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Cancer Policy Monitor: October 13, 2026

2026 Rally for Medical Research Hill Day Draws Hundreds of Advocates

–Matt Gontarchick

Medical research advocates from across the country gathered in Washington, D.C., September 16-17 for the 14th annual Rally for Medical Research. The American Association for Cancer Research (AACR), the founding organizer and a lead sponsor of the rally, joined over 400 partner organizations to advocate for robust, sustained, and predictable funding increases for the National Institutes of Health (NIH).

Patient advocates, caregivers, researchers, and health professionals gathered for a reception in the Dirksen Senate Office Building on Capitol Hill on September 16, featuring remarks from AACR CEO Margaret Foti, PhD, MD (hc); AACR President Keith Flaherty, MD; NIH Director Jay Bhattacharya, MA, MD, PhD; AACR Chief Policy Officer Jon Retzlaff, MBA, MPA; Manesh Panesh, MD, Volunteer President, American Heart Association; Senator Dick Durbin (D-IL); Kate Klimczak, President, ACT for NIH; and Reed Jobs, founder, Yosemite. The reception also featured video remarks from former Senator Ben Sasse (R-NE), who is currently undergoing treatment for pancreatic cancer.

On September 17, nearly 300 advocates representing 30 states took part in more than 200 meetings with their members of Congress and staff. Participants advocated for Congress to provide at least $51.3 billion for the NIH base budget in FY 2027, consistent with the medical research community’s recommendation. Advocates also urged Congress to prevent OMB from finalizing or implementing proposed grantmaking changes that would undermine scientific merit review. Advocates and partner organizations also participated in a National Day of Action on September 17, amplifying the rally message via social media and email campaigns. The Rally for Medical Research initiative was launched in April 2013 to bring together the entire medical research community to ask Congress to make the NIH a national priority. Through the annual Hill Day, the Rally for Medical Research continues to raise awareness about the critical need for increased investment in NIH to improve health, spur progress, inspire hope, and save more lives. See the list of the Rally partner organizations.

AACR Releases 16th Edition of Landmark Cancer Progress Report

On September 16, AACR proudly unveiled the 16th edition of the Cancer Progress Report, a cornerstone report to increase the public’s understanding of the strides made in cancer research, as well as opportunities for policymakers to bolster this lifesaving work. Highlighting the advances in basic, translational, and clinical cancer research, while sharing the inspirational stories of patient-advocates, the report is essential in ensuring that the U.S. maintains its momentum in the fight against cancer.

To commemorate the report, AACR held a congressional briefing in Washington, D.C., where panelists, including patient-advocates featured in the report, AACR President Keith Flaherty, MD, and Catherine Bollard, MBChB, MD, spoke to the impacts of the report and cancer research. This briefing also featured remarks from Senator Shelley Moore Capito (R-WV) and Congressman James Walkinshaw (D-VA), who spoke to the bipartisan support cancer research has and how this remains a priority for Congress. The report garnered nationwide media attention, with outlets like CBS News relaying the findings to thousands of viewers.

A recording of the briefing is available, while the full report can be accessed online.

Trump Administration Reportedly Considers New Oversight of NIH Grantmaking

–David Zahavi, PhD

In mid-September, the Trump administration was reportedly considering a new executive order that would establish a panel with authority to review and approve or reject National Institutes of Health (NIH) grants. According to multiple reports, President Trump met with Office of Management and Budget (OMB) Director Russell Vought and NIH Director Jay Bhattacharya on September 18 to discuss additional scrutiny of NIH grantmaking. Following the meeting, Vought was directed to develop an executive order that would establish a panel that could review NIH grant awards before they are funded and ensure they align with the administration’s political ideology. The proposed panel would reportedly include Vought and Bhattacharya and would require unanimous agreement to approve awards. The proposal remains under development, and the White House, OMB, and NIH have not publicly announced details.

The proposed review panel comes amid a broader series of actions that have increased the role of politics in federal research funding decisions. In 2025, NIH terminated or paused grants involving topics including diversity, equity, and inclusion (DEI) and health disparities as well as instituted screening of grants for terms disfavored by the administration. More recently, on September 16 a coalition of researchers filed a federal lawsuit alleging that NIH is using a list of 235 keywords such as “equity,” “advancing diversity,” “racist,” “gender,” “Latinx,” and “climate change” to identify grant applications and active awards for additional scrutiny and termination. Importantly, on May 29, OMB released their proposed “Regulation for Federal Financial Assistance” which would substantially change the government-wide framework for awarding and managing federal grants. Among other provisions, the proposal would require senior political appointees to conduct pre-issuance reviews of all awards, apply considerations including whether awards advance the President’s policy priorities, and order political appointees to use independent judgment rather than routinely deferring to scientific merit review recommendations. Congress subsequently enacted a provision temporarily blocking OMB from finalizing or implementing the proposed rule through December 11, 2026. The reported executive order is yet another effort to radically change the federal research funding process and establish greater political oversight, and could represent an effort to establish political review of NIH grants through a separate mechanism if the OMB regulation is ultimately blocked or prevented from taking effect.

The potential executive order drew swift bipartisan pushback from Congress. Senior Congressional appropriators on both sides of the aisle including, Senate Appropriations Committee Chair Susan Collins (R-ME), Vice Chair Patty Murray (D-WA), and House Appropriations Committee Ranking Member Rosa DeLauro (D-CT), all issued statements urging the administration not to impose new political controls on NIH grantmaking. Collins subsequently sent a September 22 letter to OMB Director Vought and NIH Director Bhattacharya warning that a political review layer would undermine the merit-review process and appear to circumvent congressional action blocking the OMB grantmaking proposal. Recent reporting indicates that the administration is backing away from its initial plan to issue the executive order following the congressional opposition, although officials are reportedly considering a modified approach and the White House has not confirmed that the executive order will be abandoned.

NIH Extends Modified Peer Review Practices Through January 2027

–David Zahavi, PhD

NIH announced on September 8 that the modified peer review procedures implemented following the 2025 lapse in federal appropriations will remain in place through the January 2027 Advisory Council round. NIH initially modified its peer review process to address the backlog of applications created when hundreds of review meetings were canceled during the funding lapse. The modified peer review practices include a reduction in the number of applications discussed in review meetings from the typical 50% to approximately 30-35% of applications, designation of applications in the middle third of scores as “competitive but not discussed” but eligible for funding consideration while applications in the lowest third will be designated “not competitive and not discussed,” and use of simplified summary statements that omit narrative summaries of committee discussion and instead provide a statement describing the degree of consensus and bullet points identifying the primary factors driving scores. Discussed applications will continue to receive overall impact scores, along with written critiques from assigned reviewers. NIH said the continued modifications are necessary because of an unprecedented volume of applications currently under review. NIH reported that more than 35,000 grant applications were scheduled for review at the January 2027 Advisory Council, already exceeding the record 33,640 applications reviewed for the May 2026 Council.

The extension of modified peer review practices comes amid the ongoing NIH proposal to change how peer review outcomes are reported to investigators and institutions. In the August 14 Request for Information, NIH proposed replacing reporting of numerical overall impact scores and percentile rankings with three broad categories: “Most Competitive” for the top 25th percentile, “Competitive” for applications between the 26th and 50th percentile, and “Not Discussed” for applications in the bottom 50th percentile. The numerical overall impact scores and percentile rankings would no longer be available to the principal investigator(s), applicant institution, NIH program staff, ICO leadership, or relevant NIH Advisory Council. The proposal is part of NIH’s Unified Funding Strategy, which intends to place greater emphasis on considering peer review results alongside scientific priorities, strategic plans, workforce needs, available funding, and the broader research portfolio. NIH is accepting public comments on the proposed changes to peer review outcome reporting through October 13, 2026. Researchers and other stakeholders are encouraged to review the RFI and submit responses before the deadline.

Multi-Cancer Early Detection Test Endorsed by FDA Advisory Committee

–Brad Davidson, PhD

On September 23, the FDA Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee held a meeting to discuss whether the GRAIL Galleri test is safe and effective, and whether the benefits of its use outweighed the risks for use in cancer screening for adults 50 or older.

The data evaluated by the committee to arrive at these determinations were the PATHFINDER 2 and NHS-Galleri clinical trials. The PATHFINDER 2 study was a single-arm study performed throughout the United States where all patients were tested, while the NHS-Galleri study was performed in the United Kingdom and compared outcomes in individuals who added Galleri testing versus those who were not tested. Notably, the NHS-Galleri trial missed its planned endpoint of a reduction in the diagnosis of stage 3 or stage 4 cancers. However, the test was able to detect many cancers that currently have no recommended screening tests.  

Many notable figures in cancer research spoke at the hearing, including Phil Castle, PhD, director of the Division of Cancer Prevention at the NCI, and William Dahut, MD, chief scientific officer at the American Cancer Society. The testimony of these individuals during the open public hearing encapsulated much of the concerns of the committee. Castle outlined that the trials demonstrate some sensitivity for late-stage cancers, but early-stage sensitivity remains poor. Indeed, the committee deliberated at length regarding whether these tests can be called “multi-cancer early detection tests,” favoring instead “multi-cancer detection tests.” He also highlighted how these tests have not yet shown any clinical benefit, since they did not shift more cancers to being detected earlier and decreases in mortality have yet to be seen. Meanwhile, Dahut focused on the patient impact these tests can have today, especially in cancers that have no other screening options. This was echoed by multiple patients who credited the test with detecting their cancer and saving their lives. He also outlined how Galleri statistically outperforms other similar screening tests that are already in regular use, such as mammography.

Other significant concerns of the committee included that the test fails to detect a significant number of cancers that are present, meaning that those with negative results may still have cancer. Despite data from clinical trials indicating that individuals receiving Galleri testing also sought out other recommended cancer screening tests, the panel was also concerned that individuals would forgo other tests because of their Galleri results.

In the end, the panel voted in favor on all counts, albeit narrowly in some cases. All 10 members voted to indicate the test’s safety, the vote was split 6-4 regarding its efficacy, and seven members voted in favor of it having a positive benefit-risk ratio with two against and one abstention. Notably, the committee echoed that while the risks of the test are low, the benefits remain murky, and future studies are needed to determine whether the tests truly provide clinical benefit. The FDA will now take the committee’s decisions into account as it considers the tests for FDA approval over the coming months. While the FDA is not required to agree with the committee, it often does so. If approved, as a result of the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act, the test will be subject to a review by the Centers for Medicare and Medicaid Services (CMS) before being covered broadly. Another pathway for broad coverage would be if the tests were recommended by the United States Preventive Services Task Force (USPSTF).

FDA Leadership Selections Move Forward, with Center Directors Formalized and Commissioner Candidate Heidi Overton Nomination Hearing

–Brad Davidson, PhD

After a year and a half period where there was a new director at one of the FDA’s major centers nearly every month, frequent leadership turnover may be coming to an end. Acting Director of the Center for Drug Evaluation and Research (CDER) Michael Davis, MD, PhD, Acting Director of the Center for Biologics Evaluation and Research (CBER) Karim Mikhail, and Acting Director of the Center for Tobacco Product, Bret Koplow, PhD, JD, were all given the nod to become the permanent directors of their respective institutions this September. This adds to a leadership group including Angelo de Claro, MD, who was upgraded from acting director to director of the Oncology Center of Excellence in the spring, as well as Michelle Tarver, MD, PhD, who has been the director of the Center for Devices and Radiological Health since 2024.

Meanwhile, Heidi Overton, MD, PhD, faced her nomination hearing as the candidate for the role of the next commissioner of the FDA in front of the U.S. Senate Committee on Health, Education, Labor, and Pensions on September 24. Overton is currently the deputy assistant to the president for domestic policy, where she advise the president on health policy issues. If confirmed, she would lead an agency that has been subject to significant controversy in the last two years, driven by significant political interference in a traditionally science-led agency. Among the many issues currently facing the agency are significant decreases in staffing as a result of reductions in force and subsequent voluntary departures, increasing authorizations and permissiveness towards flavored e-cigarette products, uncertainty regarding the regulation of vaccines, delayed studies on the abortion drug mifepristone, increasing food recalls, and worries that China is overtaking the U.S. in biomedical and clinical research. Each of these areas were topics of robust discussion by the Senators. For her part, Overton indicated some degree of support for vaccines. She believes the MMR vaccine, the subject of a recent executive order that sought to create individual vaccines for the three conditions it covers, is safe and effective. However, when asked if the President was incorrect when he recently said that this vaccine was “lethal” to children, she did not provide a clear answer. She voiced that the administration seeks to keep illegal, foreign, flavored e-cigarettes out of the hands of children, pushed back on multiple senators who asked whether the President has financial conflicts of interest regarding recent FDA decisions that have made these products significantly more accessible to children. When asked if she would resume FDA advisory committees, which have been significantly reduced since 2025, she indicated that they were important but did not indicate that she would reinstate committees that have been disbanded or encourage more meetings. Overton’s nomination will be voted on by the subcommittee in the coming days, and if advanced from this committee will be the subject of a whole-Senate vote prior to potentially assuming the role of Commissioner of the FDA.

Operation Trialblazer Actions Continue to Take Shape at FDA

–Brad Davidson, PhD

In June, Operation Trialblazer was announced to much excitement within the drug development community, with the intent to “strengthen America’s leadership in clinical research, accelerate the development of lifesaving treatments, and ensure that patients have access to the most innovative therapeutics in the world.” This came against a backdrop of concerns that the U.S. is losing its longstanding leadership in clinical research to other countries, namely China and Australia, as a result of rules and regulations being more difficult and more expensive to navigate stateside. Among the many efforts slated as part of this effort to bring clinical trials back to the U.S., several were to be led by the U.S. FDA.

Namely, two of the clearest and most easily implementable prongs of Operation Trialblazer were to shorten the time it takes for therapeutics to receive their Investigational New Drug (IND) authorization, allowing clinical studies of a novel therapeutic to begin in humans for the first time, and greater implementation of new approach methodologies to establish the safety of these products instead of more costly and sometimes less directly human-relevant animal models. In support of these efforts, FDA issued a direct final rule that updated its regulations to substitute references to “animal,” “preclinical,” and “in vitro” studies with “nonclinical” studies. This is language that FDA has been using informally for years to signal its openness towards alternative methods, especially to determine the safety of new medical products, and it aligns with the Food and Drug Omnibus Reform Act of 2022, which encouraged the use of validated new approach methodologies in place of animal studies where appropriate. Additionally, FDA launched its Expedited IND pilot program, which seeks to build capacity and work out any challenges as the agency works to decrease the amount of time required to issue new IND authorizations. Specifically, this program pairs a company with a leading academic research institution in hopes of smoothing a transition towards rolling review of IND applications. FDA plans to accept up to 10 applications from research institute-industry organization pairs to participate in an initial cohort. The application will be open until October 30.

Oncology Approval Recap

Between August 28 and September 24, FDA issued five approvals for oncology drug products.

  • Belzutifan was approved in combination with lenvatinib for adults with advanced renal cell carcinoma with a clear cell component following treatment with a programmed death receptor (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.
  • Lirafugratinib was approved for the treatment of adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma harboring a fibroblast growth factor receptor 2 (FGFR2) gene fusion or other rearrangement. This application was granted priority review and lirafugratinib received breakthrough therapy and orphan drug designations.
  • Camizestrant, in combination with a CDK4/6 inhibitor, received accelerated approval for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer upon detection of an estrogen receptor-1 (ESR1) mutation during aromatase inhibitor and CDK4/6 inhibitor therapy. This application was the subject of a recent meeting of the FDA Oncologic Drugs Advisory Committee, where the committee voted 6-3 that the benefit-risk profile of switching to camizestrant based on a molecular marker instead of at the traditional timepoint of progression was unfavorable. However, given positive-trending overall survival results and clear improvements in progression-free survival, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) offered a positive opinion, leading to EMA approval for this treatment paradigm in July. Review was conducted under Project Orbis, in collaboration with the Australian Therapeutic Goods Administration, the Brazilian Helath Regulatory Agency, Health Canada, Singapore’s Health Sciences Authority, and Swissmedic. Camizestrant also received breakthrough therapy designation.
  • Sevabertinib was granted accelerated approval for adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with HER2 tyrosine kinase domain activating mutations. This is an expansion of a previous accelerated approval in the same setting that additionally required patients to have received prior systemic therapy. Review was conducted under Project Orbis, in collaboration with the United Kingdom’s Medicines and Healthcare products Regulatory Agency. This application was granted priority review, and sevabertinib received breakthrough therapy and orphan drug designations.
  • Imlunestrant was approved in combination with abemaciclib for adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. This drug was previously approved in this setting without the addition of abemaciclib.