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Cancer Policy Monitor: July 8, 2025

Senators Question NIH Director on Proposed Cuts to NIH in FY2026 Budget 

-Matt Gontarchick 

National Institutes of Health (NIH) Director Jay Bhattacharya faced questions from senators on the administration’s proposal to drastically cut NIH’s budget in a June 10 Senate appropriations subcommittee hearing. In each instance, Bhattacharya responded by saying that the budget proposal is part of a “collaboration” between Congress and the administration, and that he looks forward to working with lawmakers as they negotiate spending bills. 

Throughout the bipartisan hearing, both Democratic and Republicans senators spoke on the importance of NIH-funded research. Senator Jerry Moran (R-Kansas) shared that finding new cures and treatments is one of the reasons why being a senator is so valuable to him, while Senator Katie Britt (R-Alabama) voiced a commitment to ensuring that NIH remains the gold standard of research. Additionally, Senator Patty Murray (D-Washington) noted the Appropriations Committee’s strong bipartisan history of strengthening investments in NIH to support lifesaving research. 

In its Fiscal Year (FY) 2026 budget request, the White House proposed a reduction in NIH’s base budget from its current FY 2025 level of $47 billion to $27 billion, which amounts to a 40% cut. The proposed cuts drew criticism from members of both parties. Senator Susan Collins (R-Maine), chair of the Appropriations Committee, said the budget request would “undo years of congressional investment in NIH, while Senator Tammy Baldwin (D-WI) warned that the proposed cuts could “dismantle the U.S. biomedical research enterprise.” 

Senator Brian Schatz (D-Hawaii) joined Collins and Baldwin in voicing concerns that cuts to the NIH budget would drive young researchers abroad and allow competitors such as China to replace the U.S. as the global leader in biomedical research. Bhattacharya addressed these concerns by voicing the administration’s commitment to ensuring that the U.S. continues to lead the world on publicly funded science, and he surmised that young researchers are likely to remain in the U.S. due to the number of resources available to them. 

Furthermore, Senator Dick Durbin (D-Illinois) joined Murray, Baldwin, and Schatz in criticizing the termination of NIH grants, which Baldwin said has impacted over 2,370 grants totaling $4.9 billion in funding. According to Bhattacharya, the NIH is primarily responsible for grant terminations intended to “move away from politicized science,” while both the NIH and the administration collaborated on other terminations. Bhattacharya also explained that since the establishment of an appeals process for terminated grants at the NIH, hundreds of appeals have been made resulting in the reversal of many terminations. However, Bhattacharya did not provide an exact figure on the number of reversed terminations and the timeline for reviewing appeals. 

Collins also reproached Bhattacharya for the proposal to cap reimbursement of indirect costs at 15%. While the NIH director declined to discuss the proposed cap due to ongoing litigation, he asserted a need to reevaluate how the federal government reimburses grant recipients on direct costs. Senator John N. Kennedy (R-LA) defended the cap, noting that the Gates Foundation has a similar reimbursement rate for indirect costs. 

The administration’s FY 2026 budget request additionally drew criticism from Baldwin regarding a proposal to “forward-fund” grants by giving grantees all of their funding upfront instead of incrementally over a multi-year period. She contended that the new funding mechanism would put billions of dollars in escrow and result in 4,000 fewer research grants being awarded next year. In response, Bhattacharya said forward-funding would allow more money to be spent on more projects in the long run while “allowing more flexibility as new scientific opportunities come up,” although he stressed that the details of the transition from the old funding model the new one would be important. 

The AACR strongly opposes the administration’s proposal to drastically cut the NIH’s budget. As the appropriations process moves forward in Congress, the AACR remains committed to ensuring robust, sustained funding for the NIH that will support the next generation of breakthrough cancer treatments. 

Hundreds of NIH grant terminations are “void and illegal,” federal judge rules   

-Carly McCallie 

A federal judge in Massachusetts has ruled that the National Institutes of Health (NIH) acted unlawfully in terminating hundreds of biomedical research grants, declaring the cancellations “void and illegal.” The decision was issued on Monday, June 16, by Judge William G. Young, and it applies to approximately 900 grants identified in lawsuits filed by researchers, professional organizations, and a coalition of 16 states. The judge also ordered the federal government to reinstate those grants, delivering a major legal setback to the administration’s ongoing campaign to reshape NIH funding priorities. 

The lawsuits challenged the legality of widespread grant terminations that began following President Trump’s return to office. According to Grant Watch, a database tracking NIH funding activity, over 2,600 grants have been terminated to date, totaling an estimated $8.9 billion. Many of these grants focused on diversity, equity, and inclusion (DEI), health disparities, and LGBTQ+ health. These are areas the administration has targeted for elimination. 

The plaintiffs argued that the terminations violated the Administrative Procedure Act by being arbitrary and capricious and contrary to Congressional mandates. They also raised constitutional concerns, asserting that the executive branch had overstepped its authority in altering NIH funding decisions without Congressional approval. 

Judge Young, a Reagan appointee, strongly criticized the administration’s actions during the hearing, stating that he had “never seen racial discrimination by the government like this” in his four decades on the bench. He rejected the administration’s request to stay the decision, writing that “even a day’s delay further destroys the unmistakable legislative purpose from its accomplishment.” 

In response to the ruling, the NIH issued an internal memo on Wednesday, June 25, instructing staff to immediately stop all pending and future grant terminations. The directive, sent by Michelle Bulls, director of the Office of Policy for Extramural Research Administration, reads: “Effective immediately, please do not terminate any additional grant projects. Please unrelease all grant projects that are in the queue to be terminated.” The message signals a pause in the administration’s termination campaign. However, the long-term implications remain uncertain. 

Additional legal action is ongoing. On Tuesday, June 24, a separate ruling in California temporarily blocked the termination of grants to the University of California, finding that canceling research on “forbidden topics” like DEI and LGBTQ+ health likely violated the First Amendment. Although the court’s decision currently applies only to the grants identified in the lawsuits, it marks a turning point in the fight over the integrity and independence of biomedical research funding.  

As legal proceedings continue and NIH leadership evaluates its next steps, researchers, institutions, and advocates are closely monitoring whether the administration will comply with the ruling or pursue an appeal. In the meantime, the grant terminations remain suspended, offering temporary relief but not resolution to the ongoing uncertainty facing the biomedical research community. 

White House Issues Guidance on “Gold Standard Science” in Federal Research 

–Carlie McCallie

On Monday, June 23, the White House Office of Science and Technology Policy (OSTP) issued new guidance requiring federal agencies to report within 60 days on how they will incorporate “Gold Standard Science” into their research activities. The memo, signed by OSTP Director Michael Kratsios, follows President Trump’s May 2025 executive order calling for reforms in federally funded science, citing a “loss of public trust” stemming from prior COVID-19 guidance, environmental regulations, and research related to diversity, equity, and inclusion (DEI). 

The guidance outlines nine key tenets that agencies are expected to integrate across all research activities they conduct or fund. According to the memo, “By adopting these standards, agencies will strengthen scientific inquiry, rebuild public trust, and ensure the United States continues as the global leader in rigorous, evidence-based science.” 

  • Reproducibility and Replicability 

Agencies must prioritize disciplined scientific methods that allow independent confirmation of results. This includes clear protocols, validated methods, appropriate controls, adequate sample sizes, and public sharing of data and code where feasible. 

  • Transparency 

Research should be open and accessible. Agencies are expected to require detailed reporting of methodologies, disclosure of funding sources and conflicts of interest, and sharing of raw data, software tools, and peer review criteria when appropriate. 

  • Communication of Uncertainty and Error 

Scientific findings must include clear explanations of uncertainty, limitations, and potential error sources. Agencies should promote standardized ways to report these factors, such as confidence intervals, sensitivity analyses, and visual summaries. 

  • Collaboration and Interdisciplinary Research 

To address complex problems, agencies should support collaboration across disciplines, agencies, institutions, and sectors. This includes funding for interdisciplinary teams, shared infrastructure, and data integration tools. 

  • Constructive Skepticism 

Agencies must encourage researchers to question assumptions and avoid confirmation bias. This includes supporting replication studies, critical peer review, and even adversarial collaborations where opposing hypotheses are rigorously tested. 

  • Falsifiability 

Research should be structured around testable, disprovable hypotheses. Agencies should favor experimental designs that include measurable criteria for falsification, use of control groups, and practices like study pre-registration. 

  • Unbiased Peer Review 

All research proposals must be reviewed independently, using clear and consistent merit-based criteria. Agencies should ensure reviewer expertise and independence, with appropriate disclosure and management of conflicts of interest. 

  • Recognition of Negative Results 

Null or negative findings are essential to scientific progress. Agencies should require that all outcomes be reported and support platforms or journal outlets that recognize the value of these results. 

  • Scientific Integrity and Conflict-of-Interest Disclosure 

To protect the objectivity of science, agencies must enforce robust conflict-of-interest policies. This includes mandatory disclosure for researchers, reviewers, and agency officials involved in funding or conducting research. 

Agency implementation plans are due August 22. Each plan must describe how the new principles will be reflected in agency culture, funding opportunities, award selection processes, internal training, and evaluation methods. Beginning in 2026, agencies will be required to submit annual progress updates each September. 

While the memo affirms the importance of research transparency and integrity, some scientists and advocacy organizations are expressing concern about the broader context and potential implications of the initiative. 

The reference to “adversarial collaborations,” described in the memo as a tool to reduce confirmation bias, has raised concern among experts who fear a return to red team versus blue team debates over settled scientific issues, such as climate change. 

The administration’s rhetoric has framed the initiative as a corrective to what it characterizes as politicized or ideologically driven research. An HHS spokesperson stated, “Taxpayer-funded research must serve the public interest, not ideological trends or institutional complacency.” However, critics argue that actions taken under this banner, such as terminating grants related to LGBTQ+ health or health equity, suggest a different kind of political interference. 

In an op-ed on Tuesday, June 24, Director Kratsios emphasized that the new standards should apply not only to federal agencies but to the entire scientific ecosystem, including universities, journals, industry, and philanthropy. He called on the broader community to use the guidance as a model for improving the quality of research nationwide. 

As agencies prepare their reports and the research community awaits further details, the practical implications of this policy remain unclear. Supporters say the effort could enhance transparency and accountability. Detractors caution that it may instead serve to justify selective funding decisions and increase administrative burdens, all while undermining long-established principles of scientific independence. 

The first agency plans are expected by late August and will likely provide clearer insight into how the executive order will be interpreted in practice and whether it will advance or erode public confidence in federal science. 

HHS Secretary Kennedy reshapes CDC Advisory Committee on Immunization Practices (ACIP)   

-David Zahavi, PhD 

Vaccines are an important tool in the fight against cancer. Human papillomavirus (HPV) is a group of more than 200 related viruses, of which 12 high-risk HPV types are definitively known to be associated with causing cancer. Vaccination against HPV has been proven successful in preventing several types of cancer caused by HPV, including cervical, anal, throat, and penile cancers. It is most effective when given during childhood or early adolescence. Overall, data from numerous studies have found HPV vaccines a safe and powerful measure for reducing cancer rates and promoting long-term public health. Increased HPV vaccination rates through improved education, reduced cost, and vaccination programs could lead to complete eradication of HPV-related cancers in men and women. 

The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) is a federal committee comprised of medical and public health experts that reviews the safety, effectiveness, and clinical necessity of vaccines and provides recommendations on the use of vaccines in the United States. The ACIP holds three meetings each year in February, June, and October to review scientific data and vote on its recommendations. ACIP recommendations have wide-ranging impacts including influencing vaccine policies at the state and local level—such as for school immunization requirements—and for determining which vaccines must be covered by public and private insurance programs, including the Affordable Care Act and the Vaccines for Children (VFC) program. 

The FDA approved the first-generation HPV vaccine Gardasil® in 2006 and the updated vaccine Gardasil®9 in 2014. Gardasil®9 has been the only available HPV vaccine in the U.S. since 2016 and has continued to show excellent safety and effectiveness outcomes. The CDC last updated its HPV vaccine recommendations in 2019 to include routine HPV vaccination beginning at age 11 or 12 (and as early as 9) with catch-up vaccination through age 26 for all individuals (both women and men). 

On June 9, Secretary of Health and Human Services (HHS) Robert F. Kennedy, Jr., abruptly dismissed ACIP’s 17 members and replaced them two days later with his own eight handpicked choices (down to seven after one withdrew during their financial conflicts of interest review). For more than 60 years, ACIP has served as a panel selected through a rigorous process based on expertise in immunology, epidemiology, infectious diseases, relevant patient populations, and public health. HHS Secretary Kennedy’s controversial decision to entirely replace the ACIP members with individuals who have been openly critical of vaccines or have limited expertise has sparked criticism. “Although the appointees to ACIP have scientific credentials, many do not have significant experience studying microbiology, epidemiology or immunology. In particular, some lack experience studying new technologies such as mRNA vaccines, and may even have a preconceived bias against them,” Senator Bill Cassidy (R-Louisiana) wrote on X, formerly known as Twitter. In a statement, former ACIP members said, “We are deeply concerned that these destabilizing decisions, made without clear rationale, may roll back the achievements of U.S. immunization policy, impact people’s access to lifesaving vaccines, and ultimately put U.S. families at risk of dangerous and preventable illnesses.” 

ACIP was originally scheduled to meet June 25-27, with an earlier Federal Register notice including plans to discuss and vote on recommendations for a wide range of vaccines, including COVID-19, influenza, measles, mumps, rubella, varicella (MMRV), and HPV as well as related votes for the VFC program. The final agenda was revised for a shorter meeting on less vaccines, with a discussion and vote on HPV vaccine recommendations postponed until a later time. ACIP met on June 25 and 26 despite calls to delay the meeting from Senator Cassidy, who said “the meeting should be delayed until the panel is fully staffed with more robust and balanced representation—as required by law—including those with more direct relevant expertise.” In a meeting with pointed questioning revealing the panel’s deep skepticism of vaccines, ACIP ultimately voted to approve a monoclonal antibody therapy for infants to treat respiratory syncytial virus (RSV) and to remove thimerosal, a common target of the anti-vaccine movement, from flu vaccines. The American Academy of Pediatrics, which typically attends ACIP, boycotted the meeting and said it will publish its own evidence-based immunization recommendations and schedules. These moves and potential fracturing of vaccine policy have led to fears that such competing recommendations will lead to confusion and a further decline in vaccination rates.  

HHS Secretary Kennedy’s reshaping of ACIP has left the future of HPV vaccine recommendations and policy uncertain. Former ACIP chairs have warned that the U.S. risks losing access to life-saving immunizations due to HHS Secretary Kennedy’s actions. The AACR strongly supports HPV vaccination as a critical tool for cancer prevention and urges ACIP to reaffirm its evidence-based recommendations and promote HPV vaccination as safe and effective.   

Changes in Priorities and Programs Begin to Take Shape at the FDA    

-Brad Davidson, PhD  

Staffing changes, new policies, and updated priorities characterize ongoing sea change at the U.S. Food and Drug Administration (FDA). While communications lagged at the start of the year, the FDA has recently been making news nearly daily. Here, we roundup some of the top stories: 

  • As of this writing, only two FDA center leaders remain who have held their roles across the Biden and second Trump administration: Michelle Tarver, MD, PhD, of the Center for Devices and Radiological Health (CDRH), and Richard Pazdur, MD, of the Oncology Center of Excellence (OCE). Rumors indicate that the next director of the Center for Drug Evaluation and Research will be filled soon as the acting director, Jaqueline Corrigan-Curay, has recently departed.  
  • Vinayak Prasad, MD, newly hired director of the Center for Biologics Evaluation and Research, now holds two additional roles as chief medical officer and chief scientific officer. Traditionally two separate roles, this elevation further solidifies Prasad’s position as a senior advisor to Commissioner Marty Makary, MD, and gives him purview to weigh in on regulatory issues outside of CBER.  
  • Makary and Prasad published a Viewpoint article in JAMA titled Priorities for a New FDA, outlining areas they see as critical for additional development at the FDA. These areas included bringing drugs to market faster, integrating AI into drug development and review, increasing regulation on food, making better use of big data, and decreasing drug pricing. 
  • The FDA has greatly increased its communications and outreach efforts since the beginning of the year, with Makary and other high ranking officials releasing podcasts and appearing frequently at events and conferences. For example, the FDA recently held a roundtable on CAR-T cell therapies with academic and industry experts and has been going on a listening tour across the country to hear from pharmaceutical company executives.  
  • The FDA released a new program to speed drug development known as the Commissioner’s National Priority Voucher (CNPV). The voucher, upon redemption, would shorten review processes from the typical 10-12 months following submission of the final drug application to 1-2 months. A limited number of vouchers are to be given by the FDA Commissioner to companies which are aligned with national health priorities, namely by addressing a U.S. health crisis, delivering innovative therapies to Americans, addressing unmet health needs, or increasing domestic manufacturing to improve national security. The voucher can be given for either a specific product or to a company at large, but cannot be transferred or sold, unlike traditional priority review vouchers.  
  • The FDA’s embattled Laboratory Developed Test (LDT) final rule is no more. Issued in May 2024, the rule would have phased in increased oversight of LDTs, requiring them to go through more traditional regulatory pathways, by phasing out FDA’s general enforcement discretion approach to regulation of these devices. This effort to increase regulation was subject to legal challenges on the grounds that the FDA did not have statutory authority to regulate LDTs. On March 31, 2025, the rule was struck down as a result. The FDA had the ability to appeal this decision and continue to pursue regulation for these tests, but the deadline passed on May 30 without an appeal.   

NIH Staff Publish Letter Opposing Policy Changes, Grant Terminations 

-Matt Gontarchick 

Eighty-nine current and former NIH staff joined 253 anonymous colleagues in sending an open letter to NIH Director Jay Bhattacharya to express concerns over actions the administration has taken that they contend has harmed both the agency’s mission and the health of the American people. The letter’s title, the Bethesda Declaration, is both a reference to the NIH headquarters and the Great Barrington Declaration, an open letter Bhattacharya co-signed in 2020 in support of new policies to approach the COVID-19 pandemic. 

In the letter, the 342 signatories expressed appreciation for Bhattacharya’s commitment to academic freedom. They went on to contend that the declaration and its message aligns with Bhattacharya’s recent comments on academic freedom, scientific dissent, and freedom of speech. 

The signatories urged Bhattacharya to take the following actions: 

  1. Restore grants paused or canceled for political reasons.  
  1. Allow the NIH to resume collaboration with vetted foreign entities on rigorously peer-reviewed research. 
  1. Restore independent peer review, the foundation of NIH science. 
  1. Disregard the administration’s proposal to cap indirect costs at 15% and ensure that indirect costs adequately cover grantees’ research costs. 
  1. Reinstate former NIH staff essential to the agency’s work who were subjected to probationary termination, the administration’s reduction in force, or pressure to resign. 

Issued on June 9, the letter was also addressed to Health and Human Services Secretary Robert F. Kennedy, Jr., and members of Congress who serve on committees that have jurisdiction over the NIH. Shortly following the declaration’s release, Democratic leaders of the House Energy and Commerce Committee sent a letter to Kennedy and Bhattacharya urging them not to take retaliatory measures against the Bethesda Declaration’s 342 signatories.  

The AACR remains deeply concerned with the administration’s actions affecting the NIH and the crucial, lifesaving work that researchers undertake. At this critical time, the AACR urges lawmakers to restore stability to NIH and reaffirm bipartisan support for medical research. 

Bipartisan Knock Out Cancer Act Aims to Transform Cancer Research Landscape 

-Blake William Rostine

Representative Brian Fitzpatrick (R-PA) and Representative Debbie Dingell (D-MI) have introduced the Knock Out (K.O.) Cancer Act of 2025 into the 119th Congress. This bipartisan legislation is an essential step forward in proposed cancer research funding increases, as well as plans to address the national cancer drug shortage.  

The Knock Out Cancer Act of 2025 would allocate a 25% funding increase for the National Cancer Institute (NCI) each year for the next five years (based on FY 2022 funding levels). Additionally, it would require the Department of Health and Human Services to look into the causes of the ongoing cancer drug shortages and outline potential ways to improve access to these lifesaving treatments.

“We have made extraordinary strides against cancer in recent decades, thanks in large part to robust, sustained federal investments in medical research,” said Margaret Foti, PhD, MD (hc), chief executive officer of the AACR. “We are grateful to Representatives Fitzpatrick, Dingell, and other leaders in Congress for their ongoing support of NIH and NCI. This bill would help us maintain momentum against this dreadful disease for the benefit of all patients.” 

FDA Oncology Center of Excellence Releases Annual Retrospective Report for 2024 

-Brad Davidson, PhD 

The FDA Oncology Center of Excellence (OCE) recently released its annual report for 2024, presenting a retrospective on another landmark year. OCE reported the approval of a total of 49 new oncology drugs and biologics, including 18 new medical entities or new biological license applications and eight new treatments for pediatric cancers.  

Highlights included Project Orbis, the FDA’s program for international collaboration, reaching its fifth year and contributing to nearly half of all product approvals; continued forward motion on integrating patient reported outcomes (PROs) into drug development through the Patient-Focused Drug Development Program; Project Facilitate’s processing of 761 single-patient expanded access applications that allow patients to receive investigational therapeutics when no other options remain; and the education of over 250 trainees through various educational and fellowship programs. For more details, see the report. 

Register Now: 13th Annual Rally for Medical Research 

The 13th Annual Rally for Medical Research will be held September 17-18, 2025, 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 National Institutes of Health 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 40% cut to the NIH budget.  

Both a participant training and a reception for advocates will be held on September 17, followed by the Rally Hill Day on September 18, 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. 

Registration Open for the AACR Patient Advocate Forum: From Discovery to Survivorship: Technology’s Role in Beating Cancer 

Join advocates and researchers from around the world on Tuesday, July 15, from 1-2:30 p.m. ET, for the virtual American Association for Cancer Research (AACR) Patient Advocate Forum: From Discovery to Survivorship: Technology’s Role in Beating Cancer. The forum will be moderated by AACR SSP Founder Dr. Anna Barker from the Ellison Medical Institute, and will feature presentations by Garry Nolan from Stanford University, Reva Basho from Ellison Medical Institute, Angela M. Belcher from MIT, and Cheryl L. Willman from Mayo Clinic. 

The upcoming forum will explore how advanced technologies are transforming cancer care, with a focused lens on immunotherapy, precision oncology, imaging, and survivorship. Building on the February 2023 Forum, The Impact of Advanced Technologies on Cancer Research, this session will highlight how innovations in these areas are driving unprecedented progress in understanding, diagnosing, and treating cancer.  

Advocates will hear from experts on how cutting-edge tools are revealing new biological insights and enabling more personalized, effective interventions. The forum will also emphasize how these technologies are shaping the patient experience across the continuum of care—from diagnosis through survivorship. 

The AACR offers this educational program to all members of the patient advocate and research community at no cost. A recording will be available for those unable to attend; please register below to access it.

Register online. 

Application 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 2026, taking place in San Diego, California, from April 17-22. 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 the 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. 

Oncology Approval Recap 

-Brad Davidson, PhD 

Between May 23 and June 26, the U.S. Food and Drug Administration granted six new oncology drug approvals, including one accelerated approval and five traditional approvals.  

  • Datopotamab deruxtecan-dlnk received accelerated approval for adults with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. This application received priority review and the breakthrough therapy designation.  
  • Tafasitamab-cxix was approved in combination with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma. This is the first traditional approval for this product. This application received priority review, and review was conducted under the FDA’s Project Orbis framework for concurrent review of oncology drug products among international partners, including the Australian Therapeutic Goods Administration (TGA) and Health Canada (HC).
  • Pembrolizumab was approved for the treatment of adults with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 as a single agent in the neoadjuvant setting with continued treatment in combination with radiotherapy and with or without cisplatin in the adjuvant setting. This is pembrolizumab’s 41st indication, the first overall approval in HNSCC in six years, and the first ever perioperative approval for HNSCC. This application received priority review, and was reviewed under the FDA’s Project Orbis with international review partners including the TGA, HC, the Brazilian Health Regulatory Agency, and Switzerland’s Swissmedic. 
  • Taletrectinib was approved for the treatment of adults with locally advanced or metastatic ROS-1 positive NSCLC. This is the first approval for this product, a next-generation oral ROS1 tyrosine kinase inhibitor. This application was granted priority review, breakthrough designation, and orphan drug designation.  
  • Darolutamide was approved as a single agent for metastatic castration-sensitive prostate cancer (mCSPC). Darolutamide was previously approved in 2022 in combination with docetaxel in this setting, now allowing for treatment with or without chemotherapy. This review was conducted under the FDA’s Proiect Orbis with international review partners including the TGA, HC, Switzerland’s Swissmedic, and the United Kingdom’s Medicine and Healthcare Products Regulatory Agency.