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Cancer Policy Monitor: October 14, 2025

Appropriations Progress Overshadowed by Shutdown Fight

-Carly McCallie

As the government shutdown enters its third week, instability across federal agencies continues to grow. What began as a partisan standoff on Capitol Hill has now led to mass layoffs, legal challenges, and partial reversals that have disrupted critical programs and fueled new uncertainty for the nation’s health and research infrastructure. 

On Friday, October 10, the White House confirmed that reductions in force had begun, targeting more than 4,000 federal employees across several departments, including Health and Human Services (HHS), Treasury, and Education. At HHS, between 1,100 and 1,200 staff were initially slated for dismissal, a move unprecedented during a shutdown. Early reports indicated deep cuts to the Centers for Disease Control and Prevention (CDC), including entire offices responsible for global health, immunization, respiratory disease surveillance, and chronic disease prevention. 

Within twenty-four hours, however, the situation shifted again. HHS officials acknowledged that some layoffs were issued in error, with a number of employees now being rehired. Those reportedly reinstated include staff working on the Morbidity and Mortality Weekly Report, the Global Health Center, the Epidemic Intelligence Service, and the Laboratory Leadership Service, all programs central to disease surveillance, outbreak response, and laboratory safety. According to internal sources, a coding error in job classifications triggered dozens of wrongful termination notices. 

The confusion has only deepened the sense of chaos within the department, which has faced months of turnover and controversy. The firings came less than a month after the ouster of CDC Director Susan Monarez, who testified that she was removed after refusing to approve political changes to the childhood vaccine schedule. In recent months, the CDC has also endured a workplace shooting at its Atlanta headquarters and multiple earlier rounds of staff reductions, leaving many offices with limited leadership and institutional continuity. 

Meanwhile, unions representing federal workers, including the American Federation of Government Employees and the AFL-CIO, have filed lawsuits challenging the legality of carrying out reductions in force during a shutdown. Congressional concern is growing across party lines. Senate Appropriations Chair Susan Collins (R-ME) warned that “arbitrary layoffs” would undermine essential public health and research functions, while other Republicans, including Representatives Kevin Kiley (R-CA) and Marjorie Taylor Greene (R-GA), have publicly called on Speaker Mike Johnson to reconvene the House and resume legislative work. 

“The Speaker shouldn’t even think about canceling session for a third straight week,” Kiley wrote, adding that the House should be in Washington “working in every possible way to end the shutdown and to pass actual appropriations bills.” Greene echoed that sentiment, telling CNN, “I’m not putting the blame on the president. I’m putting the blame on the Speaker and Leader Thune. This should not be happening.” 

The Senate is scheduled to reconvene on Tuesday, October 14, for another vote on a short-term spending bill. House Democrats have announced they will return to Washington this week, while the House Republican majority has not scheduled votes. The House has been out of session since September 19, leaving appropriations work, including final action on the fiscal year (FY) 2026 Labor, Health and Human Services, and Education bill, at a standstill. 

These recent developments have overshadowed what had been one of the few areas of bipartisan progress this year. 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 the administration’s proposed 40% cut to the National Institutes of Health (NIH) and reaffirming congressional support for biomedical research. The measure included a $400 million increase for the NIH overall, with $150 million of that directed to the National Cancer Institute (NCI). It also incorporated an amendment offered by Senator Tammy Baldwin (D-WI) to block any further expansion of the administration’s forward-funding policy unless the NIH first preserves its FY 2024 grant volume. The provision drew bipartisan support, including from Senator Collins, who emphasized the importance of maintaining a stable and transparent grantmaking process. 

The House Appropriations Subcommittee on Labor, Health and Human Services, and Education approved its companion measure in early September, providing a smaller $99 million increase for the NIH and maintaining flat funding for the NCI. The House bill, however, also proposed to cap indirect costs at 30% for certain institutions. A move that research universities and scientific organizations have warned would severely restrict their ability to conduct federally funded studies. 

Together, the Senate and House actions represented a meaningful bipartisan rejection of the administration’s proposed cuts and a commitment to protecting the research infrastructure that drives innovation and medical progress. But that progress now hangs in the balance as the shutdown halts appropriations negotiations and undermines the very agencies these bills were meant to strengthen. 

At the close of FY 2025, the NIH successfully obligated nearly all of its $48 billion budget, a relief after months of disruption, but the agency did so by front-loading grant funding and awarding full multi-year budgets up front. That approach reduced the number of new awards by roughly 3,000 compared with the previous year. The NCI payline, which determines which peer-reviewed projects are funded, fell to the 4th percentile, the lowest in its history, leaving many top-ranked cancer proposals unfunded and threatening the next generation of investigators. 

Now, as FY 2026 begins under a shutdown, even that progress is fragile. Peer-review panels remain canceled, new awards cannot be processed, and most NIH intramural research has stopped. The NIH Clinical Center continues treating patients already enrolled in NCI-sponsored trials, but new trial enrollments are largely paused except in emergencies. Across the biomedical research ecosystem, laboratories, cancer centers, and universities face growing financial strain and uncertainty. 

In Congress, frustration is mounting on both sides of the aisle. Some Republicans have warned that remaining away from Washington could appear “absent without leave” during a national crisis. Others have urged leadership to strike a bipartisan agreement to reopen the government. Yet as President Trump prepares to travel overseas and neither chamber signals an immediate breakthrough, the standoff shows little sign of resolution. 

Shutdowns do not save money or advance progress. They waste resources, derail discovery, and erode confidence in the nation’s commitment to science. The bipartisan cooperation that defined this summer’s appropriations work remains the clearest path forward. Whether Congress can reclaim that spirit will determine not only the stability of the NIH and NCI but also the pace of lifesaving progress for patients who cannot afford to wait. 

Anthony G. Letai Named Director of the National Cancer Institute

-Carly McCallie

Anthony G. Letai, MD, PhD, was named the 18th director of the National Cancer Institute (NCI) on Monday, September 29, following a White House announcement. A physician-scientist at Dana-Farber Cancer Institute and Harvard Medical School, Letai is internationally recognized for his pioneering research on apoptosis, cancer cell death, and functional precision oncology. His work contributed to the development of venetoclax, a BCL-2 inhibitor now widely used to treat chronic lymphocytic leukemia and acute myeloid leukemia, and has spurred more than 100 clinical trials testing similar approaches across multiple cancer types.

Letai succeeds W. Kimryn Rathmell, MD, PhD, who resigned in January 2025. For the past nine months, NCI Principal Deputy Director Douglas R. Lowy, MD, has led the institute in an acting capacity. The NCI directorship is a presidential appointment within the Department of Health and Human Services but does not require Senate confirmation.

The American Association for Cancer Research (AACR) welcomed the appointment. “As a top-tier physician-scientist, Dr. Letai brings impressive qualifications to this extremely important position,” said Margaret Foti, PhD, MD (hc), chief executive officer of the AACR. “His appointment as NCI Director is a very promising development after months of uncertainty. Dr. Letai’s enthusiasm for innovative scientific methods and ideas, his appreciation for the value and importance of basic research in making progress for patients, and his commitment to fostering collaboration ensure that NCI will continue to lead the way in its efforts to improve health, prevent cancer, and reduce deaths from this devastating disease. The AACR looks forward to working closely with Dr. Letai and his colleagues at NCI to build upon the remarkable progress that has been made against cancer in recent years.”

The AACR also emphasized that while it has expressed deep concern over recent administration actions affecting the NIH and NCI, Letai’s appointment, combined with bipartisan efforts in Congress to prioritize NIH and NCI funding in FY2026, is a source of renewed optimism about sustaining progress against cancer.

Leaders across the cancer research community praised the choice. “Dr. Letai is an outstanding clinician-scientist who understands the critical role of NCI in bringing about a world free of suffering due to cancer,” said Monica Bertagnolli, MD, former NIH director and incoming president of the National Academy of Medicine, in comments to The Cancer Letter. Former NCI director Norman E. Sharpless, MD, told The Cancer Letter that Letai is “an inspired choice by the Trump administration to direct this complex agency.”

Letai joined the Dana-Farber faculty in 2004 after postdoctoral training in the laboratory of the late Dr. Stanley Korsmeyer, MD, whose groundbreaking work on BCL-2 proteins shaped modern understanding of apoptosis. Building on that foundation, Letai demonstrated how inhibiting BCL-2 could selectively trigger cancer cell death, a discovery that directly informed the development of venetoclax.

His laboratory also pioneered BH3 profiling, an assay that measures a tumor cell’s proximity to apoptosis and is being tested as a predictive biomarker for clinical use. Letai also serves as president of the Society for Functional Precision Medicine, which promotes approaches that use living tumor samples to screen drugs and identify therapies likely to benefit individual patients.

Letai begins his tenure at a pivotal moment, with the NCI confronting political and budgetary pressures. His leadership will be critical in providing stability and sustaining momentum in the nation’s cancer research enterprise.

Trump’s AI Push in Pediatric Cancer Research Comes Against Backdrop of Proposed Cuts

-Carly McCallie

In late September, the White House issued an executive order titled “Unlocking Cures for Pediatric Cancer with Artificial Intelligence,” directing federal agencies to harness artificial intelligence to accelerate discovery and improve outcomes for children with cancer. The order doubles funding for the Childhood Cancer Data Initiative (CCDI) from $50 million to $100 million and instructs the National Institutes of Health (NIH), Food and Drug Administration (FDA), and Department of Health and Human Services (HHS) to expand data sharing, interoperability, and predictive analytics to speed the identification of new treatments. 

The initiative has drawn praise from many in the pediatric cancer community, who hope the expanded use of AI will enhance researchers’ ability to detect patterns, match patients to clinical trials, and identify biomarkers that could guide more effective therapies. The White House described AI as a “force multiplier” that could enable scientists to analyze vast genomic and clinical datasets to uncover therapeutic targets and personalize treatment for rare childhood cancers. 

Yet the announcement arrives during a precarious period for the nation’s biomedical research enterprise. The Trump administration’s FY 2026 budget proposal includes steep reductions to the NIH and NCI, raising concerns about the sustainability of the research infrastructure that enables such advances. Although the executive order pledges to strengthen coordination and innovation, the proposed funding cuts have left scientists questioning how these ambitious goals can be achieved amid tighter budgets and ongoing administrative uncertainty. 

Pediatric cancer researchers have expressed cautious optimism that AI could drive meaningful progress, particularly in rare and hard-to-treat cancers such as diffuse intrinsic pontine glioma (DIPG), a devastating childhood brain tumor. These cancers often lack sufficient data for traditional research methods, and families affected by them have voiced frustration that promising clinical trials have been delayed or defunded. Funding reductions risk slowing the very progress the administration now promises to accelerate. 

The executive order builds on efforts launched under the Childhood Cancer Data Initiative (CCDI), established in 2019 to improve access to and integration of pediatric cancer data. The new directive instructs agencies to enhance CCDI’s databases for greater interoperability and to strengthen partnerships with academic institutions and the private sector to ensure that AI models are trained on diverse, high-quality datasets. It also calls for the creation of a Pediatric AI Council within HHS to coordinate implementation and provide annual progress updates. 

Researchers and advocates have welcomed the focus on innovation but cautioned that artificial intelligence is no substitute for stable, sustained funding. AI models depend on large, well-curated data and robust validation. Without long-term investment in the research infrastructure that supports pediatric trials, data collection, and analysis, experts warn that the potential benefits of AI will remain largely theoretical. 

The tension between technological ambition and fiscal restraint underscores a broader challenge: translating high-level directives into tangible progress for patients. Even the most advanced AI systems cannot replace the need for skilled scientists, functioning agencies, and consistent support for early-stage research. As one investigator noted, “AI can help us find answers faster, but only if we still have the resources to ask the right questions.” 

The executive order’s vision of rapid innovation is compelling, especially for families who have waited too long for new treatments. But its success will depend on whether Congress sustains the funding and infrastructure necessary to turn data into discovery. Without that commitment, the initiative risks becoming symbolic, a hopeful gesture in a year defined by uncertainty for American science. 
 
Learn more online.

2025 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 17-18 for the 13th 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 historic Kennedy Caucus Room on Capitol Hill on September 17, featuring remarks from AACR CEO Margaret Foti, PhD, MD (hc); AACR President Lillian Siu, MD, PhD; AACR Chief Policy Officer Jon Retzlaff, MBA, MPA; Gordon Tomaselli, MD, past president, American Heart Association; Senator Tammy Baldwin (D-Wisconsin); Katie Couric, journalist and co-founder, Stand Up To Cancer; Erika Sward, chief advocacy officer, UsAgainstAlzheimer’s; Nicole Kleinstreuer, PhD, acting NIH deputy director for Program Coordination, Planning, and Strategic Initiatives; and Reed Jobs, founder, Yosemite.

On September 19, over 430 advocates representing 39 states took part in more than 250 meetings with their members of Congress and staff. Participants advocated for Congress to make medical research a national priority by allocating the highest possible increase to the NIH budget in FY 2026. Advocates also urged lawmakers and their staff to complete work on FY 2026 appropriations bills as quickly as possible to avoid the delays and disruptions caused by continuing resolutions and a potential government shutdown.

Advocates and partner organizations also participated in a National Day of Action on September 18, 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 the NIH to improve health, spur progress, inspire hope, and save more lives. See the list of the Rally partner organizations.

AACR Releases 15th Cancer Progress Report

-Blake Rostine

On September 17, 2025, the American Association for Cancer Research (AACR) released the 15th edition of its Cancer Progress Report, a landmark publication documenting the progress of cancer science and the critical role of federal investment in driving lifesaving discoveries.

The report highlights extraordinary advances over the past year, including the U.S. Food and Drug Administration’s approval of 20 new cancer drugs between July 2024 and June 2025. It also underscores the impact of decades of federally funded research, which has helped reduce the overall U.S. cancer death rate by 34% since 1991, averting more than 4.5 million deaths. Yet the report warns of ongoing challenges, such as the rise of early-onset cancers and the uncertainty created by recent instability at the National Institutes of Health (NIH).

The report featured inspiring stories from patient advocates, as well as Congressional features from Senator Katie Britt (R-AL), Senator Tammy Duckworth (D-IL), and Representative Mike Kelly (R-PA), who shared their dedication to advancing cancer research and reaffirmed their commitment to protecting the NIH and the National Cancer Institute. Patient advocates were honored at a private dinner prior to the event, in which AACR CEO Margaret Foti, PhD, MD (hc), and AACR President Lillian Siu, MD, PhD, were able to meet the advocates and celebrate their contributions.

The release of the report at the National Press Club in Washington, D.C., drew hundreds of attendees in person and online, who were able to hear about the advances that have been made in the fight against cancer.

The 15th edition of the Cancer Progress Report can be read online.

Dr. Jon Lorsch Named as NIH Deputy Director for Extramural Research

-David Zahavi, PhD

On September 18, 2025, National Institutes of Health (NIH) Director Jay Bhattacharya, MD, PhD, announced the appointment of Jon Lorsch, PhD, as the agency’s deputy director for extramural research (OER). Lorsch had been serving as acting OER deputy director since April, taking over for Michael Lauer, MD, who retired from federal service in mid-February after having served in the role since October 2015. To lead OER, Lorsch will be stepping down as director of the NIH’s National Institute of General Medical Sciences (NIGMS), a position he has held since August 2013.

As deputy director of OER, Lorsch will serve as the principal scientific leader and advisor to the NIH director on all matters relating to the NIH extramural research program and administration. This includes overseeing the NIH’s complex grant enterprise that successfully administers and awards nearly 60,000 grants at more than 2,500 institutions, supporting the work of more than 300,000 researchers across the United States. At a time of significant NIH upheaval, Lorsch will now oversee policies governing the review and management of all NIH grants, contracts, cooperative agreements, and other award mechanisms. 

NIH Outlines New System for International Collaborations

-David Zahavi, PhD

Scientific and medical research is a global enterprise that often requires collaboration with foreign organizations and individuals that can provide specific resources or expertise. In the past, National Institutes of Health (NIH) funded grants could use subawards to fund international collaborators for studying conditions like childhood cancer, rare genetic disorders, or illnesses such as malaria and tuberculosis that are found more often outside the United States. Under this system, a primary U.S. institution would receive a grant and then issue a subaward to a foreign partner to perform a portion of the project. The primary grant recipient was responsible for overseeing the foreign component and reporting on the entire project’s progress. In the view of the NIH’s new leadership, foreign subawards lacked sufficient transparency, oversight, and accountability. Citing these concerns, the NIH announced on May 1 it will no longer issue new or renewed grants with subawards to foreign entities and it also ended the prior approval process for adding foreign components to ongoing projects. The notice indicated the NIH planned to implement a new award structure for foreign components by September 30, 2025.

NIH Notice NOT‑OD‑25‑155, released September 12, 2025, outlines a new application and award structure for NIH-supported research involving foreign components. Moving forward, prospective NIH applications that include one or more foreign components must respond to a Notice of Funding Opportunity (NOFO) supporting the new PF5 Activity Code for grants, new UF5 Activity Code for cooperative agreements, or other activity codes that support the International Project component type. Only U.S. institutions may be primary grant recipients, and each foreign collaborator must be represented by a distinct International Project component within the application. Reviewers will evaluate both the overall scientific plan and each component (including the foreign components) using the standard NIH scoring criteria, with special attention to whether the proposed foreign partnerships bring unique value not readily attainable in the U.S.

If grants with foreign components receive funding, the NIH will disaggregate the application post‑review: The U.S. institution will receive a primary award, while each foreign component will receive a distinct grant number with a Linked International Research Project Grant (RF2) or Linked International Cooperative Agreement (UL2) activity code. Just-in-Time Information will be collected separately for domestic and foreign awardees, and each organization will be held accountable for fulfilling their individual terms and conditions. The foreign components will draw their funds directly from the Department of Health and Human Services payment management system, allowing for direct monitoring and oversight. Additional details regarding performance reporting are still forthcoming.

As expected, the new NIH policy described a plan to evaluate all international collaborations independently, giving the NIH the option to directly fund all, none, or some of an application’s foreign components. The new NIH Deputy Director for Extramural Research, Jon Lorsch, told STAT, “It’s something that had been a long time coming.” But the policy announcement lacked key details about how researchers should submit proposals under this new system, how the possible unique contributions of foreign components will be evaluated, or when it will go into effect. The NIH stated in the notice they will be developing and posting resources, including FAQs, as well as planning training for applicants on the new application structure with more details to come.

AACR and FDA Release “Strategies for Optimizing Dosages for Oncology Drug Products” Article Series

-Brad Davidson

On Thursday, October 2, the American Association for Cancer Research (AACR) and the U.S. Food and Drug Administration (FDA) released the FDA-AACR Strategies for Optimizing Dosages for Oncology Drug Products article series. This three-part series builds on a 2024 workshop co-led by the AACR and FDA that gathered stakeholders from industry, academia, government, and patient advocacy groups to discuss ways to make progress in oncology dosing optimization.

Traditionally, the dosage of oncology drugs has been determined by their maximum tolerated dose (MTD), or the dose that does not cause dose-limiting toxicities over a short observation period. This dose is identified early in first-in-human clinical trials, is used in subsequent clinical trials, in premarket applications seeking approval from the FDA, and is eventually the dose recommended for patients. This approach has been routinely applied for cytotoxic chemotherapeutics, where higher dosages generally yield more efficacy as well as toxicity. However, it is less suited for modern precision oncology and immunotherapy drugs, where excessive dose escalation may only add additional toxicity with no additional therapeutic benefit. As a result, many regulators, researchers, health care providers, patients, and advocates, have been pushing back against this paradigm in favor of one that incorporates more diverse data into dosing decisions.

Novel approaches to oncology dosing that utilize the totality of data accumulated throughout drug development can help determine more optimized dosages that minimize the risk of underdosing, leading to exposure to subtherapeutic dosages, as well as overdosing, leading to unnecessary toxicities. However, these approaches remain underutilized, due in part to their perceived complexity. The FDA-AACR Strategies for Optimizing Dosages for Oncology Drug Products article series addressed this issue by providing concrete examples of development programs that have successfully employed a variety of dosing optimization approaches that generate and incorporate datasets broader than just toxicity. Each of the three manuscripts in the series focuses on approaches to make more nuanced dosing decisions at a specific stage of drug development.

The first article, Selecting Dosages for First-In-Human Trials, highlights the crucial role of initial dosing decisions in facilitating a smooth process. It outlines how nonclinical data and clinical data from previous similar therapeutics can be used to inform dosing early on, but if such data is lacking, various modeling and simulation techniques can be used to fill in the gaps. Additionally, it emphasizes the strengths of novel model-informed dose-finding clinical trial designs that statistically guide dosing recommendations in real-time, maximizing patient safety, potential efficacy, and information gained.

The second article, Early Phase Trials Using Innovative Trial Designs and Biomarkers, outlines the importance of and provides strategies to select dosages for further exploration. This is in light of FDA’s recommendation in a recent guidance to directly compare the safety, activity, and tolerability of multiple dosages to support the selection of a specific dose. While FIH trials can lay the groundwork for this selection, they provided limited data to help choose doses to include in this proof-of-concept study. As highlighted in this article, additional approaches, including novel trial design features including biomarkers, backfill cohorts, and expansion cohorts can help fill out these gaps in the data. Then, modeling approaches such as clinical utility index (CUI) can quantitatively combine all the data generated up to this point in drug development and make informed decisions about doses of interest.

The third article, Selecting Optimized Dosages for Registrational Trials, focuses on the final dosing decision ahead of a registrational trial, which seeks to support FDA approval of a drug and typically compares the drug being studied at a single, theoretically most optimized dose against standard of care. The article highlights modeling techniques that evaluate both safety and efficacy data, can extrapolate the effects of doses and dose schedules not clinically tested, and can address confounding factors such as concomitant therapies to select well-informed dosages ahead of these important trials. Additionally, it highlights late-stage trial designs, including adaptive trial designs that combine multiple phases of development into one trial, as a potential way to gather more data about the most optimized dose of the drug at hand.   

A major recurring theme of the articles is that all relevant data collected can play a role in dosing decisions. Each development program must adapt not only to the drug being tested, but also the relevant patient population. In the future, in order to better serve patients, approaches to dosing for oncologic drug products should be fit-for-purpose instead of the traditional one-size-fits all approach of MTD. Learn more in a blog post on Cancer Research Catalyst, the official blog of the AACR.

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

The Scientist↔Survivor Program (SSP) 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 Annual Meeting.

Scientist↔Survivor Program Application

Advocate Partners Pavilion Application

Questions may be directed to [email protected].

Recordings Available for FDA-AACR Workshop: Approach to Novel Oncology Endpoint Development

The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence and the American Association for Cancer Research (AACR) co-hosted a hybrid workshop titled “Approach to Novel Oncology Endpoint Development” on Thursday, September 11, to discuss what has been learned from the development of previous oncology early endpoints and how future endpoint development can be best facilitated. Nearly 2000 people from around the world attended the workshop across in-person and virtual platforms, underscoring both FDA and the oncology community’s strong commitment to accelerating safe and effective drug development.

A recording of the workshop along with the slide deck are now available on the workshop webpage. A summary blog is also available on the AACR’s blog, Cancer Research Catalyst.

Patient Advocates at the 18th AACR Conference on the Science of Cancer Health Disparities

The 18th AACR Conference on the Science of Cancer Health Disparities featured a robust patient advocacy presence, including 16 patient advocate speakers integrated into the scientific program. Keynote speaker Ysabel Duron, founder of The Latino Cancer Institute, delivered remarks on the evolving role of patient advocates in cancer research and care. Seventy-four attendees registered as patient advocates or listed advocacy as a professional focus. Thirty-seven posters highlighted programs led by or developed in partnership with patient advocates, each designated with a special emblem to recognize advocate involvement. Nearly 100 participants joined two roundtable discussions focused on trust, truth, and redefining advocacy in cancer research. Two breakfast networking roundtables on community outreach and engagement featured advocate leaders Ivis C. Febus-Sampayo and Kimberly Richardson.

Oncology Approval Recap

– Brad Davidson, PhD 

Between August 29 and September 24, the U.S. Food and Drug Administration (FDA) granted three approvals for oncology drug products:

  • Gemcitabine intravesical system was approved for adults with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. Review of this product used the Real-Time Oncology Review pilot program, and the application was granted priority review and breakthrough therapy designation.
  • Selumetinib was approved for pediatric patients 1 year of age or older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas. This approval represents a broadening of a 2020 approval, which approved selumetinib in this setting for patients 2 years of age or older. At that time, selumetinib was the first therapy approved for NF1.  Selumetinib received breakthrough therapy and orphan drug designations.
  • Pembrolizumab and berahyaluronidase alfa-pmph was approved for subcutaneous injection for all solid tumor indications of the intravenous formulation of pembrolizumab for individuals 12 or older.