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Cancer Policy Monitor: June 9, 2026

OMB Proposal Would Reshape Federal Grantmaking Rules

A new proposal from the Office of Management and Budget (OMB) could reshape how federal research grants are reviewed, awarded, managed, and terminated, raising concerns across the medical research community about scientific peer review, research stability, and the ability of federally funded discoveries to reach patients.

Issued May 29, the proposed rule would make sweeping changes to the government-wide regulations governing federal grants, cooperative agreements, and other forms of federal financial assistance. The proposal follows the August 2025 executive order, “Improving Oversight of Federal Grantmaking,” which directed OMB and federal agencies to revise grantmaking policies to expand oversight of discretionary awards and align federal funding decisions with administration priorities.

OMB describes the proposal as an effort to strengthen transparency, accountability, oversight, and stewardship of taxpayer dollars. For investigators and institutions supported by the National Institutes of Health (NIH), the National Cancer Institute (NCI), and other federal science agencies, however, several provisions could have far-reaching consequences. The central concern for the cancer research community is that the proposed rule could make federal research funding more vulnerable to political influence, less predictable for investigators and institutions, and more difficult to use for the scientific activities that move discoveries toward patients.

One of the most consequential provisions involves peer review. NIH and NCI rely on rigorous, expert-driven review to evaluate scientific merit and identify research with the greatest potential to advance knowledge and improve health. Under the proposed rule, senior appointees or their designees would review discretionary awards before they are issued to determine whether they align with applicable law, agency priorities, administration policies, and the national interest.

The proposed rule would also carry forward the executive order’s direction that peer review recommendations remain advisory and should not be routinely deferred to or treated as binding. Federal agencies have always retained discretion in funding decisions, but the proposal could reduce the practical weight of independent scientific review and introduce new uncertainty into a process that depends on expertise, consistency, and public trust. If funding decisions are shaped by shifting political or policy priorities rather than scientific opportunity and public health need, high-quality cancer research could be delayed, narrowed, or denied support for reasons unrelated to merit.

The proposal also raises concerns about the stability of grants after they are awarded. Under the proposal, federal awards could be terminated if they no longer support program goals, federal agency priorities, or the national interest as they exist at the time of termination. For cancer researchers, this could introduce new uncertainty into projects that have already undergone scientific review, received federal approval, and moved into implementation. Interruptions in support can affect laboratory teams, clinical trials, early-career investigators, data infrastructure, and studies focused on prevention, detection, treatment, and survivorship, while also risking the loss of prior federal investment in work that depends on continuity.

The proposal could also affect how federally funded research is published, presented, and shared across the scientific community. Under the proposal, certain publication costs, including page charges, article processing charges, and open access fees for peer-reviewed publications would be unallowable unless required by federal statute or approved in advance by the agency on a case-by-case basis. The proposal would also require express agency approval for certain conference costs and place new limits on certain membership, subscription, professional activity, public relations, and public messaging costs.

The proposal could also create new barriers for research that depends on international partners, data, or expertise. The proposed rule would establish new standards for research and development awards involving foreign entities or international components, requiring additional justification that such work is consistent with program objectives and the national interest. While the proposal does not prohibit all international collaboration, it could create new administrative barriers for research that depends on global partnerships.

The proposed rule could also create uncertainty for researchers studying differences in cancer burden, access, and outcomes, particularly where those studies intersect with areas the administration has identified for additional restrictions. The proposal includes restrictions related to certain diversity, equity, inclusion, and accessibility activities, disparate-impact theories, gender-related policies, and other areas identified by the administration. Such studies are important for understanding why some patients are diagnosed later, why access to screening or clinical trials varies, and how outcomes can be improved across communities.

Taken together, these changes could add substantial administrative complexity to a research system already facing funding delays and uncertainty. The proposed rule includes expanded applicant risk review, payment verification and justification requirements, and E-Verify obligations for recipients and subrecipients. Although OMB frames the proposal as reducing burden, many of these provisions could increase administrative demands for universities, cancer centers, hospitals, and other research institutions and slow routine grant operations.

OMB is accepting public comments on the proposed rule through July 13, 2026. AACR is reviewing the proposal closely with partners across the medical research and cancer advocacy communities to assess how it could affect federally funded research. AACR plans to submit formal comments to OMB as part of the public comment process, as well as issue a “Call to Action” so that AACR members can also submit.

Democratic Senators Voice Concern on Slow Disbursement of Grant Funding Amid Bipartisan Rejection of fy27 NIH Budget Cuts

–Matt Gontarchick

Several Democratic members of a Senate Appropriations subcommittee expressed grave concern over policies that are reducing the number of grants reaching researchers in a May 21 hearing that featured testimony from National Institutes of Health (NIH) leadership. The hearing illustrated that while bipartisan support for medical research has empowered Congress to reject the administration’s proposed budget cuts at NIH and the National Cancer Institute (NCI), other administration policies continue to prolong the uncertainty surrounding the biomedical research community. 

Despite NIH securing a $415 million budget increase for Fiscal Year (FY) 2026, Subcommittee Ranking Member Tammy Baldwin (D-WI) noted that NCI funded 334 fewer grants in 2025, a 21% decline from the previous year. Several Democratic subcommittee members cited several reasons for the decline in grants awarded, including higher multiyear funding requirements, contract-spending constraints, and extended administrative reviews of certain awards. In particular, Senator Baldwin and Appropriations Committee Ranking Member Patty Murray (D-WA) highlighted the impact of workforce reductions at NIH on the grant review process.  

Concern over delays in the distribution of funds is not limited to the subcommittee. The same day as the hearing, Senators Dave McCormick (R-PA) and John Fetterman (D-PA) sent a letter to NIH Director Jay Bhattacharya outlining the consequences of the funding slowdown and urging the agency to “move expeditiously to obligate” all funding appropriated for FY 2026. 

Democratic members of the subcommittee also voiced concerns about declining opportunities for early-stage investigators in the U.S., which Senator Baldwin directly attributed it to the uncertain funding environment. Later in the hearing, Senator Jack Reed (D-RI) cited a 20% drop in graduate enrollment at MIT and a 10% contraction in MIT’s research portfolio as evidence that geopolitical rivals like China risk outpacing America’s global scientific leadership. In response to a question from Senator Katie Britt (R-AL), Dr. Bhattacharya described his Unified Funding Strategy will let institute directors prioritize cutting-edge projects that early-career scientists are more likely to propose, thereby providing more opportunities to early-stage investigators.  

Republican senators on the subcommittee focused their remarks on other issues, namely the geographic distribution of NIH grants and rural access to clinical trials. In response to a question from Appropriations Committee Chair Susan Collins (R-ME) on potential alternatives to the administration’s proposed 15% cap on reimbursement of indirect costs (IDCs), Dr. Bhattacharya emphasized a proposal to de-link support for facilities via IDCs from grant success. Implying a desire to improve geographic diversity of grantees, he added that roughly 20 institutions—the majority of which are located on the coasts—receive about one-third of NIH facilities support because the current system disincentivize investment in smaller institutions away from the coasts.  

Expanding on the concept of geographic diversity, NCI Director Anthony Letai committed to working with Senator Cindy Hyde-Smith (R-MS) to support the University of Mississippi Medical Center as it pursues its NCI designation. Additionally, in response to a question from Subcommittee Chair Shelley Moore Capito (R-WV), Dr. Letai discussed how NCI Community Oncology Research Program and NCI’s National Clinical Trials Network are helping extend NCI-supported clinical trials into rural areas like West Virginia. Additionally, Senator John Boozman (R-AR) highlighted how the Institutional Development Award program has helped enhance the research capability in states such as Arkansas. 

Another topic of interest was the rise of early-onset cancer. In response to a question from Senator Boozman, Dr. Letai identified early-onset colorectal cancer as the trend that most concerns him because it is one of the few cancers where mortality is growing among young people. While the cause remains unclear, Dr. Letai said early NCI-funded microbiome research poses one of the more promising leads.  

Amid this backdrop of funding uncertainty, appropriators in both the House and the Senate are continuing to reject the administration’s calls to cut the NIH budget by 12% in FY 2027. On Friday, June 5, the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies (Labor-HHS) approved a spending bill for FY 2027 that provides $47.3 billion in base program funding, a $100 million increase from FY 2026. The bill also provides NCI with $7.462 billion for FY 2027, marking a $110 million increase.  

The full House Appropriations Committee is scheduled to consider its FY 2027 funding bill for Labor, Health and Human Services, Education, and Related Agencies on Tuesday, June 9. AACR is working in conjunction with the biomedical research advocacy community to urge $51.3 billion for NIH and $7.999 billion for NCI in FY 2027. 

AACR-AACI Joint Hill Day Emphasizes Ongoing Challenges in Cancer Research 

–Matt Gontarchick

The uncertainty surrounding cancer research funding was the overarching message of a Joint Hill Day that AACR conducted with the Association of American Cancer Institutes (AACI) on May 14, 2026. The Hill Day drew more than 115 cancer center leaders, clinicians, researchers, survivors, and advocates to Washington, D.C., who carried a unified message on the importance of continued federal investment in biomedical research. 

The evening prior to the Hill Day, participants, advocates, and congressional staff gathered for a reception on Capitol Hill to honor lawmakers for their continued dedication to supporting medical research. Among the members of Congress highlighted were Senators Shelley Moore Capito (R-WV) and Tammy Baldwin (D-WI), co-recipients of the 2026 Cancer Research Ally Award. The reception also featured remarks from AACR President-Elect Robert Vonderheide, MD, DPhil; AACI President Joann B. Sweasy, PhD; West Virginia University Cancer Institute Executive Chair Hannah Hazard-Jenkins, MD, FACS; and patient advocate and cancer survivor Sarah Kaehny. 

The following day, Hill Day participants attended nearly 120 meetings with congressional offices, including high-level engagements with lawmakers such as Senator Jerry Moran (R-KS), Congressman Ed Case (D-HI), Congressman Shri Thanedar (D-MI), and Congresswoman Maggie Goodlander (D-NH). Over the course of these meetings, advocates thanked lawmakers and their staff for rejecting the administration’s proposed 40% budget cut to NIH in FY 2026 and urged Congress to reject the proposed 12% funding cut for FY 2027. Advocates also highlighted the ongoing uncertainty facing the biomedical research community with regards to the slow disbursement of appropriated funds for extramural research and the increased rate of multi-year funding. According to participants, these policy changes have resulted in thousands of fewer NIH grants being funded, leaving researchers and patients in limbo. 

In conjunction with the Joint Hill Day, AACR conducted an advocacy campaign to urge members and advocates to contact lawmakers and reject the administration’s proposed cuts to medical research. The campaign drew nearly 200 participants who sent more than 580 messages to congressional offices in support of robust, sustained, and predictable investments in NIH and NCI. 

Cancer Advocacy Groups Urge HHS Secretary Kennedy to Protect the Integrity of the U.S. Preventive Services Task Force 

–David Zahavi, PhD

The U.S. Preventive Services Task Force (USPSTF) is an independent panel of national experts in disease prevention and evidence-based medicine that develops recommendations on a wide range of clinical preventive services, including cancer screenings, tobacco cessation interventions, and other measures designed to prevent or detect cancer. Under the Affordable Care Act, many USPSTF recommendations directly determine which preventive services private health insurers must cover without patient cost-sharing, making the Task Force a critical driver of access to evidence-based cancer prevention and early detection services nationwide. 

Concerns about the stability and independence of the USPSTF have intensified in recent months amid significant disruptions to the task force’s operations and leadership. The USPSTF, which typically holds three meetings a year, has not convened since March 2025. More recently, on May 11 the Department of Health and Human Services (HHS) announced the removal of two USPSTF vice chairs, a move that comes amidst HHS Secretary Kennedy’s broader push to reform the panel. 

In response to these latest moves, a coalition of 60 organizations representing millions of cancer patients, survivors, and healthcare providers including AACR recently sent a letter to HHS Secretary Kennedy underscoring the critical role of the USPSTF in cancer prevention and early detection and urging the administration to protect the integrity of its work. In the letter, the organizations emphasized that more than 2 million Americans are expected to be diagnosed with cancer this year and highlighted how USPSTF recommendations help save lives by detecting cancer earlier, when treatment is more effective and less invasive. The letter urged HHS to preserve the scientific rigor, independence, and evidence-based approach of the USPSTF and warned that continued disruptions to its vital work will weaken national efforts to reduce the burden of cancer and other chronic diseases. 

AACR To Release Fourth Editon of Cancer Disparities Progress Report on June 24 

–David Zahavi, PhD

Please join the American Association for Cancer Research® (AACR) on Capitol Hill on Wednesday, June 24, from 12-1:30 p.m. ET in room SD-106 of the Dirksen Senate Office Building for a congressional briefing as AACR leaders unveil the AACR Cancer Disparities Progress Report 2026 and patient advocates featured in the report share their experiences with cancer to drive public policy change. This fourth edition of the landmark AACR Cancer Disparities Progress Report highlights the latest research on the driving forces behind disparities in cancer incidence, treatment, and outcomes across the United States. The report also outlines evidence-based solutions to eliminate disparities and advance equitable cancer care for all populations. 

Registration for the livestream can be found online. 

The High Turnover Rate For FDA Leadership Continues 

–Brad Davidson, PhD

Marty Makary, MD, resigned from his role as FDA Commissioner in mid-May. He has been replaced on an acting basis by Kyle Diamantas, JD, a regulatory lawyer who was previously leading FDA’s foods division. Soon after, the leaders of both major drug centers, the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), were also removed from their posts. Tracy Beth Høeg, MD, PhD, was replaced as acting director of CDER by Deputy Director Mike Davis, MD, PhD, a psychiatrist who previously served in CDER’s Office of New Drugs from 2016-2022. Meanwhile, Karim Mikhail, a pharmaceutical company executive who turned FDA senior advisor in 2025, will lead CBER on an acting basis after the reassignment of Katherine Szarama, PhD.  

Makary’s tenure was notable for, among other things, a clear desire to modernize drug development. Makary’s primary initiatives, including the Commissioner’s National Priority Voucher (CNPV) Program, Real-Time Clinical Trials pilot program, Roadmap to Reducing Animal Testing in Preclinical Safety Studies, and a much discussed but not-yet-released project to streamline investigational new drug (IND) applications, all had and continue to have the potential to accelerate the pace of drug development. It has been reported that such initiatives are expected to continue after his departure.  

The high levels of staff turnover that also marked Makary’s tenure were also unprecedented. Davis is now the sixth leader of CDER in the last year and a half, an amount of change matched only by the departure of leaders and staff throughout other parts of FDA. For example, it has been reported that the FDA Oncology Center of Excellence (OCE) began this administration around 100 clinical reviewers and is now down to around 50, with hematology and breast review teams experiencing a noted loss.  

Searches have begun for the future leaders of the FDA. While many names have been posited, no clear frontrunners have emerged. Although highly unlikely by his own admission, Rick Pazdur, MD, former head of CDER and the OCE, was the subject of a supportive letter by a conglomeration of industry representatives as a potential next commissioner. The next commissioner will need to be confirmed by the Senate, adding an extra layer of complication ahead of any candidate, especially since multiple other health-facing roles have been awaiting confirmation over the recent months including Erica Schwartz, MD, JD, to lead the Centers for Disease Control and Prevention and Nicole Saphier, MD, as Surgeon General. 

FDA Releases Slew of Flavored Vaping Policies 

–Brad Davidson, PhD

In March of this year, FDA released a draft guidance outlining that some flavored electronic nicotine delivery systems (ENDS), including e-cigarettes, may be appropriate for public health if they generate only a low risk to youth, counterweighted by a small benefit to adults. Up to that point, despite receiving thousands of applications for flavored e-cigarette products, FDA had not signaled a willingness to authorize flavored products outside of tobacco or menthol. In the middle of the open comment period for this guidance, a process where the public is typically allowed to provide input on upcoming regulatory actions, FDA authorized the first ever flavored products, which were mango and blueberry flavored. Many advocacy organizations decried this step, especially as fruit-flavored products are widely reported as the most dangerous to youth.  

Days after this authorization, FDA released another guidance, this time without an open comment period, regarding when FDA does not intend to prioritize enforcement against illegal tobacco products such as most flavored e-cigarettes. Specifically, FDA stated that “FDA does not intend to prioritize [enforcement] if a product has a pending application that has been accepted and filed, or when a manufacturer has a pending and accepted Supplemental PMTA, and if FDA has determined the application includes data necessary to evaluate whether the product is appropriate for the protection of public health in the case of non-tobacco flavored ENDS products.” The only carveout of this statement, where products would still be prioritized for enforcement, were products that are marketed to look like everyday products or to be youth-appealing, such as when they are masquerading as candy or video games. FDA subsequently issued warning letters to companies selling products doing so.  

These policy moves coincide with the resignation of FDA Commissioner Marty Makary, MD, whose resignation reportedly stemmed in part from his opposition to authorizing flavored ENDS products. AACR has long held a stance that flavored e-cigarettes should not be authorized unless they have shown a proven benefit to adults who smoke by helping them quit. AACR restated this position in a comment letter to the aforementioned guidance on appropriateness of flavored ENDS products. These recently approved products have not met that standard. Additionally, these policy actions taken by FDA work directly against its own previous efforts to establish an e-cigarette enforcement task force, as well as the requests of bipartisan legislators who have long called for greater enforcement against illegal tobacco products.  

Shifts in Immigration Policy Are Undermining the U.S. Cancer Research and Care Workforce 

–David Zahavi, PhD

America’s leadership in cancer research and patient care depends on a robust workforce of scientists, clinicians, and physician-scientists. The United States has long been the premier destination for education, training, and research and has attracted top talent from around the world to establish laboratories, run clinical trials, invent breakthrough therapies, and deliver care to underserved communities. However, recent and ongoing changes in immigration policy are disrupting this pipeline and will have major impacts on the cancer research and care workforce. 

Academic medical centers and federally funded research institutions are foundational to scientific discovery. Recruitment and retention of international talent is a major contributor to the science, technology, engineering, and medicine (STEM) workforce and a driving force behind innovation. Foreign-born scientists make up a large portion of doctoral degrees in STEM and are vital to maintaining the U.S.’s biomedical edge. Recent changes to U.S. immigration policy, including the Trump administration’s September 2025 announcement of a new $100,000 fee on certain H-1B visa petitions, have created significant uncertainty for cancer research institutions and academic medical centers that rely heavily on international scientists and physician-researchers, many of whom transition to careers in the U.S after completing training. In addition, smaller academic labs and nonprofit research institutions have been particularly impacted because they often lack the financial flexibility to absorb large immigration-related expenses. 

When immigration uncertainty and restrictive visa environments make recruitment or retention difficult, laboratories lose scientific capacity and are unable to conduct the most groundbreaking research. A recent STAT News survey of nearly 1,000 NIH-funded U.S. researchers revealed that 14% reported immigration policy changes have already forced scientists, students, or postdocs to turn down job offers, and a similar share noted that their labs had lost researchers to opportunities abroad. These trends indicate that the policy climate surrounding immigration are having chilling effects on the biomedical research workforce. 

In addition, the U.S. healthcare system depends on foreign-born doctors, nurses, and other healthcare providers, especially in rural and medically underserved communities. Many non-U.S. citizen physicians who attended medical school in their home country before coming to the U.S. to complete their training through residency and fellowship remain in the U.S. as clinicians in areas of great need. The J-1 visa waiver program, run by the Department of Health and Human Services, allows non-U.S. citizen physicians to stay in the country after they complete their training if they agree to work in underserved areas for at least three years. But recent reports indicate that delays to that program have threatened this pipeline. Without a J-1 waiver, these physicians must return to their home countries and then find an employer to pay the $100,000 fee now associated with the H-1B work visa. Despite strong advocacy from hospitals and healthcare organizations urging the administration to exempt physicians and other healthcare workers from the fee, no such exemption has been granted to date. Without timely waivers, hundreds of clinicians may be forced to leave the U.S., potentially disrupting care for vulnerable populations and worsening provider shortages. 

Cancer research is poised for breakthroughs in immunotherapy, genomics, and precision oncology and ambitious programs in early-phase trials, translational science, and population health research depend on a steady influx of talented researchers at all career stages from around the world. Restrictive immigration policies and delays or deterrents to visas for STEM trainees and physicians are beginning to disrupt the biomedical workforce pipeline and leave key positions unfilled. The U.S. must prioritize sustainable immigration policy, reinstitute timely J-1 visa waivers, and remove financial barriers to H-1B visas to preserve its global leadership in biotechnology and medicine and sustain progress against cancer for patients nationwide. 

AI-Generated Citations Raise Concerns for Scientific Literature Integrity 

–David Zahavi, PhD

As large language models and generative artificial intelligence (AI) tools become increasingly commonplace, concerns are growing about the rise of inaccurate or fabricated citations in academic papers. Generative AI can produce authoritative sounding but inaccurate information, including false references or distorted summaries of published findings. In cancer research, where scientific rigor and reproducibility are essential for guiding clinical trials, regulatory decisions, and patient care, unreliable citations could undermine literature reviews, meta-analyses, and future research efforts. 

A recent study published in the Lancet and reported on by STAT News identified a sharp six-fold increase in suspicious citations, including references to nonexistent or misattributed studies, between 2023 and 2025. The study authors are sounding the alarm that AI-generated “hallucinated” references may be entering the scientific literature. The issue of AI-generated citations comes amid broader concerns about research integrity and reproducibility. A priority of NIH Director Bhattacharya has been strengthening replication and reproducibility of NIH-funded research, leading to the launch of an agency-wide initiative to elevate replication and reproducibility studies. And in July of 2025, NIH issued new guidance that grant applications found to be substantially developed by AI would not be considered for funding.  

While AI tools can improve efficiency, readability, and accessibility in scientific writing, research organizations and publishers are increasingly emphasizing that investigators remain fully responsible for verifying citations and ensuring accuracy and that improper use of AI will be considered research misconduct. While many journals have instituted safeguards to catch fabricated citations, additional policies requiring disclosure of any AI use and strengthening editorial oversight to detect problematic references before publication are needed. Fostering transparency, accountability, and rigorous citation verification will be critical to preserving trust in the scientific literature and advancing progress against cancer. 

Register Now: 14th Annual Rally for Medical Research 

The 14th Annual Rally for Medical Research will be held September 16-17, 2026, in Washington, D.C. The Rally brings together advocates from around the country to call upon the nation’s policymakers to make funding for the NIH a national priority and bring attention to the importance of stable and robust investments in medical research. The Rally for Medical Research comes at a crucial time for the medical research advocacy community as the White House has proposed a 12% cut to the NIH budget.   

Both a participant training and a reception for advocates will be held on September 16, followed by the Rally Hill Day on September 17, in which participants will meet with congressional offices.  

Join the 77% of Americans who oppose medical research cuts by registering for the lobby day and booking your room in the hotel block today. Please contact Rally organizers with any questions. 

June is National Cancer Survivor Month 

This month, we honor more than 18.6 million cancer survivors in the United States—each a testament to the power of progress in cancer research. AACR celebrates every individual who has faced cancer and invites individuals to explore how research continues to improve and extend lives. AACR is dedicated to continued research on issues surrounding survivorship, so that even after cancer treatment, survivors can have the highest quality of life possible.  

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

Application Open: Scientist↔Survivor Program® 2027 

AACR is now accepting applications for the 2027 Scientist↔Survivor Program® (SSP) which will be held during the AACR Annual Meeting in Orlando, Florida, April 2-7, 2027. 

The 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.  

Questions may be directed to [email protected]. 

FDA-AACR Oncology Educational Fellowship Application Opening on June 15 

The FDA-AACR Oncology Educational Fellowship is a program for early career cancer researchers and clinicians designed to increase their experience with oncology drug development and the regulatory review process through targeted educational activities and interactions with experts from AACR and the FDA Oncology Center of Excellence. 

Over the course of one year, fellows will participate in virtual educational events on topics to include, among others: INDs, NDAs/BLAs, expedited pathways, clinical pharmacology, biostatistics, clinical trial design, companion diagnostics, novel endpoints, and precision oncology. Fellows are also provided with travel and lodging assistance to attend two in-person events: the AACR Annual Meeting and a capstone event known as Project ODAC Odyssey at the FDA White Oak Campus. The application period for the 2026-2027 edition of the fellowship opens on June 15 and will close on August 3. Please see this additional information.  

Oncology Approval Recap 

–Brad Davidson, PhD

Between April 23 and May 28, FDA approved 12 new indications for cancer therapeutics, including 4 novel therapeutics: 

  • Durvalumab was approved in combination with Bacillus Calmette-Guerin (BCG) for the treatment of adult patients with BCG-naive, high-risk non-muscle invasive bladder cancer.  
  • Pivekimab sunirine-pvzy was approved for adults with blastic plasmacytoid dendritic cell neoplasm. This application was granted priority review, and this therapeutic received breakthrough and orphan drug designations.  
  • Datopotamab deruxtecan-dlnk was approved for adult patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy. Review was conducted under Project Orbis, in collaboration with the Australian Therapeutic Goods Administration (TGA), the Brazilian Health Regulatory Agency (ANVISA), Health Canada, Singapore’s Health Sciences Authority (HSA), and Switzerland’s Swissmedic. This application was also granted priority review.  
  • Fam-trastuzumab deruxtecan-nxki was approved for two indications. First, it was approved followed by a taxane, trastuzumab, and pertuzumab for the neoadjuvant treatment of adults with HER2-positive stage 2 or 3 breast cancer. Second, it was approved for the adjuvant treatment of adults with HER2-positive breast cancer who have residual disease following neoadjuvant treatment with trastuzumab with or without pertuzumab and taxane-based treatment. Reviews of both indications were conducted under Project Orbis, and were collaborations with the TGA, ANVISA, Health Canada, Switzerland’s Swissmedic, HSA, the United Kingdom’s Medicines and Healthcare products Regulatory Agency, and the Israel Ministry of Health. The application for the adjuvant indication was granted priority review and the breakthrough designation. 
  • Atezolizumab and atezolizumab hyaluronidase-tqjs were approved as an adjuvant treatment for adults with muscle invasive bladder cancer who have circulating tumor DNA molecular residual disease after cystectomy. This application was granted priority review.   
  • Decitabine and cedazuridine tablets were approved with venetoclax for the treatment of newly diagnosed acute myeloid leukemia in adults 75 years or older who have comorbidities that preclude the use of intensive induction chemotherapy. Review was conducted under Project Orbis in collaboration with Health Canada, and this product received the orphan drug designation.  
  • Sonrotoclax received accelerated approval for adults with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor. Review was conducted under Project Orbis in collaboration with the European Medicine Agency.  
  • Zenocutuzumab-zbco was approved for adults with advanced, unresectable, or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. This application was part of the FDA Commissioner’s National Priority Review Voucher (CNPV) pilot program and was granted priority review.  
  • Vepdegestrant was approved for adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. 
  • Relacorilant was approved in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab.