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Cancer Policy Monitor: November 11, 2025

Appropriations Progress Amid Shutdown Endgame

-Carly McCallie

On Sunday, November 9, in a late night 60-40 vote, the Senate agreed to take up a House vehicle for a broader agreement to reopen the government. Eight Democrats joined most Republicans to clear the procedural hurdle. The framework promises a mid-December Senate vote on extending expiring Affordable Care Act tax credits, reinstates federal workers laid off at the start of the shutdown, guarantees back pay, and pauses new reductions in force at least through January 30. The House will need to return to pass the package.

As part of the emerging deal, senators also released text for a three-bill minibus that would fully fund Military Construction–Veterans Affairs (VA), Agriculture and U.S. Food and Drug Administration (FDA), and the Legislative Branch for fiscal year (FY) 2026. Remaining agencies would be covered by a continuing resolution through January 30. The timeline is not entirely locked. Some senators are seeking amendment votes and some progressives oppose proceeding without a guaranteed subsidy extension, but leaders signaled intent to finish this week and send the package to the House.

The October shutdown effects were immediate and harmful. Peer review was postponed, new awards could not be processed, and most intramural research paused. Clinical care continued for patients already enrolled in NCI-sponsored trials, but many new enrollments were restricted to emergencies. Reopening would end the freeze, but backlogs and scheduling gaps will continue to slow work that saves lives.

Appropriations progress earlier this year remains key to the path forward. On July 31, the Senate Appropriations Committee advanced its FY 2026 Labor, Health and Human Services, Education, and Related Agencies bill on a 26 to 3 vote, rejecting proposed 40% cuts to the National Institutes of Health (NIH) and providing a $400 million increase overall, including $150 million for the National Cancer Institute (NCI). The bill also included language to block further expansion of forward funding unless FY 2024 grant volume is preserved. In early September, the House Appropriations Committee advanced a smaller NIH increase and proposed a cap on certain indirect costs that research stakeholders warned would damage capacity. These positions remain the bookends for final negotiations once the government is reopened.

If the Senate completes action in the coming days and the House returns to pass the agreement, the NIH can restart peer review, award processing, and intramural operations. FDA would operate under full-year funding through the agriculture bill, stabilizing programs that indirectly affect research and patient care. The continuing resolution date of January 30, however, means the sector will be operating on a short leash for most Health and Human Services agencies until a final LHHS bill is enacted.

In sum, the Senate’s action marks a concrete step toward ending a damaging and historic shutdown and getting research operations running again. It is not a final answer on NIH and NCI funding or health coverage. The medical research community gains near-term relief if the House follows suit, then faces a tight January deadline to secure a full-year LHHS agreement that protects lifesaving research and patient access.

AACR to Release Inaugural Pediatric Cancer Progress Report on Capitol Hill on December 4

-David Zahavi

The American Association for Cancer Research (AACR) will release its first ever edition of the Pediatric Cancer Progress Report on December 4 on Capitol Hill in Washington, D.C. The location and time of the release are forthcoming. This inaugural report will provide 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 will also highlight ongoing and emerging trends in the field, the needs of pediatric cancer survivors, and the global landscape of pediatric cancer.

Please save the date for this landmark report.

FDA Recommends Genetic Screening Before Xeloda Treatment Following AACR Workshop

-Brad Davidson, PhD

In 2020, U.S. Food and Drug Administration (FDA) received a Citizen’s Petition from a patient advocate with support from a group of experts in dihydropyrimidine dehydrogenase (DPD) deficiency and pharmacogenomics that called for updates to the drug labels of fluoropyrimidine chemotherapies. Earlier that year, the European Medicines Agency had recommended testing for DPD deficiency prior to treatment with these drugs. At that time, DPD deficiency was mentioned in U.S. product labels for these common cancer treatments, indicating that no dose of these therapies has been proven safe in patients with this deficiency, but testing was not recommended by the FDA. DPD is an enzyme that metabolizes fluoropyrimidines. Those with DPD deficiency have a decreased capacity to metabolize these drugs, meaning that it is much easier to overdose. Patients with complete and partial DPD deficiency, also known as poor and intermediate metabolizers, are therefore at greatly increased risks of severe and fatal treatment-related adverse events when treated with these therapeutics.

In the time since, the FDA has serially moved to update product labels for 5-fluorouracil (5-FU) and Xeloda (capecitabine), the two major fluoropyrimidine chemotherapies. In 2022 and 2024 respectively under Project Renewal, the FDA updated the capecitabine and 5-FU product labels to provide additional information on DPD deficiency and recommend that doctors consider testing for DPD deficiency prior to treatment with these drugs. Now, after increasing calls from patient advocates and collaborating with the AACR on a public workshop exploring the scientific basis and regulatory considerations for modifying FDA product labeling to require testing, the FDA updated the label of capecitabine to explicitly recommend testing for DPD deficiency prior to initiating therapy. This update also includes a black box warning, the highest safety-related warning that the FDA gives, and a specific ask of the 2020 Citizen’s Petition.

While the FDA now recommends testing, questions remain about implementation. While patients who are poor metabolizers should not receive any dose of fluoropyrimidines, dosing is less clear for those who are intermediate metabolizers. There are clinical guidelines created by the Clinical Pharmacogenetics Implementation Consortium (CPIC) regarding what dosage to give patients who are intermediate metabolizers, but larger American oncology clinical guideline bodies such as the National Comprehensive Cancer Network (NCCN) and the American Society of Clinical Oncology (ASCO) have not yet adopted either a recommendation for DPD testing or specific dosages for use in intermediate metabolizers. Additionally, insurance does not always cover DPD testing, which is currently evaluated through an off-site laboratory developed test (LDT), as the FDA has not yet approved a diagnostic test for DPD deficiency. Finally, it is not clear if or when the FDA will update the label of 5-FU to reflect the changes now present in the capecitabine label. While these uncertainties remain, this is a landmark achievement for patient safety and for the patient advocates who have long advocated for a DPD testing requirement.

Senate HELP Committee Explores the Future of Biotechnology and U.S. Innovation

-Carly McCallie

On October 29, the Senate Committee on Health, Education, Labor, and Pensions (HELP) held a hearing titled “The Future of Biotech: Maintaining U.S. Competitiveness and Delivering Lifesaving Cures to Patients”. Committee Chair Bill Cassidy, MD (R-LA), opened the discussion by celebrating the transformative impact of American innovation, citing vaccines, cell and gene therapies, and medical devices as examples of how biotechnology continues to save lives and strengthen the economy. He urged Congress to “pick up our game” to maintain global leadership by modernizing regulatory frameworks and addressing competition from countries such as China.

Ranking Member Bernie Sanders (I-VT) acknowledged biotechnology’s role in advancing treatment and cures but warned that progress must not come at the expense of affordability and equitable access. He pointed to escalating drug prices and consolidation within the pharmaceutical sector as threats to patients and to the long-term sustainability of the U.S. health system.

Witnesses included:

They underscored the promise and fragility of the U.S. biotechnology ecosystem, citing the need for stable research funding, efficient regulatory processes, and clear policies to support domestic manufacturing and innovation.

Several senators from both parties emphasized the economic and national security dimensions of biotechnology. Senator Andy Kim (D-NJ) questioned whether the United States is acting with sufficient urgency to remain competitive, while Senator Mike Braun (R-IN) and Senator Lisa Blunt Rochester (D-DE) highlighted the need for a coordinated national strategy to strengthen biomanufacturing and supply chains. Witnesses described the growing challenge of conducting research and production in the United States as costs rise and international rivals expand capacity.

Multiple witnesses and senators expressed concern that proposed reductions in staffing and funding at the National Institutes of Health (NIH), the U.S. Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC) could slow innovation and clinical progress. Ramachandran warned that canceled trials and delayed approvals risk driving talent overseas. Crowley emphasized that federal research investment forms the foundation upon which private-sector innovation depends.

FDA modernization emerged as a central theme throughout the hearing. Witnesses recommended more consistent review timelines, improved communication with sponsors, and greater use of advanced trial designs and biomarker validation to accelerate access to therapies without compromising safety. Crowley also urged Congress to reauthorize the Pediatric Priority Review Voucher program, which incentivizes treatments for rare diseases affecting children, noting its history of bipartisan support and tangible success in bringing new therapies to market.

While members differed on how to balance innovation and affordability, there was clear bipartisan agreement that U.S. competitiveness in biotechnology is a national priority. The discussion reflected growing recognition that American leadership in medical research and manufacturing depends on sustained federal investment, regulatory clarity, and strong collaboration among government, academia, and industry.

As the hearing concluded, lawmakers acknowledged that maintaining this leadership will require both immediate and long-term action. That includes rebuilding the federal research workforce, strengthening regulatory capacity, and ensuring patients can benefit from the next generation of scientific breakthroughs developed in the United States.

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

The Scientist↔Survivor Program® 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 AACR Annual Meeting.

Scientist↔Survivor Program Application

Advocate Partners Pavilion Application

Questions may be directed to [email protected].

The AACR at the San Antonio Breast Cancer Symposium

San Antonio Breast Cancer Symposium® (SABCS) proudly celebrates the vital role patient advocates play in advancing breast cancer research, discovery, and care. Each year, the Symposium welcomes nearly 500 patient advocates representing more than 110 organizations worldwide, whose perspectives and experiences are integral to the planning and success of the program. This year, 24 patient advocates will serve as panelists and speakers in the SABCS scientific program, ensuring the patient voice remains at the forefront of all discussions.

As the world’s largest and most influential breast cancer research meeting, SABCS draws over 10,000 attendees from more than 100 countries. Each year, the AACR partners with UT Health San Antonio as co-sponsors of SABCS to present cutting-edge research on the experimental biology, etiology, prevention, diagnosis, and treatment of breast cancer and premalignant breast disease. The Symposium features late-breaking clinical trial data, multidisciplinary sessions, and robust participation from patient advocates, researchers, and clinicians alike.

Reduced registration rates are available for patient advocates. Visit the SABCS Patient Advocate webpage for more information and registration details.

Alicia Jackson Tapped to Lead ARPA-H

-Matt Gontarchick

Alicia Jackson, PhD, a health IT CEO and former Obama administration official, is the newest director for the Advanced Research Projects Agency for Health (ARPA-H).

Sworn in on October 20, Jackson currently works as CEO of Evernow, a digital health platform she founded that offers subscription-based therapies and support for perimenopause and menopause. Jackson is not new to federal government service, as she served at the Defense Advanced Research Projects Agency (DARPA) from 2010 to 2015, first as a program manager and later as a senior official in the agency’s Biotechnology Office. Her experience also includes time as a U.S. Senate staffer, as well as service with other health IT organizations.

Jackson replaces Jason Roos, who had been serving as acting director of ARPA-H since February 2025. Renee Wegrzyn, the agency’s inaugural director, was dismissed three years into a four-year term shortly after the Trump administration took office in January 2025.

Created in March 2022, ARPA-H provides funding for high-risk, high-reward biomedical research projects with the goal of delivering transformative breakthroughs and cures. Among the projects underway at ARPA-H are the development of an automated platform for producing 3D cancer models, new technologies for tumor removal surgeries, and an at-home cancer screening system that uses synthetic biology.

The Trump administration proposed reducing ARPA-H’s budget from its FY 2025 level of $1.5 billion to $945 million, which the House Appropriations Committee approved in its FY 2026 spending bill on September 9. In contrast, the Senate Appropriations Committee voted on July 31 to keep FY 2026 funding for ARPA-H unchanged from the previous year. As the government shutdown continues, the agency’s final FY 2026 funding situation remains uncertain.

Notice of Upcoming PCORI Funding Announcement

-David Zahavi

The Patient-Centered Outcomes Research Institute (PCORI) intends to issue a PCORI Funding Announcement (PFA) on December 2, seeking to fund well-designed, methodologically robust retrospective observational patient-centered comparative clinical effectiveness research (CER) studies that will produce timely, impactful and patient-centered results to inform healthcare decision making and improve health outcomes. PCORI is particularly interested in submissions related to the Topic Theme of Addressing Cancer. Applications will be funded with a budget of up to $2 million in direct costs for a duration of up to 18 months. Highlights of the research initiative include:

  • Applicants must propose a clear comparative effectiveness question by leveraging well-established data sources and infrastructure, such as PCORnet®, ready for patient-centered CER. 
  • Given the retrospective observational nature of this PFA, applications are expected to compare existing interventions that represent a current decisional dilemma and have robust evidence of efficacy or are currently in widespread use.
  • Clinical interventions (such as medications, diagnostic tests and procedures) and delivery system interventions (such as workforce, technologies and healthcare service delivery designs) are appropriate for these studies.

The purpose of the preannouncement is to provide applicants with additional time to identify collaborators; obtain patient and stakeholder input; secure data access; and develop responsive, high-quality proposals. A town hall for applicants will be held December 10 from 12-1 p.m. ET. Additional details regarding the announcement and funding opportunity are available online.

Oncology Approval Recap

-Brad Davidson, PhD 

Between September 25 and October 23, the U.S. Food and Drug Administration (FDA) granted four approvals for oncology drug products, including three new indications for previously approved drugs and the approval of one novel agent.

  • Belantamab mafodotin-blmf was approved in combination with bortezomib and dexamethasone for adults with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy which include a proteasome inhibitor and an immunomodulatory agent. This is the second approval of this drug, after it previously received accelerated approval as a monotherapy in a similar setting and was subsequently removed from the market after failing a trial to confirm patient benefit. The use of belantamab mafodotin-blmf in combination was evaluated by subsequent trials and was the subject of a recent meeting of the FDA Oncologic Drugs Advisory Committee (ODAC). In this meeting, the committee voted 5-3 and 7-1 against approval for two different combination regimens including the drug. The concerns discussed at the meeting included a potential poor optimization of the drug’s dosage, and the lack of U.S. patients in the trials supporting its marketing applications. This approval covers the combination that received the 5-3 vote against approval, but limits its usage to later stage populations than its registrational trial and the ODAC meeting evaluated. Both combinations are approved in the United Kingdom, Europe, and Japan.
  • Cemiplimab-rwlc was approved for the adjuvant treatment of adults with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation. This application received priority review and was assessed under the Real-Time Oncology Review pilot program.
  • Lurbinectedin was approved in combination with atezolizumab for the maintenance treatment of adult patients with extensive-stage small cell lung cancer whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin, and etoposide. Review was conducted under Project Orbis in collaboration with Australia’s therapeutic Goods Administration, Health Canada, Isreal’s Ministry of Health, and Swissmedic. This therapeutic also received priority review and the orphan drug designation.
  • Imlunestrant was approved for adults with estrogen receptor (ER)-positive, human epidermal growth factor 2 (HER2)-negative, estrogen receptor-1 (ESR1)-mutated advanced or metastatic breast cancer after progression on at least one line of endocrine therapy. This is the first approval for this cancer therapeutic.

FDA Reveals the First Nine Recipients of the Commissioner’s National Priority Voucher (CNPV) Program

-Brad Davidson, PhD

The U.S. Food and Drug Administration (FDA) recently announced the first nine drugs to receive a voucher from its new Commissioner’s National Priority Voucher (CNPV) Program. This program, announced in June, allows a significantly shortened marketing application review process for new therapeutic products, reducing the typical 10-12 month wait time to just 1-2 months. The program is similar to other FDA efforts including the priority review designation and priority review programs for neglected tropical diseases and rare pediatric diseases, which allow for six-month reviews.

Over the months since its announcement, drug sponsors have been able to apply to receive a voucher. Additionally, each drug review division at the FDA was directed to nominate a product that addresses a national health priority. These stated priorities included addressing a U.S. public health crisis, delivering innovative cures for the American people, addressing a large unmet need, onshoring drug development and manufacturing, or increasing affordability.

This first round of CNPV recipients includes two drugs relevant to cancer. Cytisinicline received this voucher for its potential as a treatment for nicotine vaping addiction. It has additionally been submitted for approval as a smoking cessation treatment. The FDA has not approved a therapeutic for smoking cessation since varenicline in 2006 and has never approved a treatment for vaping cessation. RMC-6236 is a pancreatic cancer therapeutic targeting KRAS. This therapeutic addresses a large unmet need, as the 5-year survival rate for pancreatic cancer is reported to be only 13%. While the program does not ensure approval, it may accelerate these much-needed therapeutics. The FDA expects to release a new round of CNPV recipients in the coming months.