been scheduled.

FDA Releases Proposed PDUFA VIII Commitment Letter

–Brad Davidson, PhD

Since 1992, pharmaceutical and biotechnology companies have partially funded the US Food and Drug Administration through user fees that they pay upon submitting applications to the agency for the approval of new medicines under the auspices of the Prescription Drug User Fee Act (PDUFA). Prior to 1992, it was common for the review of a new therapeutic to take more than two years, and many therapies were first approved outside of the US. Now, thanks to the increased resources provided by this law, FDA generally takes action on new therapeutics within 10 months of submission to the agency and the majority of novel medicines are approved in the US first. This is particularly true for cancer therapeutics.  

PDUFA expires and is reauthorized every five years, with the next reauthorization set to take place in 2027 with PDUFA VIII. Ahead of each new authorization, industry sponsors and FDA negotiate new parameters for the bill, outlining new provisions to accelerate the development of safe and effective drugs and removing or modifying programs from previous versions that may not have had their intended effect. FDA recently released their commitment letter, a result of these negotiations that outlines what FDA and industry have agreed on for the next iteration of the bill. While many changes are posited, the letter focuses on programs such as streamlining various meetings with industry, restaffing the FDA after workforce losses in 2025, and support for real-world evidence, model-informed drug development, and rare disease endpoint initiatives, among other topics.      

FDA will hold a hybrid public meeting to discuss this letter on September 16, 2026, and comments can be submitted for consideration by October 16, 2026. After finalization of the letter, Congress will be tasked with reauthorization by September 30, 2027, when the current PDUFA VII expires.

Patient Advocates at the 19th AACR Conference on the Science of Cancer Health Disparities  

Patient advocates attending the 19th AACR Conference on the Science of Cancer Health Disparities, October 18-21, 2026, in Atlanta, Georgia, are invited to participate in two roundtable lunch discussions focused on cancer screening and early detection. These interactive sessions will provide opportunities to engage with peers and experts on challenges, emerging advances, and strategies to improve equitable access to screening and early detection across diverse communities. 

Additional details on the roundtables and other patient advocate activities will be announced soon. 

Learn more online.

Application Open: Advocate Partners Pavilion at AACR Annual Meeting 2027 

AACR is now accepting applications for the Advocate Partners Pavilion at the AACR Annual Meeting 2027, taking place in Orlando, Florida, April 2-7, 2027. 

Accepted organizations will receive complimentary exhibit space to showcase their mission, resources, and programs to thousands of attendees at the world’s premier cancer research meeting. Space is limited and applications will be reviewed on a rolling basis. 

For more information, contact [email protected]. 

Apply online and learn more.

Application Open: Scientist↔Survivor Program® 2027 

AACR is now accepting applications for the Scientist↔Survivor Program® (SSP) at the AACR Annual Meeting 2027, taking place in Orlando, Florida, April 2-7, 2027. 

The SSP is a unique educational and advocacy program that brings cancer patient advocates and researchers together to foster collaboration, learning, and dialogue. Participants engage in specialized educational sessions, attend scientific presentations, and gain deeper insight into the cancer research process while sharing the patient perspective with the research community. 

For more information you can contact [email protected]. 

Apply online and learn more.

Oncology Approval Recap 

–Brad Davidson, PhD

Between July 24 and August 27, FDA approved two novel therapeutics, alongside three new indications for previously approved drugs.   

  • Daraxonrasib was approved for the treatment of adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy. Daraxonrasib was granted breakthrough therapy and orphan drug designations, received priority review for this indication, was reviewed under the Commissioner’s National Priority Voucher pilot program, and approved 6.5 months ahead of its due date. 
  • Zanidatamab-hrii was approved as a first line-treatment for adults with unresectable locally advanced metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma in two indications: in combination with fluoropyrimidine and platinum-containing chemotherapy and tislelizumab-jsgr for adults with HER2-positive (IHC3+ or IHC2+/ISH+) disease, and in combination with fluoropyrimidine and platinum-containing chemotherapy for adults with HER2-positive disease (IHC 3+). Review was conducted under Project Orbis in collaboration with Health Canada and the United Kingdom’s Medicine and Healthcare products Regulatory Agency (MHRA).  
  • Iberdomide was granted accelerated approval in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent. Review was conducted under Project Orbis in collaboration with Swissmedic. Iberdomine received breakthrough therapy and orphan drug designations, and this application was granted priority review.  
  • Vusolimogene oderparepvec-wtpg was granted accelerated approval in combination with nivolumab for the treatment of adults with unresectable advanced cutaneous melanoma who experienced disease progression on a PD-1-blocking antibody based regimen. This indication was the subject of a July 30, 2026, meeting of the FDA Cellular, Tissue, and Gene Therapies Advisory Committee, where the committee voted 10-3 in favor of the efficacy results of its supporting trial being evaluable and clinically meaningful. Vusolimogene oderparepvec-wtpg was granted breakthrough therapy designation.  
  • Lutetium Lu 177 vipivotide tetraxetan was approved in combination with androgen receptor pathway inhibitor therapy for adults with prostate-specific membrane antigen-positive metastatic androgen pathway modulation-naive or -sensitive prostate cancer. Review was conducted under Project Orbis in collaboration with MHRA.