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Cancer Policy Monitor: June 10, 2025

Congress Presses HHS Secretary Robert F. Kennedy, Jr., Over Proposed FY2026 NIH Cuts and Layoffs

-Blake William Rostine

Throughout May, Secretary of Health and Human Services Robert F. Kennedy, Jr., appeared before the House and Senate Appropriations Committees and the Senate HELP Committee to defend the administration’s fiscal year (FY) 2026 budget proposal. These hearings surfaced widespread bipartisan concern about the impact of proposed budget reductions, staff layoffs, and halted research programs at the National Institutes of Health (NIH), including questions about how these changes could affect the future of cancer research and public health in the United States.

In May, Secretary Kennedy testified before three separate committees:

A Steep Reduction in NIH Funding

Lawmakers on both sides of the aisle questioned the administration’s proposed $18 billion cut to NIH in FY2026, by far the largest reduction in the agency’s history. In addition, several senators and representatives highlighted reports that NIH has already awarded significantly less funding this year compared to FY2024. Senator Tammy Baldwin (D-Wisconsin) noted during the Tuesday, May 20 Senate Appropriations hearing that NIH has awarded nearly $3 billion less in grants so far this year, resulting in 3,200 fewer awards.

House Appropriations Committee Ranking Member Rosa DeLauro (D-Connecticut), during the Tuesday, May 14, House Appropriations hearing, cited Senate findings that NIH research funding is down 35% year over year, including a 31% reduction in cancer research. These funding shortfalls, several members emphasized, are not hypothetical future risks. They are already having an impact on laboratories and patient care.

Terminated Grants and Delayed Trials

Many lawmakers raised concern about reports of canceled grants and delayed clinical trials. Senator Dick Durbin (D-Illinois) stated that over 1,600 grants and 240 clinical trials have already been terminated. Senator Patty Murray (D-Washington) shared the story of a stage 4 cancer patient in her state whose clinical trial participation was delayed by four weeks due to staff cuts at NIH. “For patients like Natalie, this delay could mean the difference between life and death,” she said.

Although Secretary Kennedy did not dispute the figures presented, he maintained that the Department was focused on eliminating waste and improving efficiency. He repeatedly emphasized the need to “do more with less,” though many lawmakers remained unconvinced that life-saving research programs could continue under such drastic cuts.

Layoffs and Reorganization Plans

Another focus of the hearings was the decision to reduce HHS staff by nearly 20,000 employees. Kennedy confirmed that agency-wide staffing had been reduced from 82,000 to 62,000 as part of what he described as a necessary realignment. He stated that many functions had been transferred to a newly created entity, the Administration for Healthy America (AHA), although he declined to provide additional details, citing a court order temporarily halting the reorganization.

Members of Congress pressed for greater transparency, particularly regarding the impact of the layoffs on research continuity and grant administration. Representative Lois Frankel (D-Florida) noted that many staff were still on administrative leave and asked whether analyses had been conducted to assess the consequences of the downsizing. Kennedy responded that the overall intent was to return the agency to 2019 staffing levels and redirect resources away from what he described as duplicative or non-essential programs.

Concerns About Indirect Cost Reimbursement

The administration’s proposal to cap NIH indirect cost reimbursement at 15% also received significant pushback. Members of both parties, including Senator Shelley Moore Capito (R-West Virginia) and Senator Patty Murray, warned that the cap could undermine the financial viability of research at universities and academic medical centers, particularly those in rural or underserved areas. Secretary Kennedy defended the proposal by comparing it to private foundations such as the Gates Foundation but acknowledged that the Department was still reviewing alternative models.

Transparency, Oversight, and Congressional Authority

A recurring theme across the hearings was congressional frustration over the lack of clarity in the administration’s spending plans. Senator Baldwin noted that the budget proposal submitted to Congress contained more than 530 asterisks in place of actual funding figures. “In no other job under the sun can you essentially leave blank how you are spending billions of dollars,” she said.

Several lawmakers also questioned whether the Department was fully complying with congressional appropriations laws. Kennedy stated that if Congress appropriates the money, “we will spend it,” and reaffirmed that HHS would not impound funds appropriated for NIH research. However, members raised concerns about discrepancies between that assurance and ongoing reports of delayed or frozen funding.

Looking Ahead

The FY2026 appropriations process will continue throughout the summer, with Congress expected to conduct further oversight of the administration’s proposed reforms. On Wednesday, May 21, House Appropriations Committee Chair Tom Cole (R-Oklahoma) released the Committee’s markup schedule, setting an ambitious goal of advancing all twelve appropriations bills through the House by the end of July. The Labor-HHS subcommittee is scheduled to consider its bill on July 21, with full committee markup expected on July 24.

Chairman Cole indicated that appropriators would aim to align closely with the topline figures outlined in the White House’s “skinny budget,” despite concerns raised by lawmakers in both parties. While Cole suggested cardinals would have flexibility within their subcommittees, he acknowledged the challenges ahead, particularly given the White House’s delay in releasing a full FY2026 budget and the likelihood that the Senate will reject the proposed cuts to non-defense discretionary programs.

These developments come as the current continuing resolution is set to expire on October 1, raising the possibility of another funding standoff in the fall. The AACR will continue monitoring the appropriations process and engaging with lawmakers to emphasize the importance of sustained federal investment in biomedical research.

Senator’s Report Outlines Damage Administration Has Done to Medical Research

-Matt Gontarchick

Senator Bernie Sander (I-Vermont), Ranking Member of the Senate Health, Education, Labor, and Pensions (HELP) Committee released a report on May 13 detailing actions that the administration has taken to negatively impact public health, including biomedical research. Assembled by HELP Committee Democratic staff, the report draws on interviews with dozens of scientists and other experts across the Department of Health and Human Services (HHS).

The report’s authors found that the administration cut funding for the National Cancer Institute (NCI) by 31%, or roughly $300 million, in the first three months of 2025 compared to the same period last year. The NCI’s parent agency, the National Institutes of Health (NIH), lost $2.7 billion in funding over the same three-month period.

Additionally, as of early April, the administration has canceled at least 715 NIH research grants worth $815 million, which has cut off funding for researchers at universities, non-profits, and hospitals across the nation. 32 of the canceled grants representing $15.1 million in funding were for cancer research.

The authors of the report also modeled the impact of the administration’s proposed 15% cap on reimbursement for indirect costs. If enacted, the caps would impact over 150,000 grants, including 884 grants for cancer research that total over $1 billion in lost funding.

Other sections of the report analyze the impact of the administration’s dismissal of federal workers across HHS. Of the 8,421 workers terminated so far, over 1,300 were NIH employees. This includes staff in the NIH’s clinical cell-therapy program, which has led to delays in treatment for patients with advanced cancer.  

In a statement, Sen. Sanders said, “Trump’s war on science is an attack against anyone who has ever loved someone with cancer. The American people do not want us to slash cancer research in order to give more tax breaks for billionaires.”

AACR-AACI Joint Hill Day Draws Record Turnout Amid Heightened Threats to Cancer Research

– Blake William Rostine

On Thursday, May 22, the American Association for Cancer Research (AACR) and the Association of American Cancer Institutes (AACI) brought over 150 cancer center leaders, clinicians, researchers, survivors, and advocates to Washington, D.C., for a record-setting Joint Hill Day. At a time of growing uncertainty for federal research funding, attendees delivered a unified message to Congress: Sustaining investment in the National Institutes of Health (NIH) and National Cancer Institute (NCI) is essential to saving lives, accelerating cures, and preserving America’s global leadership in science and innovation.

Participants held more than 150 meetings with congressional offices, including high-level engagements with lawmakers such as Senators Chuck Grassley (R-Iowa), Jack Reed (D-Rhode Island), Tammy Baldwin (D-Wisconsin), and Chris Van Hollen (D-Maryland). These meetings underscored the lifesaving return on federal investment in cancer research and the urgency of maintaining that momentum in the face of proposed budget cuts and increasing instability across the research landscape.

In conjunction with the Hill meetings, the AACR and AACI, in partnership with the House Cancer Caucus, hosted a congressional briefing titled “Protecting a Bipartisan Legacy: Advancing Cancer Research, Saving Lives, Securing the Future.” Moderated by Dr. Robert Winn and featuring leading voices from the research and advocacy communities, the briefing highlighted how decades of bipartisan support have driven meaningful progress against cancer. Also at the briefing, Representative Debbie Wasserman Schultz (D-Florida), a cancer survivor and longtime champion of research funding, emphasized that cancer is not a partisan issue but a deeply personal one that touches every family. Her remarks underscored the importance of keeping cancer research above politics.

MAHA Commission’s First Report Reveals Priorities of the Administration’s Health Agenda

On Thursday, May 22, the Make America Healthy Again (MAHA) Commission released its inaugural report, offering the clearest indication yet of the administration’s long-term health priorities. Led by HHS Secretary Robert F. Kennedy, Jr., the commission’s report emphasizes nutrition, environmental exposures, and skepticism of conventional medical treatments, including vaccines.

Titled Make Our Children Healthy Again: Assessment, the 68-page report describes today’s youth as the “sickest generation” in American history and blames corporate influence, ultra-processed foods, environmental toxins, screen time, and overmedicalization for rising rates of chronic disease. The report calls for sweeping changes to school meals, SNAP purchasing rules, and even the federal Dietary Guidelines for Americans.

In a controversial move, the report also advocates for additional studies on vaccine safety and efficacy, suggests removing liability protections for manufacturers, and raises questions about the CDC’s recommended childhood immunization schedule. These proposals have drawn strong backlash from public health experts and advocacy organizations.

The report calls for the EPA and NIH to expand research on cumulative chemical exposure, PFAS, fluoride, and food additives. It also questions electromagnetic radiation from smart devices and criticizes social media companies for restricting content about vaccine risk.

At the White House event unveiling the report, Kennedy praised President Trump for “standing up to industry,” while Agriculture Secretary Brooke Rollins announced plans to allow states to restrict the purchase of soda and candy through SNAP benefits. Meanwhile, critics warn that many of the report’s assertions lack scientific consensus and could undermine evidence-based public health policy.

While the commission claims to emphasize transparency and prevention, the administration has yet to disclose the full list of MAHA members. The commission held its only meeting behind closed doors, and HHS has offered little information on how its recommendations will be implemented.

Senate Forum Highlights Impact of Mass Firings at HHS

-Matt Gontarchick

On May 20 and 21, Senators Tammy Baldwin (D-Wisconsin) and Peter Welch (D-Vermont) convened a two-day forum to examine the human harm caused by the administration’s sweeping reorganization of the Department of Health and Human Services (HHS). Titled “Trump’s Destruction of HHS: Mass Firings, Reorganization, and the Human Harm Caused,” the forum featured testimony from former leaders of key health agencies, including the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and Centers for Medicare and Medicaid Services (CMS).

The witnesses described a public health system in crisis, with thousands of career scientists and civil servants fired, major research and grantmaking functions suspended, and essential services jeopardized. Several panelists focused specifically on how the disruption is affecting medical research, particularly for patients with cancer and other life-threatening diseases.

Dr. Jeremy Berg, former Director of the National Institute of General Medical Sciences at the NIH, explained that even short-term delays in clinical trials can result in their cancellation, particularly for cancer patients with no other treatment options. He testified that the termination of grants management staff has led to widespread delays and confusion across the research ecosystem, including at cancer centers and academic institutions across the country.

Dr. Anne Schuchat, former principal deputy director of the CDC, warned of lasting global consequences. She noted that reduced federal funding and scientific instability could trigger a “brain drain,” driving researchers out of the country and weakening the United States’ leadership in biomedical innovation.

Senator Dick Durbin (D-Illinois), a longtime champion of the NIH, joined the forum and highlighted the bipartisan progress that has fueled medical breakthroughs over the past decade. He warned that the administration’s proposed fiscal year 2026 budget and ongoing personnel purges would wipe out ten years of progress and undermine hopes for new cures.

“The Trump administration’s dismantling of critical programs and agencies at HHS is hurting Americans of every age in every zip code,” said Senator Welch. “From Meals on Wheels to lifesaving research, this administration is destroying the systems that deliver quality health and prevention to millions of patients.”

Senator Baldwin echoed those concerns, emphasizing that the damage will be felt by families across the country. “Their reckless cuts are putting cures further out of reach. Their reckless cuts are putting mental health support and affordable caregiving further out of reach. The list goes on, and the impacts only get worse,” she said.

As Congress begins work on fiscal year 2026 appropriations, Senators Baldwin and Welch pledged to continue pressing for answers and accountability. Their forum offered a sobering look at what is already being lost and a clear call to action to protect the future of public health and medical science.

Watch the Senate Forum on HHS Day 1.

Watch the Senate Forum on HHS Day 2.

Senators Collins and Baldwin Introduce Bipartisan Bill to Expand Access to Lifesaving Cancer Screenings

Senator Susan Collins (R-Maine) and Senator Tammy Baldwin (D-Wisconsin) introduced the Screening for Communities to Receive Early and Equitable Needed Services (SCREENS) for Cancer Act. This bipartisan legislation would reauthorize the National Breast and Cervical Cancer Early Detection Program (NBCCEDP), which has not been reauthorized in over a decade.

Established in 1991, the NBCCEDP is a partnership between the Centers for Disease Control and Prevention and state health departments. It provides free or low-cost breast and cervical cancer screening and diagnostic services to women who are low-income, uninsured, or underinsured and do not qualify for Medicaid. To date, the program has served more than six million women, detected nearly 80,000 cases of breast cancer, and identified more than 25,000 premalignant breast lesions.

The SCREENS for Cancer Act would reauthorize the program at $235 million per year from fiscal year 2026 through 2030. It would also modernize the program by granting grantees more flexibility to implement evidence-based interventions and expand outreach through media campaigns, peer educators, and patient navigation. These changes are designed to ensure that underserved communities have better access to timely screening and follow-up services.

“Cancer prevention and screening programs are vital because the earlier the disease is caught, the better the prognosis,” said Senator Collins. “Our bipartisan legislation would reauthorize and strengthen this critical program, which has helped nearly 4,000 women in Maine receive a total of 8,198 screening tests over the past five years.”

“Nearly every American’s life has been touched by a devastating cancer diagnosis, and early detection is one of the best tools we have to save lives,” said Senator Baldwin. “That is why I am proud to lead this legislation with my Republican colleague to help detect cancers earlier, save lives, and ensure more Americans get the care they need at a price they can afford.”

An estimated 319,750 people in the United States will be diagnosed with breast cancer this year, and nearly 43,000 will die from the disease. Despite the proven benefits of early detection, too many individuals still lack access to timely screenings. Delayed diagnoses often lead to more advanced disease and lower survival rates, particularly in communities with long-standing barriers to care.

By expanding access to cancer screening and education, the SCREENS for Cancer Act aims to reduce these disparities, improve outcomes, and lower treatment costs. The bill has earned support from more than two dozen national organizations, including the American Cancer Society Cancer Action Network, Susan G. Komen, the Prevent Cancer Foundation, and the Oncology Nursing Society.

The AACR commends Senators Collins and Baldwin for their bipartisan leadership and ongoing commitment to public health. The SCREENS for Cancer Act represents a meaningful step forward in ensuring that lifesaving cancer screening services reach every woman, regardless of her income or insurance status.

Application Now Open: 2025–2026 FDA-AACR Oncology Educational Fellowship

Applications are now open for the 2025-2026 FDA-AACR Oncology Educational Fellowship. This part-time program is designed for early-career oncology researchers and clinicians seeking in-depth exposure to cancer drug development and regulatory science.

Fellows will participate in expert-led educational sessions covering key areas such as investigational new drugs (INDs), new drug applications (NDAs) and biologics license applications (BLAs), accelerated approval pathways, preclinical studies, clinical pharmacology, statistics, clinical trial design, biomarkers, companion diagnostics, and precision oncology. The program includes monthly virtual webinars where fellows will learn directly from professionals at the U.S. Food and Drug Administration (FDA) and the American Association for Cancer Research (AACR). Fellows will also be invited to attend the AACR Annual Meeting, taking place in San Diego, California, from April 17-22, 2026. A signature component of the fellowship is the capstone project, Project ODAC Odyssey, in which fellows will lead a simulated, in-person meeting of the Oncology Drug Advisory Committee (ODAC) at FDA’s White Oak Campus. This immersive experience recreates how sponsors present and defend a new oncology drug before ODAC and the FDA.

Eligibility Criteria:

  • Applicants must have earned an advanced degree (e.g., DO, MD, PharmD, PhD) within the last 10 years.
  • Active or pending AACR membership is required to apply.
  • Competitive applicants will possess excellent written English skills and a demonstrated interest in oncology drug development and regulatory review.
  • International candidates are welcome but are responsible for obtaining appropriate travel documentation for in-person activities.

FDA Oncology Drug Advisory Committee Weighs in on Four Therapeutics Seeking Approval

-Brad Davidson, PhD

Across a two-day U.S. Food and Drug Administration (FDA) Oncology Drug Advisory Committee (ODAC) marathon, the committee voted on various considerations for four different therapeutics seeking FDA approval for oncology indications. The committee consists of external experts who provide advice to the FDA on dilemmas in oncology drug development. While all decisions made by the committee are non-binding, the FDA generally follows their recommendations, which have potentially large implications for the future of oncology drug development.

The morning session on May 20 centered on whether the STARGLO trial, a confirmatory trial which evaluated the use of glofitamab in combination with gemcitabine-oxaliplatin for patients with relapsed/refractory diffuse large B-cell lymphoma, was applicable to U.S. populations. The trial reached its primary endpoint, providing a statistically significant overall survival benefit. However, in an 8-1 vote, committee members determined that the trial results were not applicable to U.S. populations, spelling trouble for hopes of approval in the near-term. This was based on low U.S. enrollment (9% of enrollees, or 25 patients), and a poorer response to treatment among non-Asian trial participants when compared to the Asian population. Rick Pazdur, MD, director of the FDA Oncology Center of Excellence (OCE), emphasized during the meeting that robust enrollment in the U.S. and the use of control arms with standards of care that are representative of the U.S. will be critical for future applications.  

The next session discussed the favorability of the risk/benefit profile of subcutaneous daratumumab for the treatment of patients with high-risk smoldering multiple myeloma. Smoldering multiple myeloma is a precursor condition, meaning that it is not yet cancer and, as such, clinicians generally take a wait-and-see approach, although it frequently proceeds to multiple myeloma. The use of daratumumab, which is also frequently used to treat full-blown multiple myeloma, to prevent conversion was evaluated in the AQUILA trial, which met its primary endpoint of improving progression-free survival. However, sticking points included the definition of high-risk smoldering multiple myeloma used by the AQUILA trial, which was not in line with current risk standards; the clinical meaningfulness of the progression free survival benefit observed and the immaturity of overall survival data; and the trial’s low enrollment of Black populations. In the end, the committee landed on a 6-2 vote supporting a favorable benefit-risk profile for daratumumab in this setting. Those voting in favor cited that, although this may seem like an endorsement of treating asymptomatic patients, the high risk of conversion from smoldering to full-blown multiple myeloma makes improvements in progression free survival a goal that is worth the safety tradeoffs.

In the first session on May 21, the ODAC evaluated the benefit-risk profile of UGN-102 (intravesical mitomycin) for patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). Two trials of this drug were discussed: the randomized but early-terminated ATLAS trial and the single-arm but completed ENVISION trial. Concerns centered on the lack of robust randomized comparison data which could assure the ODAC and FDA that any benefits seen were derived from treatment with UGN-102. A critical non-voting question was whether randomized trials should be required to assess the effectiveness of therapies in this clinical setting—most panelists agreed that a randomized controlled trial is the best-case scenario and should be easy to run in this disease, but many struggled to agree with requiring them. In a close 4-5 decision, the committee indicated that treatment with UGN-102 had an unfavorable benefit-risk profile. While multiple committee members cited a lack of randomized data and the heterogeneity of the patient population in this disease making it difficult to ascertain true clinical benefit as a major factor in their decisions, multiple also indicated they were confident that the drug was safe.

The final session evaluated the potential indication expansion of talazoparib plus enzalutamide to include all patients with metastatic castration-resistant prostate cancer (mCRPC). Currently, this treatment is only approved in mCRPC patients with homologous recombination repair mutations (HRRm), a response-predictive biomarker. The TALAPRO-2 trial used to support these applications found clinical benefit in both the unselected and HRRm-positive populations, although further analysis indicated that the benefit seen in the unselected population may have been driven by outsized benefit in the HRRm-positive population. This led to uncertainty regarding whether biomarker-negative patients actually experienced clinical benefit. Indicative of this trial design issue, the committee unanimously voted 8-0 that the TALAPRO-2 study data are not sufficient to conclude a favorable benefit-risk profile in patients with non-HRRm mCRPC. This signals that the indication will likely not be expanded, and that future trials of targeted therapies seeking approval in unselected populations should evaluate biomarker-negative populations to confirm benefit.

FDA Issues a Call for Public Comment on DPD Deficiency

-Brad Davidson, PhD

On May 20, the U.S. Food and Drug Administration (FDA) established a docket and requested public comment regarding the currently available information on dihydropyrimidine dehydrogenase (DPD) deficiency and the use of fluoropyrimidine chemotherapies.

DPD deficiency has been a longstanding focus of the FDA Oncology Center of Excellence (OCE). Patients with DPD deficiency have a greatly increased risk of severe and fatal toxicities upon receipt of fluoropyrimidine treatment, which led the FDA OCE to update the labels for the fluoropyrimidine chemotherapies capecitabine and 5-FU in 2022 and 2024 to encourage healthcare providers to counsel patients about DPD deficiency testing prior to initiating treatment with fluoropyrimidines. More recently, the FDA held a public workshop on this topic in collaboration with the AACR and released a first-of-its-kind safety announcement highlighting the risks of treating patients with dihydropyrimidine dehydrogenase (DPD) deficiency with fluoropyrimidines.

Discussion at the FDA-AACR workshop emphasized that DPD deficiency testing saves lives but remains infrequently used. It also became clear that there are large differences between institutions, and even between physicians within certain institutions, regarding the use of patient counseling and testing. Lack of awareness, lack of an FDA-approved or consensus test, and a lack of strong data surrounding best-practice responses to the identification of confirmed or partial DPD deficiency were among the reasons cited for the infrequent use of testing. However, many patient advocates expressed a strong preference for requiring testing, or at least a discussion of testing, prior to fluoropyrimidine initiation.

The FDA is specifically seeking information regarding: challenges patients and healthcare providers experience based on FDA’s current recommendation to only consider testing; factors that influence healthcare providers’ decision to initiate DPD testing, or initiate fluoropyrimidine treatment without testing; factors that healthcare providers consider when deciding whether and/or how to use fluoropyrimidines in patients with complete DPD deficiency; and factors that healthcare providers consider when deciding whether and/or how to use fluoropyrimidines in patients with partial DPD deficiency.

The comment period ends on June 20.

FDA OCE Initiates Project Interface to Facilitate Public Outreach and Engagement on Cancer-Related Topics

-Brad Davidson, PhD

The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) announced a new initiative, Project Interface, that will seek to “protect, promote, and advance public health by organizing interactions with the American public to share critical information related to cancer awareness and treatments.” This new undertaking will be the 17th ongoing Project at this time of writing, a body of work which includes well-regarded programs such as OCE’s dosing optimization initiative, Project Optimus; global regulatory collaboration initiative, Project Orbis; and endpoint development initiative, Project Endpoint.  

Specific outputs of Project Interface will include public meetings, such as listening sessions and panel discussions, as well as the publication of layperson-accessible information about cancer-related topics. Additionally, public organizations will be able to request meetings with FDA OCE through Project Interface, with potential topics of interest including patient and caregiver experiences, collaborations with international regulators, and best-practice strategies to promote cancer awareness and lower cancer incidence.

June is National Cancer Survivor Month

This month, we honor the more than 18.1 million cancer survivors in the United States—each a testament to the power of progress in cancer research. The American Association for Cancer Research (AACR) celebrates every individual who has faced cancer and invites you to explore how research continues to improve and extend lives.

Learn more about the science behind cancer survivorship and discover how you can make a difference.

Oncology Approval Recap

-Brad Davidson, PhD

Between April 25 and May 23, the U.S. Food and Drug Administration (FDA) granted three new approvals and two new accelerated approvals for oncology drugs.

  • The combination of avutometinib and defactinib received accelerated approval for adult patients with KRAS-mutated recurrent low-grade serious ovarian cancer who have received prior systemic therapy. This is the first approval for either of these molecules, and the first treatment specifically approved for this cancer type. This application received priority review, breakthrough therapy designation, and orphan drug designation.
  • Belzutifan was approved for individuals 12 years or older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL). This is the first FDA approval for an oral therapy for PPGL.  This application received priority review.
  • Telisotuzumab vedotin-tllv was granted accelerated approval for adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have received prior systemic therapy and whose tumor displays high c-Met protein overexpression. This is the first approval for this therapeutic, as well as the first approval for a drug in this specific pre-treated, c-Met high NSCLC patient population.
  • Retifanlimab-dlwr was approved in combination with carboplatin and paclitaxel for the first-line treatment of adults with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). It was also approved as a single agent in this same population upon disease progression or in those who experience intolerance to platinum-based chemotherapy. This is the first full approval for this therapeutic, having received accelerated approval for the treatment of certain patients with Merkel cell carcinoma in 2023. This application was granted orphan drug designation, fast track designation, and priority review.