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Cancer Policy Monitor: January 13, 2026

Congress Returns with a Funding Deadline Fast Approaching

-Carly McCallie

As Congress returns from the holiday recess, lawmakers face a narrowing window to complete work on fiscal year 2026 appropriations and avoid another round of funding instability. The current continuing resolution is set to expire on January 30, placing renewed focus on whether Congress can advance full-year appropriations bills or once again rely on a short-term funding extension to keep the government operating. 

In late December, House and Senate appropriators reached an important milestone. House Appropriations Committee Chair Tom Cole (R-OK) and Senate Appropriations Committee Chair Susan Collins (R-ME) announced a bicameral agreement on topline funding allocations for the nine remaining fiscal year 2026 appropriations bills. According to Chairman Cole, the agreement keeps overall spending below the levels projected under the November continuing resolution. While the topline numbers have not been made public, the agreement cleared a major procedural hurdle and allowed negotiations on individual bills to resume. 

Significant challenges remain, particularly in the Senate. On December 18, the Senate failed to advance a procedural vote to consider a five-bill minibus that includes the fiscal year 2026 Labor, Health and Human Services (HHS), and Education appropriations bill, which funds the National Institutes of Health and other key health and research programs. Notably, the Labor HHS Education bill was approved by the Senate Appropriations Committee in July, underscoring that the current delay reflects political dynamics rather than unresolved policy work. 

As the January 30 deadline approaches, congressional leaders in both chambers have signaled a desire to complete full-year appropriations. Senate Majority Leader John Thune (R-SD) and Senate Minority Leader Chuck Schumer (D-NY) have expressed a shared goal of funding the government ahead of the deadline. Speaker Mike Johnson (R-LA) has similarly told House Republicans that leadership aims to finish the remaining appropriations bills rather than rely on another short-term funding patch, though skepticism persists among rank-and-file members about whether that timeline is realistic. 

One of the central fault lines shaping the negotiations is pressure from fiscal conservatives to constrain overall spending. House Freedom Caucus Chair Andy Harris (R-MD) and other hard-line Republicans, including Chip Roy (R-TX), have called for holding fiscal year 2026 spending at or below fiscal year 2025 enacted levels. While framed as fiscal restraint, such an approach would effectively reduce funding in real terms and could have significant consequences for nondefense discretionary programs, including biomedical research. 

House Democratic appropriators have signaled readiness to engage. Representative Rosa DeLauro (D-CT), the top Democrat on the House Appropriations Committee, has stated that Democrats are prepared to move forward, though negotiations on policy details have been slowed by the time required to reach agreement on topline allocations. 

For the biomedical research community, the stakes of the January negotiations are high. Continued delays and uncertainty undermine long-term planning at NIH, disrupt research timelines, and compound challenges already facing the scientific workforce. The Labor HHS Education bill remains a critical vehicle for sustaining momentum in cancer research, supporting early-career investigators, and ensuring patient access to clinical trials and emerging therapies. 

As lawmakers return to Washington, D.C., the coming weeks will determine whether Congress can translate topline agreements into enacted appropriations bills or whether additional stopgap measures will again postpone resolution. AACR will continue to monitor developments closely and assess the implications for NIH funding and the broader cancer research enterprise as the appropriations process enters this critical phase. 

AACR Held a Congressional Briefing to Release the AACR Pediatric Cancer Progress Report 2025

-David Zahavi, PhD

On December 4, 2025, the American Association for Cancer Research (AACR) held a congressional briefing in the Kennedy Caucus Room of the Russell Senate Office Building on Capitol Hill to release the AACR Pediatric Cancer Progress Report 2025. This inaugural edition of the report provided 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 investment in research and support programs. 

The congressional briefing convened acclaimed researchers, pediatric cancer survivors and their families, members of the patient advocacy community, government representatives, and policymakers to highlight scientific advances, share inspiring patient stories, and discuss opportunities to accelerate progress against pediatric cancer. The event drew hundreds of attendees in person and online and featured remarks from AACR Chief Executive Officer Margaret Foti, PhD, MD (hc); Congressman Michael McCaul (R-TX); 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. The panel of speakers connected robust Federal investment to tangible improvements in outcomes for children with cancer and highlighted opportunities to accelerate progress against pediatric cancer.

A recording of the briefing is available on YouTube and the full AACR Pediatric Cancer Progress Report 2025 is available online. 

CDC Advisory Committee on Immunization Practices Begins Reshaping of Childhood Vaccine Schedule

-David Zahavi, PhD

On December 5, 2025, the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted 8-3 to significantly alter the long-standing guidance that all newborns receive a dose of the hepatitis B vaccine within 24 hours of birth. Instead, the universal birth-dose recommendation, established in 1991 and credited with dramatic reductions in pediatric hepatitis B infections, is replaced with a policy of individual-based decision-making for infants born to mothers who test negative for hepatitis B. On December 16, 2025, the Acting Director of the CDC and Deputy Secretary of Health and Human Services Jim O’Neill approved the change and the CDC updated the child immunization schedule and clinical guidance related to hepatitis B vaccines to reflect and implement the new ACIP recommendation.

Under the new policy, infants born to parents who test negative for hepatitis B are not automatically recommended to receive the vaccine at birth. Instead, physicians and parents are advised to engage in shared clinical decision-making to determine whether and when to initiate the hepatitis B vaccine series, with the earliest suggested start being two months of age for those who forgo the birth dose. Infants born to mothers who are hepatitis B positive or whose status is unknown will continue to be recommended for immediate vaccination at birth.

The universal hepatitis B vaccine dose at birth has been a cornerstone of U.S. immunization policy and a public health success. Hepatitis B virus infection can lead to chronic liver disease, cirrhosis, and liver cancer, particularly when infection occurs at birth or in early childhood. Since the inception of universal hepatitis B vaccine dosing at birth, childhood hepatitis B incidence in the U.S. has declined by 99%, and vaccination reduces a person’s risk of liver cancer by 84% and death from liver disease by 70%. Without universal vaccination, as many as 9 in 10 infants infected with hepatitis B in their first year of life will develop chronic infections that can lead to liver failure, cancer, and death.

The new recommendations reflect ongoing efforts by Department of Health and Human Services Secretary Kennedy to reshape U.S. vaccine policy. The new policy was met with strong objections from many health professional organizations, public health officials, and policymakers. They warn that shared clinical decision-making may be interpreted by providers and parents as a signal that the vaccine is controversial or unnecessary, increasing the risk of delayed or missed vaccinations. The American Academy of Pediatrics condemned the change and reiterated its support for universal hepatitis B vaccine birth dosing. Likewise, Senator Bill Cassidy, chair of the Senate Health, Education, Labor, and Pensions Committee, released a statement supporting universal hepatitis B vaccines at birth and urging the CDC not to implement the new recommendation.

The shift toward individual-based decision-making for the hepatitis B vaccine birth dose will have significant ramifications for cancer prevention policy. Researchers must now monitor for outcomes related to the policy change to inform future strategies for hepatitis B control. Moving forward, the Department of Health and Human Services may continue to alter recommendations for other proven, safe, and effective childhood vaccines which will have dire consequences for broader disease prevention and public confidence in vaccine policy.

Angelo de Claro Named Acting Director of FDA Oncology Center of Excellence

-Brad Davidson, PhD

Angelo de Claro, MD, is now the acting director of the FDA Oncology Center of Excellence (OCE). He has been at the FDA since 2010, serving initially as a medical officer in the Division of Hematology Products. Since 2019, he has been the director of the Division of Hematologic Malignancies I, which oversees the regulation of therapeutic products for acute leukemias and myelodysplastic syndromes, chronic myeloid leukemia and other myeloid neoplasms, and supportive care for stem cell transplantation and immune effector cell therapies. He has also led Project Orbis, a collaborative framework for concurrent submission and review of oncology drugs among international regulatory partners, as part of his role as associate director for global clinical sciences in OCE. de Claro had been the deputy center director of OCE since March 2024.

de Claro steps into this role in the wake of the departure of Richard Pazdur, MD, the 26-year agency veteran who founded OCE and had directed it ever since. Pazdur left the agency in December shortly after being elevated to the director of the Center for Drug Evaluation and Research (CDER), but it was unclear whether Pazdur would have continued to lead OCE. Oncology experts across academia, industry, and advocacy, including AACR, had largely heralded Pazdur’s selection as CDER director as a boon for both drug development and patients, given his reputation for innovation, rigor, and candor as OCE director. de Claro will now take over a center that has been subject to numerous departures of long-time leaders, as have many FDA other divisions.  

Mikaela Naylon Give Kids A Chance Act Narrowly Misses Senate Passage

-Blake William Rostine

After the U.S. House unanimously passed the Mikaela Naylon Give Kids A Chance Act, a landmark bill which would improve overall access to advanced cancer treatments for pediatric cancer patients, advocates had hoped for quick passage in the Senate, following multiple CR-related delays.

However, Senator Bernie Sanders (I-VT) voted ‘nay’ on its passage. In a subsequent vote, Senator Markwayne Mullin (R-OK), who introduced the bill into the Senate, voted ‘nay’, likely in an attempt to address Senator Sanders’ concerns.

Senator Sanders, who has voiced his support for the bill, asked for community health center provisions and overall healthcare package components to be included as amendments into the bill. Senator Sanders was ultimately not satisfied by Senator Cassidy’s (R-LA) promise to pass these in separate bills.

The bill, which can be read online, will be revisited in 2026.

Trump Administration Establishes Most Favored Nation Deal with Nine Pharmaceutical Companies

-Blake Willliam Rostine

In a move to address rising prescription costs, and to better compete with other high-income nations, nine pharmaceutical companies have reached agreements established by the Trump administration. This follows President Trump’s outreach to 17 companies and what actions they “must take” to moderate costs.

Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Gilead Sciences, GSK, Merck & Co., Novartis, Roche’s Genentech, and Sanofi will work with the administration to achieve most favored nation status. They will join Pfizer, AstraZeneca, Merck KGaA’s EMD Serono, Eli Lilly, and Novo Nordisk. 

These drugmakers have agreed to take measures to reduce U.S. drug prices, to better match pricing structures in other high-income nations. In exchange, these companies will be granted a three-year grace period where their products will not be impacted by proposed pharmaceutical tariffs.

The official press release can be read online.

SABCS 2025 Celebrates Record Patient Advocate Engagement

The San Antonio Breast Cancer Symposium® (SABCS) 2025 marked a landmark year for patient advocates with unprecedented participation that underscored the vital role of the patient voice in shaping the breast cancer research agenda. This year, more than 500 patient advocates took part, representing 202 organizations from 21 countries and 41 U.S. states. Advocates were deeply integrated throughout the Symposium program, contributing as speakers and panelists in 28 sessions spanning scientific, clinical, and policy-relevant topics, and ensuring that the lived experiences of patients were central to discussions on everything from risk assessment and emerging therapies to survivorship and care delivery.

Beyond the formal scientific sessions, SABCS continued its commitment to supporting advocates with dedicated resources and community engagement opportunities that enriched the overall experience. Twenty-eight patient advocacy organizations exhibited in the Advocate Partners Pavilion, and the Patient Advocate Lounge served as a vibrant and welcoming hub for connection, reflection, and peer exchange throughout the meeting.

Patient advocacy organizations and individuals leveraged the Symposium to connect with researchers and clinicians, exchange insights on novel data, and participate in mentoring, training, and networking events. The robust involvement of advocates in SABCS program planning, panel discussions, and exhibition spaces not only amplified patient perspectives but also reinforced SABCS’ collaborative ethos, one in which research and patient advocacy advance in concert toward better outcomes for all people affected by breast cancer.

Apply Now: AACR Annual Meeting 2026 Advocate Partners Pavilion

AACR is now accepting applications for the Advocate Partners Pavilion at the AACR Annual Meeting 2026, taking place April 17-22, in San Diego, California. Only a few exhibit spaces remain.

Selected organizations will receive complimentary exhibit space in a dedicated pavilion, offering a unique opportunity to showcase your mission, resources, and programs to thousands of cancer researchers, clinicians, policymakers, and patient advocates at the world’s premier cancer research meeting. Participation also provides unparalleled opportunities to network with the scientific community and connect with fellow advocacy leaders from across the cancer ecosystem.

Spaces are extremely limited and will be filled on a first-come, first-served basis. Don’t miss this opportunity to elevate your organization’s presence at the AACR Annual Meeting 2026. Apply today to secure one of the remaining spots. Questions may be directed to [email protected].

Advocate Partners Pavilion Application 

Oncology Approval Recap

-Brad Davidson, PhD

Between November 25 and December 29, 2025, the U.S. Food and Drug Administration (FDA) issued seven approvals for oncology drug products.

  • Durvalumab was approved in combination with fluorouracil, leucovorin, oxaliplatin, and docetaxel chemotherapy as a perioperative regimen followed by a single agent durvalumab for adults with resectable gastric or gastroesophageal junction adenocarcinoma. This is the third indication for the use of perioperative durvalumab, and its tenth overall. Review was conducted under Project Orbis in collaboration with the Australian Therapeutic Goods Administration (TGA), the Brazilian Health Regulatory Agency (ANVISA), Health Canada (HC), Isreal’s Ministry of Health (ImoH), and Switzerland’s Swissmedic (SMC). This application was also granted priority review, and durvalumab received breakthrough and orphan drug designations.
  • Pirtobrutinib was granted traditional approval for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor. This constitutes an expansion from its previous accelerated approval, which included adults with CLL/SLL who had received at least two lines of therapy that included a BTK inhibitor and a BCL-2 inhibitor. This is the first full approval for this drug product. Pirtobrutinib received orphan drug designation.  
  • Lisocabtagene maraleucel received approval for adults with relapsed or refractory marginal zone lymphoma who have received at least two prior lines of systemic therapy. This application was granted priority review and this product received orphan drug designation.
  • Niraparib and abiraterone acetate with prednisone was approved for adults with deleterious or suspected deleterious BRCA2-mutated metastatic castration-resistant prostate cancer. This therapeutic was previously approved for BRCA-mutated metastatic castration-resistant prostate cancer. This application was granted priority review.
  • Fam-trastuzumab deruxtecan-nxki was approved in combination with pertuzumab for the first-line treatment of adults with unresectable or metastatic HER2-positive breast cancer. This is the first approval of this product for use in the first-line in any setting. Review was conducted under Project Orbis in collaboration with SMC and used the Real-Time Oncology Review pilot program. This application was granted priority review, and this treatment regimen received breakthrough designation.  
  • Rucaparib was approved for adults with deleterious BRCA-mutated metastatic castration-resistant prostate cancer previously treated with an androgen receptor-directed therapy. This represents a conversion to traditional approval with a slight indication expansion from a previous accelerated approval in this setting, which had also required that patients had already received a taxane-based chemotherapy.
  • Amivantamab and hyaluronidase-lpuj was approved for subcutaneous injection for adult patients across all indications approved for the intravenous formulation of amivantamab, which encompasses four indications across various subtypes of non-small cell lung cancer. Review was conducted under Project Orbis in collaboration with TGA and HC.