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Latest Stories
Health and Human Services Secretary Robert F. Kennedy Jr. is moving to overhaul the U.S. Preventive Services Task Force, a highly influential panel that determines which preventive services insurers must cover and guides routine medical care for millions of Americans.
Regulatory News
Disappointment hangs in the air as Replimune’s Biologics License Application for RP1 (vusolimogene oderparepvec) in combination with nivolumab in the treatment of advanced melanoma was denied again by FDA on April 10.
The National Academy of Sciences has announced the election of 120 members and 25 international members.
Cancer Policy
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, or ACIP, voted in December to rescind its recommendation that all newborns receive a hepatitis B virus vaccine dose within 24 hours of birth.
Cancer Policy
Radiation oncologists are warning lawmakers that recent Medicare policy changes threaten the viability of community cancer clinics.
In Brief
The University of Texas MD Anderson Cancer Center announced a $10 million gift from Peggy and Carl Sewell to establish the Center for Cellular Language Intelligence, a research center created to understand the behavior of cancer cells at a high resolution, potentially enabling earlier cancer detection, smarter prevention, and more precise, personalized treatments.
In Brief
Varian, the Siemens Healthineers business area, has been awarded up to $60 million over five years by the U.S. Advanced Research Projects Agency for Health to accelerate development of photon Flash therapy, an ultra-high dose rate approach to radiotherapy with the potential to redefine cancer care.
In Brief
The University of Texas at San Antonio has been awarded a five-year, $44 million contract from the National Heart, Lung, and Blood Institute for a study focused on persistent health challenges in the rural South.
In Brief
The International Agency for Research on Cancer has published a landmark issue of the Journal of the National Cancer Institute Monographs to mark the Agency’s 60th anniversary.
In Brief
Frederick J. Meyers received two prestigious honors from the Association for Clinical and Translational Science.
Clinical Roundup
A Mayo Clinic has developed an artificial intelligence model that can help specialists detect pancreatic cancer on routine abdominal CT scans up to three years before clinical diagnosis. It identifies subtle signs of disease before tumors are visible, when curative treatment may still be possible.
Clinical Roundup
Scientists at The Wistar Institute and clinical researchers from ChristianaCare’s Helen F. Graham Cancer Center & Research Institute have discovered a vulnerability in pancreatic cancer that could be targeted as a potential therapy.
Clinical Roundup
Diaceutics has released research revealing a critical shift in precision medicine. Despite major advances in biomarker testing, nearly two-thirds of eligible patients with advanced non-small cell lung cancer in the U.S. are still not receiving the most appropriate treatment.
Clinical Roundup
Early exposure to PFAS, a group of widely used compounds known as “forever chemicals,” was associated with a higher risk of acute lymphoblastic leukemia, the most common childhood cancer, according to researchers at the University of California, Irvine Joe C. Wen School of Population & Public Health.
Clinical Roundup
Eating creates a temporary metabolic state that influences the function of T cells, according to researchers at the University of Pittsburgh.
Drugs & Targets
The FDA Oncologic Drugs Advisory Committee on April 30 considered two applications from AstraZeneca Pharmaceuticals LP.
Drugs & Targets
FDA has accepted a New Drug Application for zipalertinib for the treatment of patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy, with or without amivantamab. The Prescription Drug User Fee Act target action date is Feb. 27, 2027.
Drugs & Targets
FDA has accepted for filing with Priority Review the supplemental Biologics License Application for Ziihera (zanidatamab-hrii) containing combinations for the first-line treatment of adult patients with HER2-positive unresectable locally advanced or metastatic gastric, gastroesophageal junction, or gastroesophageal adenocarcinoma.
Drugs & Targets
FDA has approved an Investigational Device Exemption supplement to its U.S. multi-center pancreatic cancer pilot study, known as IMPACT (Intratumoral Pancreatic Alpha Combination Trial), evaluating the safety, feasibility, and efficacy of Alpha DaRT in combination with chemotherapy for patients with newly diagnosed unresectable locally advanced or metastatic pancreatic adenocarcinoma.
Drugs & Targets
Unfold AI, an AI prostate cancer mapping and clinical decision support platform, is now included in Medicare’s Physician Fee Schedules across the West Coast and Mountain West regions. The regional expansion of Medicare payment for the tool gives urologists and care teams clearer reimbursement pathways in physician office settings, an area that has historically lagged behind hospital outpatient settings for emerging technologies.
NCI Trials
The National Cancer Institute approved the following clinical research studies last month.
Podcast
The intersection of art and education is well established, but its application in oncology remains limited.
The Directors
In recent months, several directors of cancer centers, appearing on The Directors, a segment of The Cancer Letter Podcast, mentioned that their institutions are increasingly providing small grants—typically in the range of $50,000—to scientists to enable them to keep their labs open.
NCI
Tucked in at the end of a 20-minute talk that covered paylines, promising young investigators, and precision medicine, NCI Director Anthony G. Letai beefed up the alliteration with two more words that begin with a “p”: prevention and pilot.
Clinical
In theory, cervical cancer could be almost entirely eliminated with prevention and screening efforts, thanks to a quirk of the disease’s histology: Virtually all cases are caused by high-risk human papillomavirus, for which there is both a vaccine and an effective screening test.
Guest Editorial
Cancer survivorship in the United States now tops 18 million people. That is a lot of people walking around with a shared experience, and yet somehow we barely talk about what surviving cancer actually does to you.
Guest Editorial
On April 28, 1986, when a radioactive plume reached Sweden, the world discovered that there had been a huge accident at the Chernobyl nuclear power facility in Ukraine. The accident had occurred two days earlier, and the details were hidden by Soviet authorities.
Cancer Policy
At the Senate Finance Committee hearing on April 22, Health and Human Services Secretary Robert F. Kennedy Jr. hinted at how he intends to reform the U.S. Preventive Services Task Force, a highly respected, independent organization that weighs evidence to make recommendations on screening for diseases.
Cancer Policy
HHS Secretary Robert F. Kennedy Jr. testified before two Senate committees on April 22 as part of a final “blitz” of congressional budget hearings.
Cancer Policy
President Trump has nominated Erica Schwartz, who served as deputy surgeon general in his first administration, to serve as the next director of the Centers for Disease Control and Prevention.
Cancer Policy
FDA announced that it has achieved its first-year goals in implementing its roadmap to reduce animal testing in preclinical studies.
Cancer Policy
The Centers for Medicare and Medicaid Services and FDA announced a new coverage pathway—called the Regulatory Alignment for Predictable and Immediate Device, or RAPID pathway—designed to expedite access to certain FDA-designated Class II and Class III Breakthrough devices for people with Medicare.
In Brief
The University of Texas at Austin is building an integrated academic medical center from the ground up, where care, research, and education operate as one system organized around the patient. This model connects prevention, diagnosis, treatment, and long-term health into a continuous experience, particularly for those with complex and serious conditions.
In Brief
The Keck School of Medicine of USC and Keck Medicine of USC announced collaborations with Tempus AI Inc. to integrate clinical care, clinical trials, and research through a unified framework.
In Brief
Sandeep Raj, Lars Velten, Satoshi Kaito, and Zhenyu Dai were awarded DKMS John Hansen Research Grant.
In Brief
Quest Diagnostics, a provider of diagnostic information services, announced that City of Hope is implementing Haystack MRD, a circulating-tumor DNA minimal residual disease test, for clinical trial participants with solid tumor cancers to help guide disease management for patients being treated for breast, colorectal, ovarian, and prostate cancer.
In Brief
Lisa Eli has been appointed chief scientific officer at Zephyr AI Inc.
In Brief
The 14th annual Chuckstrong Tailgate Gala raised more than $900,000 for research at the Indiana University Melvin and Bren Simon Comprehensive Cancer Center.
In Brief
The Association of Health Care Journalists announced Claire Marie Porter, reporter at The Cancer Letter, as the 1st place winner of the 2025 Awards for Excellence in Health Care Journalism in the Trade (All Sizes) category.
Clinical Roundup
In the phase II CAR-PRISM (PRecision Intervention Smoldering Myeloma) clinical trial, the first to investigate CAR T-cell therapy in patients with high-risk smoldering multiple myeloma, all 20 patients were negative for minimal residual disease within two months of treatment and remained MRD-negative after a median of 15.3 months of follow-up.
Clinical Roundup
A multicenter research team led by Johns Hopkins Medicine have identified a protein called claudin-4 that binds to the B. fragilis toxin receptor, a toxin which is known to drive colon tumor formation.
Drugs & Targets
FDA granted Fast Track designation to Debiopharm for the use of its PKMYT1 inhibitor, lunresertib (Debio2513), and its WEE1 inhibitor, zedoresertib (Debio 0123) for the treatment of adult patients with CCNE1 amplified, or a deleterious mutation in either FBXW7 or PPP2R1A, platinum-resistant/refractory ovarian cancer.
Drugs & Targets
The European Commission has granted conditional marketing authorization for Ojemda (tovorafenib) as monotherapy for the treatment of patients 6 months of age and older with pediatric low-grade-glioma harboring a BRAF fusion or rearrangement, or BRAF V600 mutation, who have progressed after one or more prior systemic therapies.
Podcast
FDA has cleared the first at-home self-collection kit for HPV screening, removing significant obstacles to cervical cancer detection.
Regulatory News
Boca Raton resident Gabriela Sanchez recently found herself stepping into a mobile outreach vehicle operated by Sylvester Comprehensive Cancer Center.
Clinical
The long-awaited results from the RASolute 302 trial—a phase III clinical trial evaluating daraxonrasib, a RAS inhibitor, for the treatment of patients with previously treated, metastatic pancreatic ductal adenocarcinoma—have been read out.
Editorial
At a lecture at Yale Cancer Center recently, Robert A. Winn brandished a copy of a 32-year old booklet titled “Cancer at a Crossroads: A Report to Congress for the Nation,” using it as a show-and-tell prop in arguing that America’s cancer program is once again at a crossroads and therefore in urgent need of strategic thinking (The Cancer Letter, April 10, 2026).
Guest Editorial
China’s biotech sector is rapidly becoming a global innovation powerhouse. In oncology alone, Chinese licensing deals reached $30 billion in 2024—triple the United States’ output. Nearly a third of the world’s clinical trials now take place in China.
Sponsored
The era of genomic oncology is defined by complexity. Over the last decades, we have moved from single-gene tests to multi-gene panels and, eventually, will be routinely using whole-exome/whole-genome and transcriptome sequencing in clinical care.
Cancer Policy
FDA has added stereotactic breast biopsy needles to its Medical Device Shortages List with an estimated duration of “through Q4 2026,” which spans July 1 to Sept. 30.
Cancer Policy
The Centers for Medicare & Medicaid Services issued the 2026 CMS Interoperability Standards and Prior Authorization for Drugs proposed rule, which aims to shorten care delays and improve transparency within federal health insurance programs by establishing electronic prior authorization, or ePA, requirements for covered prescription drugs and expedite federal response deadlines to ensure patients receive life-critical medications without administrative delay.
Cancer Policy
A meeting convened by Friends of Cancer Research focused on the methodology for using external control arms in cancer clinical trials.
Cancer Policy
The Advisory Committee on Immunization Practices, or ACIP, renewed its charter April 6. In an announcement in the Federal Register, new criteria for ACIP members were rolled out with a focus on “geographical balance” and a “balance of speciality areas.”
Cancer Policy
FDA issued a stern reminder to medical product companies and researchers of the requirements to submit certain clinical trial results information to ClinicalTrials.gov.
Cancer Policy
A coalition of public health groups sent a formal letter to NIH Director and Acting CDC Director Jay Bhattacharya April 15 highlighting the need for the immediate restoration of full staffing and resources to the CDC’s Office on Smoking and Health.
In Brief
The Cancer Center at Illinois was designated as a Basic Cancer Center by NCI.
In Brief
The American Association for Cancer Research will honor leaders from government and the advocacy community with awards for distinguished service in support of cancer research at the AACR Annual Meeting 2026 to be held April 17-22 in San Diego.
In Brief
The START Center for Cancer Research, a community-based network of clinical trial sites specializing in early-phase oncology trials, announced the appointment of Salwan Al Mutar as director of Clinical Research at START Dallas-Fort Worth.
In Brief
Miguel Materin, an ophthalmologist, oncologist, and researcher of rare and complex eye cancers, was named head of ocular oncology at the Northwell Cancer Institute.
In Brief
Takeda and Nature announced the grand prize winner for the 2026 Innovators in Science Award—Myriam Chalabi, a medical oncologist at the Netherlands Cancer Institute.
In Brief
The Parker Institute for Cancer Immunotherapy announced a strategic integration with the Cancer Vaccine Coalition, a nonprofit dedicated to advancing next-generation cancer immunotherapies, to accelerate the development and delivery of cancer vaccines, one of the most promising frontiers in cancer research.
In Brief
Christian Hinrichs, co-director of the Duncan and Nancy MacMillan Cancer Immunology and Metabolism Center of Excellence and chief of the Section of Cancer Immunotherapy, RWJBarnabas Health, has been awarded a four-year, $800,000 translational research grant from the V Foundation for Cancer Research to develop next-generation immunotherapies for cancers caused by human papillomavirus.
In Brief
Brandeis University has announced that Sheila Efron Taube ’63, a pioneer in cancer research, will receive the Alumni Achievement Award for outstanding contributions to their fields and society.
In Brief
Sylvester Comprehensive Cancer Center, part of the University of Miami Miller School of Medicine, has developed a cloud-based informatics platform that combines clinical and genomic data from multiple sources into one unified platform.
In Brief
The Skin Cancer Foundation is bringing Destination Healthy Skin to 40 cities in 22 states this year. The Foundation kicked off its 2026 mobile education and screening program on April 15 in Columbus, Ohio.
In Brief
The Marlene and Stewart Greenebaum Family Foundation has donated $5.5 million to the University of Maryland Greenebaum Comprehensive Cancer Center to help advance scientific research and cancer care in Maryland and across the region.
Clinical Roundup
Patients with stage 3 colon cancer with deficient DNA mismatch repair had significantly better outcomes when the immunotherapy drug atezolizumab (Tecentriq) was added to standard chemotherapy after surgery, according to a study by researchers at the Alliance for Clinical Trials in Oncology.
Clinical Roundup
Patients with pancreatic cancer who received the experimental drug elraglusib, alongside standard chemotherapy, were twice as likely to be alive after one year of treatment, compared to those receiving chemotherapy alone, according to the results of a randomized phase II clinical trial conducted by researchers at Northwestern University. The drug also reduced the risk of death by 38%.
Clinical Roundup
UPMC and University of Pittsburgh clinician-scientists have weaned and kept multiple liver transplantation patients off of all immunosuppressant drugs for more than three years through a first-in-human clinical trial of a unique “immune priming” therapy, according to the results of a small, early-stage trial.
Clinical Roundup
A novel transdermal therapy designed to modulate tumor pH called DYV800 helped make tumors substantially less acidic, restore T-cell activity, slow tumor growth, and improve survival in preclinical studies, according to a study using animal models of bladder cancer conducted by Dyve Biosciences, in collaboration with Moffitt Cancer Center.
Clinical Roundup
For years, a central debate in tobacco policy has been whether taxing e-cigarettes might unintentionally drive vapers back to traditional cigarettes.
Clinical Roundup
The Alliance for Clinical Trials in Oncology is enrolling patients into a clinical trial aimed at helping women recover from the vaginal side effects of breast cancer treatment.
Drugs & Targets
FDA issued a draft guidance for sponsors seeking approval of human gene therapy products involving genome editing technologies. When finalized, this guidance will provide recommendations for standardized methods for comprehensively assessing the safety of genome editing therapies to bring effective treatments to patients sooner.
Podcast
The Cancer Letter’s most recent cover story featured an in-depth Q&A with Anthony G Letai, director of the National Cancer Institute.
Conversation with The Cancer Letter
Over the course of his first six months as NCI director, Anthony Letai has contended with federal budget turbulence, a record-setting government shutdown, and concerns about the flow of over research dollars.
Guest Editorial
Recently, a friend lent me a copy of a decades-old report, and by old, I mean a classic.
The California Institute for Regenerative Medicine, a state agency tasked with awarding billions of dollars of scientific funding for stem cell and gene therapy, has rescinded a controversial policy that was disrupting the flow of funding to cancer research.
Trials & Tribulations
Radiation therapy has been a cornerstone of cancer care since 1896. For more than a century, the central challenge has remained unchanged: How to eradicate tumors while preserving the normal tissues that allow patients not only to survive, but to thrive after treatment.
Cancer Policy
President’s budget request would cap indirect costs and fully fund all NIH research projects upfront
NCI has emerged relatively unscathed in the president’s FY 2027 budget request that would slash $15.8 billion from HHS funding, cut NIH overall by about 10%, eliminate three NIH institutes and centers, and move the Institute for Environmental Health Sciences and its circa $1 billion budget out of NIH.
Cancer Policy
The Centers for Medicare & Medicaid Services has proposed a rule to update Medicare payments for hospice care in the next fiscal year, which begins on Oct. 1.
In Brief
The American Association for Cancer Research will honor the following cancer researchers and physician-scientists during the 2026 AACR annual meeting April 17-22 in San Diego.
In Brief
Ulrich G. Steidl was named director of the Montefiore Einstein Comprehensive Cancer Center and vice president of cancer medicine at Montefiore Einstein. He has acted as interim director of MECCC, an NCI-designated Comprehensive Cancer Center, since late 2025.
In Brief
Christian Capitini, an expert in the treatment and research of childhood cancers, was named director of the University of Wisconsin Carbone Cancer Center. Capitini has served as acting director of the cancer center since December 2024.
In Brief
Wafik S. El-Deiry is stepping down as director of the Legorreta Cancer Center at Brown University and as associate dean of oncologic sciences in the Division of Biology and Medicine, effective June 30. He was appointed founding director of the Cancer Center at Brown University in 2019.
In Brief
Nancy L. Lewis was named chief scientific officer of the National Comprehensive Cancer Network. Lewis will assume the role in May.
In Brief
The National Comprehensive Cancer Network named the members of its inaugural cohort of fellows of the Advocacy Academy. The NCCN Advocacy Academy is a program launched in 2026 to ensure that voices of oncology professionals are present at the health policy decision-making table.
In Brief
Russ Paulsen was named the president and CEO of Research!America, a nonprofit alliance that advocates for science, discovery, and innovation.
In Brief
Christian “Chris” Nelson, a clinical psychologist, was named the director of the Walther Center for Supportive Oncology at the Indiana University Melvin and Bren Simon Comprehensive Cancer Center, effective April 1.
In Brief
The VCU Massey Comprehensive Cancer Center completed the inaugural funding cycle of its VCU–Sanford Burnham Prebys Drug Discovery Collaborative Program, a collaboration with the Sanford Burnham Prebys Medical Discovery Institute in La Jolla, CA.
Clinical Roundup
Cancer AI Alliance announced its first wave of eight pilot projects across a federated learning platform. These projects represent the first wave of the organization’s efforts and aim to demonstrate that it is possible to analyze vast amounts of data while keeping patient privacy secure at the local level.
Clinical Roundup
Adults aged 80 and older with early-stage lung cancer can safely undergo surgery and achieve outcomes comparable to younger patients, challenging longstanding assumptions about age and cancer treatment, according to a study led by researchers at the Icahn School of Medicine at Mount Sinai and the Mount Sinai Tisch Cancer Center.
Clinical Roundup
A randomized trial conducted by the Alliance for Clinical Trials in Oncology with support from NCI has found that duloxetine, a medication commonly used to treat chronic pain and psychiatric conditions, does not prevent nerve damage caused by chemotherapy in patients with colorectal cancer.
Drugs & Targets
FDA cleared Onclarity HPV Self-Collection Kit and approved the BD Onclarity HPV Assay with extended genotyping for at-home use, marking a significant milestone in expanding access to cervical cancer screening and removing barriers that currently prevent many individuals from receiving routine screening.
Drugs & Targets
Nuvalent announced the submission of a New Drug Application to FDA for neladalkib, an investigational ALK-selective inhibitor, in TKI pre-treated advanced ALK-positive non-small cell lung cancer.
Podcast
The new 2025-2030 Dietary Guidelines for Americans, or DGA, which inform federal nutrition policies, school meals, and public health education were announced by Health Secretary Robert F. Kennedy Jr. earlier this year.
News Analysis
Recently, HHS Secretary Robert F. Kennedy Jr. posted a video montage featuring himself shirtless in jeans, working out with Kid Rock. The duo is in a blue-lit grotto with a cold plunge and sauna. Set to Kid Rock’s “Bawitdaba” and intercut with a selection of patriotic imagery, the video ends with the two men in a hot tub, chugging what appears to be milk.
Free
It took Yuliia Lozko nearly three days to travel to Sidney Kimmel Comprehensive Cancer Center at Jefferson Health in Philadelphia.
Guest Editorial
In January, FDA released a draft guidance entitled “Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints to Support Accelerated Approval.” This release came roughly 20 months after the Oncologic Drugs Advisory Committee (ODAC) voted unanimously that minimal residual disease (MRD) negativity, in combination with complete response (CR), is an acceptable primary endpoint to support accelerated approval for multiple myeloma (MM) therapies.
Editorial
We have good news: The Cancer Letter Podcast is a nominee for The Webby Awards, which are recognized as the internet’s highest honor.
Cancer Policy
Budgets can surprise you, and the White House budget proposal for fiscal year 2027 is more surprising than most.
