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Cancer Policy Monitor: November 10, 2026

2026 Election results and fy27 updates

The Balance of Power Shifts as Midterm Elections Reshape Washington 

The 2026 midterm elections delivered a significant shift in Washington’s political landscape, with Democrats winning control of both the House of Representatives and Senate and setting the stage for divided government during the final two years of President Donald Trump’s administration. 

As of the morning of November 9, Democrats have secured 54 Senate seats, including two held by independents who caucus with them, while Republicans have secured 44. The Alaska and Mississippi races have yet to be called. In the House, Democrats have secured 254 seats, well above the 218 needed for a majority, while Republicans have won 162. Nineteen House races remain undecided. The sizable Democratic majority will give party leadership significantly more flexibility to advance its legislative priorities in the 120th Congress than Republican leaders have enjoyed with their narrow majority in the current Congress. 

For the cancer research community, the new balance of power carries important implications for federal investments in the National Institutes of Health (NIH) and National Cancer Institute (NCI), congressional oversight of federal research funding, and policies governing the nation’s medical research enterprise. Changes in congressional leadership could also influence ongoing negotiations over fiscal year (FY) 2027 appropriations, which face an immediate December 11 deadline. 

A New Balance of Power on Capitol Hill 

When the 120th Congress convenes on January 3, Democrats will assume control of both chambers, bringing significant changes to the leadership of committees responsible for federal research funding and health policy. 

Among the most consequential developments is the defeat of Senator Susan Collins (R-ME), the current chair of the Senate Appropriations Committee and a longtime champion of NIH funding. Her departure will create a major leadership transition, with Senator Patty Murray (D-WA) expected to become chair and Senator Lisa Murkowski (R-AK) next in line by seniority to serve as the committee’s top Republican. Senator Jerry Moran (R-KS) has also expressed interest in the position. 

Murkowski has been a strong advocate for Congress’s constitutional spending authority and has raised concerns about efforts to expand political control over federal grants. Her potential leadership role could therefore carry particular significance as lawmakers continue debating federal research funding and congressional oversight of the administration’s grantmaking policies. 

In the House, Representative Rosa DeLauro (D-CT), the current ranking member and a longtime champion of medical research, is expected to become chair of the House Appropriations Committee. Representative Tom Cole (R-OK), who currently chairs the committee and has also been a strong supporter of NIH funding, is positioned to become its top Republican. Their longstanding support for medical research could provide important continuity as Congress navigates the FY2027 appropriations process. 

Beyond appropriations, the elections will also bring significant leadership changes to the committees responsible for federal health policy. In the Senate, Senator Bernie Sanders (I-VT), who caucuses with Democrats, is expected to return as chair of the Health, Education, Labor, and Pensions (HELP) Committee. Republican leadership remains unsettled following the primary defeat of current Chair Bill Cassidy (R-LA). 

Under Senate Republican rules, members cannot simultaneously serve as chair or ranking member of more than one full committee, complicating the selection of Cassidy’s successor. Senator Rand Paul (R-KY) is the most senior returning Republican on HELP, but he currently chairs the Homeland Security and Governmental Affairs Committee. Senator Murkowski is also among the potential successors, while Senator Josh Hawley (R-MO) could emerge as a contender depending on the leadership decisions of more senior members. 

In the House, Representative Frank Pallone (D-NJ) is expected to become chair of the Energy and Commerce Committee, while current Chair Brett Guthrie (R-KY) is positioned to become its top Republican. Together, the HELP and Energy and Commerce committees will play important roles in shaping federal health policy, medical research legislation, and congressional oversight in the 120th Congress. 

Despite these leadership changes, longstanding bipartisan support for NIH and NCI remains an important foundation for federal cancer research policy. That shared commitment will be especially important as lawmakers navigate competing spending priorities and disagreements over the appropriate balance of authority between Congress and the executive branch. 

FY2027 Funding Negotiations and Stopping OMB Proposal 

The shift in congressional control has introduced new political considerations into efforts to complete FY2027 appropriations before the current continuing resolution (CR) expires on December 11. Although congressional appropriators had expressed optimism about completing spending legislation during the lame-duck session, the election results have raised questions about whether major funding decisions will be finalized this year or deferred until the 120th Congress convenes in January. 

Lawmakers must navigate disagreements over defense and non-defense spending levels, congressional spending authority, and other legislative priorities. One possible outcome is a package combining several completed appropriations bills with another short-term funding extension for more contentious measures, including the Labor, Health and Human Services, Education, and Related Agencies (Labor-HHS) appropriations bill, which funds NIH and NCI. 

For researchers and institutions dependent on federal support, another funding extension would prolong uncertainty and complicate research planning. NIH has already advised that institutes and centers may issue noncompeting research awards below previously indicated levels while operating under the current CR, with potential upward adjustments once final FY2027 appropriations are enacted. 

The AACR and the broader medical research advocacy community have urged Congress to provide at least $51.303 billion for NIH and $7.999 billion for NCI in FY2027. These investments would strengthen the nation’s medical research enterprise, support scientific discovery, and accelerate progress against cancer. 

The December 11 deadline also carries significant implications for federal grantmaking policies. In May, the White House Office of Management and Budget (OMB) proposed sweeping revisions to the federal Uniform Guidance that would give senior political appointees greater authority over grantmaking decisions, expand agencies’ ability to terminate awards, and weaken the role of scientific merit review. The AACR strongly opposed the proposal, submitting detailed formal comments warning that the changes could introduce political considerations into research funding decisions, disrupt ongoing scientific projects, and jeopardize progress for patients. 

As part of the current CR, Congress temporarily prohibited OMB from finalizing or implementing the proposed changes through December 11. The provision reflected bipartisan concerns about the proposal, including opposition from Senators Susan Collins (R-ME) and Patty Murray (D-WA), who helped negotiate the funding agreement. With those protections set to expire alongside the CR, lawmakers must determine whether to extend them as part of the next funding agreement or pursue a more permanent legislative solution. 

The approaching deadline has also prompted renewed advocacy across the research and nonprofit sectors. On November 10, the National Council of Nonprofits is organizing a National Day of Action to urge Congress to permanently block OMB’s proposed changes to federal grantmaking. AACR is encouraging members of the cancer research community to participate by contacting their members of Congress and urging them to protect scientific merit review, prevent political interference in federal research funding decisions, and support robust FY2027 investments in NIH and NCI. These decisions will have lasting implications for the stability of the nation’s medical research enterprise and its ability to deliver new discoveries and treatments to patients. Members can make their voices heard through the AACR Legislative Action Center. 

AACR Opposes NIH Proposal to Change Reporting of Peer Review Outcomes 

–David Zahavi, PhD

The American Association for Cancer Research (AACR) submitted comments on October 13 opposing the National Institutes of Health’s (NIH) proposed changes to how peer review outcomes are reported to grant applicants and institutions. Under the proposal, numerical scores and percentile rankings would be replaced with three broad categories: “Most Competitive” for applications in the top 25th percentile, “Competitive” for applications between the 26th and 50th percentiles, and “Not Discussed” for applications in the bottom 50th percentile. The numerical scores and percentile rankings would no longer be available to principal investigators, applicant institutions, NIH program staff, Institute and Center leadership, or Advisory Councils. 

In its response to NIH’s Request for Information, AACR raised concerns that eliminating the reporting of final overall impact scores and percentile rankings would significantly reduce transparency, accountability, and trust in the NIH grantmaking process. AACR emphasized that overall impact scores and percentile rankings are important tools for evaluating the effectiveness, consistency, and fairness of NIH peer review. Investigators also rely on scores and percentiles to evaluate the competitiveness of applications, make decisions about resubmissions, and refine proposals in response to reviewer feedback. AACR recommended that NIH withdraw the proposal and retain reporting of final overall impact scores and percentile rankings.

AACR Warns Proposed Census Changes Could Undermine Efforts to Address Cancer Health Disparities 

–David Zahavi, PhD

The U.S. Census Bureau has proposed changes to the 2030 decennial census that could have significant implications for public health surveillance and cancer disparities research. Published on September 10, the proposed rule, “Decennial Census of the Population of Americans; Proposed Residence Criteria and Proposed Regulations for Demographic Questions”, would revise criteria for determining who is included in the population count used for congressional apportionment and prohibit questions about race, ethnicity, and sexual orientation on the decennial census questionnaire. Although the Census Bureau claims it can continue to collect these data through the American Community Survey and other methods, the proposed changes would affect the completeness, consistency, and comparability of population data used in research and public health planning. 

Accurate population level data are essential to understanding the burden of cancer across racial and ethnic groups. Federal cancer surveillance programs rely on Census Bureau population estimates to calculate cancer incidence and mortality rates, identify disparities, and monitor progress in cancer prevention and control. For example, the Centers for Disease Control and Prevention uses population estimates stratified by race, ethnicity, age, and sex to calculate rates of cancer incidence and death, while the National Cancer Institute incorporates Census Bureau estimates into population data used by its Surveillance, Epidemiology, and End Results (SEER) Program. Changes that compromise the accuracy or consistency of these estimates could make it more difficult to identify populations experiencing disproportionate cancer burdens and evaluate trends over time. Disease rates are calculated using population estimates as denominators, therefore changes in who is counted and where they are counted could produce apparent changes in disease rates even if the actual number of cases or deaths remains unchanged.  

The potential loss of race and ethnicity data from the decennial census could further complicate the work of cancer disparities researchers, who depend on reliable, disaggregated data to identify differences in cancer incidence, mortality, screening, stage at diagnosis, and survivorship among minority populations. Preserving high-quality demographic information is essential to identifying populations facing disproportionate cancer burdens, directing resources to underserved communities, and evaluating whether cancer prevention and treatment initiatives are improving outcomes equitably. 

The Census Bureau initially set an October 13 deadline for public comments but subsequently extended the comment period through November 2, following pressure from both the public and research community. In response to the proposed rule, AACR submitted a formal comment advocating against the proposal that outlined concerns regarding the potential consequences for cancer disparities research and broader public health. AACR emphasized the importance of accurate, complete, and reliable demographic data for understanding differences in cancer burden, guiding evidence-based interventions, and measuring progress toward reducing cancer health disparities. 

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

At the 19th AACR Conference on the Science of Cancer Health Disparities, AACR’s Patient Advocacy Program convened two roundtable discussions that brought together patient advocates, researchers, and community partners to identify actionable strategies for improving equitable access to cancer screening and early detection. Both discussions underscored the importance of translating patient and community perspectives into research priorities, health-system practices, and public policies that address persistent disparities across the cancer continuum. 

Roundtable One: What Can We Do to Advance Equitable Screening and Early Detection? 

The October 19 discussion featured a keynote presentation by Dr. Carmen E. Guerra, Associate Director of Community Outreach and Engagement at the Abramson Cancer Center at the University of Pennsylvania and conference program chair. Dr. Guerra highlighted the persistent disparities in cervical cancer screening and mortality, as well as the potential of HPV self-collection to reduce barriers to screening. She shared findings from the NCI SHIP trial demonstrating 92% agreement between self-collected and clinician-collected samples for high-risk HPV detection using the BD assay. Following the FDA’s April 2026 approval of the first at-home HPV self-collection test, Dr. Guerra discussed the opportunity to bring screening directly into underserved communities through partnerships with faith-based organizations, community health centers, and other trusted local partners. 

Her presentation also illustrated an important policy consideration: scientific advances alone do not guarantee equitable access. Successful implementation requires attention to affordability, insurance coverage, availability of testing, culturally and linguistically appropriate education, and reliable pathways to follow-up care for individuals with positive results. 

Carmen White, who leads U.S. and Global Health Equity at Pfizer, shared examples of industry-community partnerships designed to address barriers to care, including patient financial navigation, health literacy, community-based screening initiatives, and clinical trial education. Her remarks reinforced the importance of listening to community partners, building on existing resources, and developing solutions collaboratively rather than creating programs without community input. 

Roundtable Two: Finding Cancer Earlier-Building Trust and Expanding Access to Early Detection 

On October 20, founder of the Black Cancer Collaborative and patient advocate conference chair Kimberly Richardson moderated an interactive discussion that challenged participants to think beyond identifying barriers and consider the concrete changes they would recommend to cancer center leadership and healthcare systems if given the opportunity to influence institutional priorities and investments. 

Patient advocates identified numerous obstacles to screening and early detection, including transportation, out-of-pocket costs, insurance gaps, limited access to local providers and specialists, inconsistent primary care, inaccessible services, and inadequate follow-up after abnormal screening results. Participants also highlighted the consequences of medical mistrust, symptoms being dismissed, limited awareness of screening recommendations, and unequal access to clinical trials. 

The discussion moved beyond identifying challenges to outlining policy and institutional changes that could address them. Recommendations included: 

· Establish sustained partnerships with community-based organizations, federally qualified health centers, and trusted local leaders to bring screening and education directly into underserved communities. Support community health workers and patient navigators who can help address transportation, insurance, financial, and other barriers to completing care. 

· Ensure that patients have access to appropriate, guideline-concordant screening regardless of where they receive care or their socioeconomic circumstances. Health systems must examine disparities in screening practices and address gaps in follow-up and continuity of care. 

· Include patient advocates and community representatives from the earliest stages of research planning, study design, implementation, and evaluation, not simply when research is ready for dissemination. Participants also encouraged institutions and research funders to establish meaningful expectations for patient engagement, with defined roles, resources, and measurable outcomes. 

· Recognize that meaningful community partnerships require dedicated funding, protected time, workforce development, and institutional commitment. Researchers and early-career scientists need the resources and training to build relationships with communities beyond the walls of academic institutions. 

· Incorporate practical wraparound services, including transportation, parking, lodging, and other support, into clinical trial planning to make participation more accessible and representative of the communities affected by cancer. 

Participants also emphasized the importance of building trust through plain-language communication, culturally responsive education, and consistent engagement with communities long before a cancer diagnosis or research study requires their participation. 

Together, the two roundtables reinforced that reducing cancer disparities requires a coordinated approach that connects scientific innovation with meaningful community engagement and policy change. New screening technologies, including at-home HPV self-collection, offer tremendous promise, but their impact will depend on whether patients can afford, access, understand, and act on the results. 

The conversations also highlighted a shared responsibility among researchers, healthcare institutions, industry, policymakers, and community organizations to invest in the infrastructure and resources needed to address cancer disparities in prevention and early detection. The message from patient advocates is clear. Addressing cancer disparities requires more than scientific progress alone. It demands sustained investment, meaningful partnerships, and accountability to ensure that advances in cancer research reach and benefit all communities. 

AACR is committed to ensuring that patient advocates have meaningful opportunities to contribute to these conversations and help inform the research, policies, and systems that ultimately shape outcomes for people affected by cancer. 

Trump Administration Issues Executive Order Establishing Women’s Health Division at NIH 

–David Zahavi, PhD

On October 19, President Trump signed an executive order directing the National Institutes of Health (NIH) to establish a new Women’s Health Division within 90 days and establishing a White House Women’s Health Task Force. The new Women’s Health ​Division at NIH will not replace the agency’s current Office of Research on Women’s Health (ORWH) ​but will have a broader mandate beyond research and will coordinate with ORWH to expand research on women’s health conditions, strengthen inclusion of women and girls in clinical trials, improve understanding of sex-specific health outcomes, and accelerate the translation of research discoveries into clinical practice. 

The executive order identifies cancer among the conditions for which additional research is needed and directs the new division to advance research across women’s health conditions throughout the lifespan. Its responsibilities will include increasing scientific review of understudied conditions, supporting replication studies, promoting advanced research technologies, strengthening interdisciplinary collaboration, and facilitating the translation of scientific discoveries into clinical and public health practice. 

The new division is meant to build on more than 30 years of work by ORWH, which serves as NIH’s focal point for women’s health research and has supported efforts to improve the representation of women in clinical research and introduce NIH policy that requires investigators to consider sex as a biological variable in applicable research involving humans and vertebrate animals, with the goal of improving the rigor and applicability of biomedical research. For the cancer research community, greater coordination of women’s health research could help advance understanding of how sex influences cancer risk, biology, treatment response, and outcomes and support research on cancers that uniquely or disproportionately affect women.  

The White House Women’s Health Task Force, co-chaired by Health and Human Services Secretary Robert F. Kennedy Jr. and White House Chief of Staff Susie Wiles, will be charged with coordinating women’s health initiatives across federal agencies. The task force, supported by HHS funds, will bring together leaders from agencies including NIH, the Food and Drug Administration, the Centers for Disease Control and Prevention, and the Centers for Medicare & Medicaid Services to advance research, strengthen prevention and early detection, and accelerate the translation of scientific findings into evidence-based clinical care. It may also convene public meetings and solicit input from researchers, clinicians, academic institutions, and other experts to inform policy and regulatory reforms.  

The executive order does not provide a specific new funding appropriation for either the division or task force, however, and states that implementation is subject to the availability of appropriations. Ultimately, the division and task force’s impact on women’s health and cancer research will depend on whether they receive adequate resources and complement existing federal and NIH programs while translating their broader mandate into meaningful advances in research, prevention, and patient care. 

Senator Murray Forms Public Health Working Group  

–Matt Gontarchick

Senator Patty Murray (D-Washington), Vice Chair of the Senate Appropriations Committee, announced the formation of a new working group on October 7, 2026, tasked with developing legislative proposals to strengthen America’s public health system and protect public health agencies from political interference. The working group’s formation follows a tumultuous period beginning in early 2025 that saw sweeping personnel dismissals, policy changes, and the sidelining of scientific and medical expertise across multiple federal health agencies. 

The Public Health for America Working Group will center its work on six organizational principles: improving public trust in science, building guardrails against political interference, focusing public health on prevention, modernizing public health agencies, strengthening systems to address emergencies, and providing equitable access to health information and services. 

Inaugural members of the working group are Dr. Joshua Sharfstein, former Principal Deputy Commissioner of the Food and Drug Administration (FDA); Patty Hayes, RN, MN, Chair of the Washington State Board of Health; Dr. Jeffrey Levi, Professor Emeritus of Health Policy and Management at The George Washington University Milken Institute School of Public Health; Dr. Helen Chu, Professor of Epidemiology and Medicine at the University of Washington Schools of Medicine and Public Health, who served on the Advisory Committee on Immunization Practices at the Centers for Disease Control and Prevention (CDC) until the committee’s entire membership was dismissed in June 2025; and Dr. Vin Gupta, pulmonologist and critical care physician. 

In a press release announcing the working group’s formation, Sen. Murray cited several examples of political interference that have undermined the U.S. public health system. These include the dismissal of thousands of public health experts from the federal government, the promotion of vaccine-skeptical views and policies, and the cancellation of promising research. A New York Times article on the working group additionally noted that Sen. Murray had recently called the CDC director to ask why the agency had not reported several measles deaths in Pennsylvania.  

The Public Health for America Working Group will convene roundtable discussions with clinicians, researchers, and public health experts from various backgrounds and communities to inform nonpartisan policy proposals that Sen. Murray intends to use as the basis for future legislation. According to the senator’s office, the working group’s mission is not simply to restore the nation’s public health system to how it stood before the administration began making sweeping changes in January 2025 – it is to build a public health system that is stronger, more resilient, and structurally protected from political interference, regardless of who holds the White House or controls Congress. 

At an October 14 event at Washington State University formally launching the working group, Sen. Murray suggested limiting the number of political appointees at federal health agencies such as the CDC and providing more stable funding for state and local health departments. She also invited the public to share ideas with her office at [email protected].  

Sen. Murray has long been a champion of medical research and a strong proponent of robust, predictable, and reliable funding for the National Institutes of Health (NIH), including pushing back against the administration’s proposed cuts to the NIH’s base program budget. Most recently, she helped secure language in the current continuing resolution that prohibits the Office of Management and Budget (OMB) from finalizing its proposed federal grants rule through December 11. 

FDA Announces Rare Disease Framework Initiative 

–Brad Davidson, PhD

In mid-October, the U.S. Food and Drug Administration announced their Rare Disease Framework Initiative, which seeks to reimagine the development of therapeutics for rare diseases. Rare disease drug development is challenging due to small patient populations, which leads to issues adequately enrolling randomized or single arm trials and determining the effects of treatments across any further subgroups. This initiative recognizes these difficulties, and plans to work to develop “optimized, fit-for-purpose framework that reflects the realities of rare disease drug development by considering the nuances of each disease, patient needs, product type and the evidence that can be realistically generated in small patient populations.” 

While this new framework does not directly address cancer drug development, new clinically relevant biomarker-defined subsets of common cancers are being identified, and many rare cancer patient populations continue to experience high unmet need. This initiative could have a significant impact on the regulatory processes governing drug development in these diseases. FDA has released a “Request for Information” to solicit feedback from the community on their new framework, with a comment deadline of December 11, 2026.  

Rural Health Transformation Program Supports Cancer Screening and Prevention Initiatives 

–David Zahavi, PhD

The Centers for Medicare & Medicaid Services (CMS) and state officials have announced initial investments under the federal Rural Health Transformation Program (RHTP), including initiatives to expand cancer screening and prevention services in rural communities. The RHTP was established under the 2025 budget reconciliation bill covering tax and spending policy, also known as the “One Big Beautiful Bill Act”. Administered by CMS, the program provides $50 billion over five years to help states strengthen rural health care systems, expand access to services, recruit and retain health care professionals, modernize facilities and technology, and develop sustainable models of care. 

When CMS announced the first RHTP awards on December 29, 2025, it confirmed that all 50 states would receive funding and identified each state’s initial fiscal year 2026 allocation. These initial awards provided funding to state governments to implement their rural health transformation plans, with states subsequently identifying specific projects and committing portions of their allocations to individual initiatives. On October 1, 2026, CMS and Alabama officials announced that nearly $55 million of their funding would be used to support 34 grants to health care providers and institutions across Alabama, including projects focused on expanding mobile and community-based cancer screening, strengthening rural health care workforce pipelines, and improving access to emergency care. On October 9, 2026, Iowa announced that it had fully obligated its $209 million first-year RHTP award to its Healthy Hometowns initiative. The initiative included investments in cancer prevention and screening, mobile health services, workforce development, expanded clinical services, and modernization of health information systems. The announcement highlighted key accomplishments such as the addition of three new rural cancer prevention specialists, expanded screening for uninsured Iowans, radon mitigation educational awards, and 96 telehealth tablets deployed across 65 counties. 

These examples illustrate how the RHTP could help address longstanding barriers to cancer prevention and early detection in rural communities, where residents may face longer travel distances, transportation challenges, provider shortages, and limited access to specialized services. The extent to which these RHTP initiatives reduce rural health disparities will depend on effective implementation, sustained support, and access to follow-up diagnostic services and treatment after screening. Future outcomes research will be important in evaluating whether these investments improved rural access to evidence-based cancer prevention and early detection and meaningfully impacted cancer outcomes.

Oncology Approval Recap 

Between September 25 and October 22, FDA issued approvals that added new indications for six previously approved therapeutics.  

  • Pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph received traditional approval for adult and pediatric patients with unresectable or metastatic tumor mutation burden-high (TMB-H) [≥13 mutations/megabase] solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options. This represents a conversion from accelerated approval and increases the level of TMB-H indicated, as efficacy was not confirmed in patients with TMB between 10 to <13.  
  • Dostarlimab was granted accelerated approval for adults with stage II/III locally advanced rectal cancer that is microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR). Review was conducted under Project Orbis in collaboration with Health Canada (HC), Israel’s Ministry of Health (IMoH), Switzerland’s Swissmedic (SMC), and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA). The application also received the Commissioner’s National Priority Review Voucher pilot program and was granted priority review. Dostarlimab received breakthrough therapy designation. 
  • Nogapendekin alfa inbakicept-pmln was approved with Bacillus Calmette-Guerin (BCG) for adults with BCG-unresponsive non-muscle invasive bladder cancer. This expands a previous indication, previously only being approved for adults with adults with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary grade tumors.  
  • Atezolizumab was approved in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of patients two years of age and older with Stage III dMMR colon cancer. A subcutaneous formulation of atezolizumab in combination with the same chemotherapies was also approved in this setting, but for patients 12 or older who weigh 40kg or more. Review was conducted under Project Orbis in collaboration with the TGA, HC, ImoH, and Swissmedic.  
  • Tucatinib was approved in combination with trastuzumab and pertuzumab for the maintenance treatment of adults with unresectable locally advanced or metastatic HER2-positive breast cancer following induction treatment.  
  • Pirtobrutinib was approved for adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma with no known 17p deletion. Pirtobrutinib received orphan drug designation.