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Latest Stories
Podcast
FDA’s Center for Biologics Evaluation and Research Director Vinay Prasad is set to leave the agency for a second time amid controversy.
Conversation with The Cancer Letter
Five years ago, Tyler Jacks took on a new challenge, becoming president of Break Through Cancer, a foundation that has pledged to spend at least $500 million to support research projects across top tier cancer centers.
Regulatory News
Amid deepening controversy, Vinay Prasad, FDA’s top clinician and scientist, and director of its Center for Biologics Evaluation and Research, will be leaving the agency.
Regulatory News
On Jan. 9, Pierre Fabre Pharmaceuticals received a “complete response letter” from FDA: its application for the T-cell therapy tabelecleucel (Ebvallo) was getting a hard No.
Guest Editorial
The cancer research community has a reason to celebrate. For the first time, 70% of people are living at least five years beyond their cancer diagnosis. And, as importantly, cancer death rates have been dropping relentlessly—by more than a third since 1991.
Free
Poisoning one’s political rivals has a long history. In 399 B.C., an Athenian court found Socrates guilty of “impiety and the corruption of youth” and ordered him to drink a fatal dose of hemlock.
Cancer Policy
Yet another U.S. Preventative Services Task Force meeting is postponed—the third missed meeting since the start of the second Trump administration.
Cancer Policy
FDA has approved leucovorin calcium tablets (Wellcovorin), expanding its use for the treatment of cerebral folate deficiency in adult and pediatric patients.
In Brief
The Pezcoller Foundation American Association for Cancer Research International Award for Extraordinary Achievement in Cancer Research will be presented to Douglas R. Lowy and John T. Schiller, both fellows of the AACR Academy, during the AACR Annual Meeting 2026.
In Brief
Vivek Subbiah has been appointed as the inaugural associate director for drug development and precision oncology at the Stanford Cancer Institute, with a planned start date in spring 2026.
In Brief
Lonny Yarmus was appointed head of the Division of Subspecialty Medicine in the Department of Medicine at Memorial Sloan Kettering Cancer Center. A physician-scientist and internationally recognized leader in interventional pulmonology and procedural innovation, Yarmus is widely known for his expertise in minimally invasive diagnostics and therapeutics, outcomes research, and multidisciplinary program development.
In Brief
Mass General Brigham has received a $50 million gift for gene and cell therapy research. The gift, made by anonymous donors, will advance clinical research by experts at Mass General Brigham Cancer Institute and throughout the system, to deliver treatments for patients with cancer and other diseases.
In Brief
GRAIL has announced that Bob Ragusa will retire as CEO, effective June 1.
In Brief
The multinational Hepatitis B and HIV Cure Consortium, colloquially known as the BICC, was recently established through the awarding of a five-year, $24 million grant from NIH’s National Institute of Allergy and Infectious Diseases.
In Brief
The University of Illinois Cancer Center has awarded two 2026 Pilot Project Program Awards to pairs of Cancer Center members: Bin He and VK Gadi; and Ece Mutlu and Constance Jeffery.
In Brief
The Advanced Research Projects Agency for Health, an agency within HHS, announced the launch of its Delphi program, an initiative to advance low-cost biosensors that can monitor hormones, inflammatory markers, and other important biochemical signals.
Clinical Roundup
Follicular lymphoma, a common and usually slow-growing type of non-Hodgkin lymphoma, has long been deemed incurable: Though the disease responds well to initial treatment, oncologists tell patients to expect it to come back. The results from a 15-year follow-up analysis of clinical trial patients with follicular lymphoma could upend that prediction.
Clinical Roundup
The phase III persevERA Breast Cancer study, evaluating investigational giredestrant in combination with palbociclib for people with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, did not meet its primary objective of a statistically significant improvement in progression-free survival in the intent-to-treat population versus letrozole plus palbociclib, but a numerical improvement was observed.
Clinical Roundup
Oral mezigdomide in combination with carfilzomib and dexamethasone demonstrated statistically significant and clinically meaningful improvement in progression-free survival versus carfilzomib and dexamethasone alone in patients with relapsed or refractory multiple myeloma, according to positive interim phase III results from the SUCCESSOR-2 study.
Clinical Roundup
A team of researchers at VCU Massey Comprehensive Cancer Center has identified a new pathway through which mutations in the tumor suppressor p53 gene—found very frequently in human tumors—hijack DNA replication in cancer cells.
Clinical Roundup
Johns Hopkins Medicine scientists say they have developed a simplified version of biodegradable nanoparticles that can “educate” the immune system to find and destroy disease-causing cells throughout the body.
Clinical Roundup
Medically supervised, individualized nutrition therapy—long proven effective in reversing metabolic diseases like type 2 diabetes and obesity—shows promise in extending survival in patients with metastatic pancreatic cancer when used alongside chemotherapy, according to data from a randomized, controlled phase II clinical trial.
Clinical Roundup
New research from a University of Cincinnati Cancer Center study found external beam radiation therapy is safe to administer to patients with liver cancer even after they undergo a targeted internal radiation therapy called Y90.
Clinical Roundup
Citius Oncology announced positive topline safety and efficacy results from an investigator‑initiated phase I trial evaluating Lymphir (E7777, denileukin diftitox‑cxdl) administered prior to commercial CD19‑directed CAR T therapy in patients with high‑risk relapsed or refractory diffuse large B‑cell lymphoma.
Clinical Roundup
Citius Oncology announced positive topline results from a completed investigator‑initiated phase I clinical trial conducted by University of Pittsburgh investigators. This study evaluated the direct T-regulatory cell depletion activity of Lymphir (denileukin diftitox‑cxdl) in combination with the PD-1 immune checkpoint inhibitor pembrolizumab (Keytruda) in patients with recurrent or refractory gynecologic cancers, including ovarian and endometrial malignancies.
Clinical Roundup
Fred Hutch Cancer Center scientists reached a crucial milestone in blocking Epstein-Barr virus, a pathogen estimated to infect 95% of the global population that is linked to multiple types of cancer, neurodegenerative diseases and other chronic health conditions.
Clinical Roundup
A growing number of U.S. adults consider electronic cigarettes (e-cigarettes) more harmful than conventional cigarettes, UT Southwestern Medical Center researchers show in a study.
Drugs & Targets
FDA has approved Tecvayli (teclistamab-cqyv) plus Darzalez Faspro (daratumumab and hyaluronidase-fihj) for the treatment of adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent.
Drugs & Targets
Ipsen announced that it is voluntarily withdrawing Tazverik (tazemetostat) in all indications from all Ipsen markets. Ipsen’s decision to withdraw is based on emerging data from the ongoing phase Ib/III SYMPHONY-1 trial (evaluating tazemetostat in combination with lenalidomide plus rituximab vs R2 in follicular lymphoma).
Podcast
One result, two reactions: GRAIL’s Hall and NCI’s Castle react to negative NHS-Galleri trial outcome
On Feb. 19, GRAIL Inc. announced that its pivotal NHS-Galleri trial failed to meet its primary endpoint of reduction in advanced stage cancers. The media and the market reacted as one would expect: GRAIL’s stock price halved the day after the announcement and at least three law firms said that they are conducting investigations in preparation for filing investor suits.
News Analysis
If you listen to GRAIL executives discuss the results of the long-awaited trial of the company’s multicancer detection test, you might be led to conclude that the company’s pivotal NHS-Galleri study had an overwhelmingly positive result.
Conversation with The Cancer Letter
Undeterred by the negative topline result of its pivotal trial of Galleri, a multicancer detection test, the test’s sponsor, GRAIL, said it’s forging ahead with its plan to get FDA approval and reimbursement from CMS and private insurers.
Conversation with The Cancer Letter
Philip E. Castle, director of the NCI Division of Cancer Prevention, said he was disappointed to hear that GRAIL’s NHS-Galleri trial did not meet its primary endpoint of reduction in late-stage cancers.
Obituary
Erin Geddis Cummings , advocate and founder of Hodgkin’s International, died on Feb. 24, at Martha’s Vineyard Hospital, surrounded by her family. She was 68.
Sponsored
Vasan Yegnasubramanian, MD, PhD, is the director of Precision inHealth Medicine at Johns Hopkins. He spoke with Johns Hopkins Kimmel Cancer Center communications staff about how AI is transforming cancer research and treatment. The transcript of the conversation follows.
Cancer Policy
Mount Sinai hospital has formed a committee to investigate the ties between Jeffrey Epstein and Eva Dubin a Swedish physician and philanthropist who founded the Dubin Breast Center at the Tisch Cancer Institute whose name is featured prominently in the Epstein files.
Cancer Policy
Rep. Josh Gottheimer (D-NJ) introduced the FIRE Cancer Act on Feb. 27. The piece of legislation seeks to increase grant dollars available to local fire departments, specifically earmarked for cancer prevention, “including providing multi-cancer early detection testing or other forms of preventative tests.”
In Brief
W. Kimryn Rathmell, CEO of the James Cancer Hospital and Solove Research Institute, has also been named director of The Ohio State University Comprehensive Cancer Center in place of former Director Raphael E. Pollock, who has stepped down from the position he had held since November 2017 to become OSUCCC director emeritus.
In Brief
Bob Gray has retired from his role as Group Statistician, Therapeutics, for the ECOG-ACRIN Cancer Research Group, as of Feb. 28.
In Brief
Eric Gardner, Betty Kim, Rodrigo Romero, and Hojong Yoon were appointed members of the James P. Allison Institute at The University of Texas MD Anderson Cancer Center.
In Brief
Fred Hutch Cancer Center announced the recipients of the Harold M. Weintraub Graduate Student Award, which honors the exceptional achievements of graduate students in the biological sciences.
In Brief
M. Saiful Huq, director of medical physics in the Department of Radiation Oncology at the University of Pittsburgh and UPMC Hillman Cancer Center, has been awarded the Inaugural Gold Medal of the Asia and Middle East Society of Therapeutic Radiation and Oncology.
In Brief
Cancer Grand Challenges awards five global teams of scientists up to $25 million each to take on questions that could open entirely new routes for cancer prevention, detection, and treatment.
In Brief
Penn Medicine received a $10 million gift from Cynthia King, the late Jeffery King, and Jason and Julie Borrelli to establish the King Center for Lynch Syndrome, at the Abramson Cancer Center of the University of Pennsylvania.
In Brief
The University of Hawaiʻi Cancer Center’s Epidemiology Division was the victim of a cyberattack that possibly exposed records containing Social Security numbers and driver’s license numbers, mostly from Hawaiʻi DL records collected in 2000 from the State Department of Transportation (when identifiers were usually SSNs) and City and County of Honolulu voter registration records collected in 1998 (also when identifiers were usually SSNs).
Clinical Roundup
Colorectal cancer rates in the U.S. are moving in two very different directions, according to a report released from the American Cancer Society.
Clinical Roundup
A study led by UCLA Health Jonsson Comprehensive Cancer Center investigators suggests that adding hormone therapy to post-operative radiotherapy may provide little survival benefit for most men with prostate cancer, especially for those with very low PSA levels before treatment.
Clinical Roundup
Researchers from the Johns Hopkins Kimmel Cancer Center and the Johns Hopkins University have created a novel database structure that allows investigators anywhere to more easily study multiple types of cancer data—including laboratory results, genetic sequencing and imaging data—in one setting.
Clinical Roundup
Researchers at the Johns Hopkins Kimmel Cancer Center report that an artificial intelligence-based liquid biopsy test using genome-wide cell-free DNA fragmentation patterns and repeat landscapes can detect early liver fibrosis and cirrhosis, and may also reveal signals of broader chronic disease burden.
Clinical Roundup
About 50% of triple-negative breast cancer patients develop resistance to therapy. When resistance arises, tumors are more likely to come back after the original treatment, significantly reducing the chances of survival.
Clinical Roundup
A study led by researchers at St. Jude Children’s Research Hospital shows that microbial cell-free DNA sequencing can predict bloodstream infections in children with leukemia days before the infection is apparent.
Clinical Roundup
A study suggests that laser interstitial thermal therapy using NeuroBlate may enhance the effectiveness of the immunotherapy drug pembrolizumab (Keytruda) for patients with recurrent high grade astrocytoma, including glioblastoma.
Drugs & Targets
FDA has approved teclistamab (Tecvayli) in combination with daratumumab hyaluronidase-fihj for adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.
Drugs & Targets
FDA has granted tentative approval for the Abbreviated New Drug Application for Lutetium Lu 177 Dotatate (PNT2003), a radioequivalent version of Lutathera (lutetium Lu 177 dotatate), which is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut, and hindgut neuroendocrine tumors.
Drugs & Targets
Keytruda (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) reduced the risk of event-free survival events by 47% and reduced the risk of death by 35% when given before and after surgery versus neoadjuvant chemotherapy and surgery in patients with muscle-invasive bladder cancer who are eligible for cisplatin-based chemotherapy.
NCI Trials
The National Cancer Institute approved the following clinical research studies last month.
Podcast
Lawsuits brought against Tempus AI raise more questions than answers about DNA privacy in the AI era
Two lawsuits filed within days of each other in the U.S. District Court for the Northern District of Illinois claimed that Tempus AI Inc., an AI-driven precision and genomic testing company, had violated the Illinois Genetic Information Privacy Act when it acquired Ambry Genetics and started to integrate its genetics data into its predictive models.
The Directors
“We’ve always argued that money comes and goes, but if you lose a generation of scientists—you can’t buy them back,” said Kelvin Lee, director of the Indiana University Simon Comprehensive Cancer Center.
Two lawsuits filed within days of each other in the U.S. District Court for the Northern District of Illinois claim that Tempus AI Inc. had violated the Illinois Genetic Information Privacy Act when it acquired Ambry Genetics and started to integrate its genetics data into its predictive models.
Podcast
Joni D. Nelson, assistant director for the Office of Workforce Development at the MUSC Hollings Cancer Center, remembers the exact day a switch went off in her head and her career took a turn towards finding ways to improve public health.
The Stephenson Global Pancreatic Cancer Research Institute, established a little over a year ago with a $150 million gift from entrepreneurs and philanthropists A. Emmet Stephenson Jr. and Tessa Stephenson Brand, has refined its goals.
Guest Editorial
Radiology departments have tried for years to “own” or “fix” clinical trials imaging assessment workflows by extending clinical tools (PACS, worklists, dictation systems) and habits (speed, seamlessness, few clicks) into the research world.
Cancer Policy
Former members of the U.S. Preventative Services Task Force are sounding alarm about an apparent plan by HHS to eliminate the highly respected and influential 16-member expert panel.
Cancer Policy
HHS leadership has announced they will be pursuing steps to “crack down on fraud in Medicare and Medicaid.”
Cancer Policy
FDA issued draft guidance for sponsors seeking full approval for targeted individualized therapies by generating substantial evidence of effectiveness and safety when randomized controlled trials are not feasible due to small patient populations.
In Brief
After more than 18 years leading Georgetown University’s Lombardi Comprehensive Cancer Center, including four consecutive Cancer Center Support Grant renewals, Louis M. Weiner has announced his decision to step down later this year.
In Brief
Neal J. Meropol was named principal investigator of the American Society of Clinical Oncology’s Targeted Agent and Profiling Utilization Registry study.
In Brief
David Weinberg was named vice president/physician lead of Fox Chase Cancer Center’s Cancer Screening and Prevention Service Line and associate director of Cancer Screening and Prevention for the Institute for Cancer Research.
In Brief
Bob Purcell was named chief communications officer at The Parker Institute for Cancer Immunotherapy.
In Brief
Frank Smith was named president of XenoSTART’s preclinical business unit at the START Center for Cancer Research.
In Brief
The Advanced Research Projects Agency for Health, an agency within HHS, announced the seven research teams across the United States funded through its PROactive Solutions for Prolonging Resilience program.
Clinical Roundup
High-level results from the randomized, controlled NHS-Galleri trial, which is evaluating GRAIL’s multi-cancer screening test, Galleri, over three years in 142,000 participants aged 50 to 77, reveals that the trial did not meet its primary endpoint of shifting cancer diagnosis from advanced stages (3 and 4) to earlier stage (1 and 2).
Clinical Roundup
The results from first-in-human portion of the ongoing phase I/II PYNNACLE study evaluating rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation highlighted the antitumor activity of rezatapopt in heavily pretreated patients across multiple solid tumor-types, establishing proof-of-concept for p53 reactivation.
Clinical Roundup
Small fragments of plastic were found in nine out of 10 patients with prostate cancer, and in higher levels inside tumors than in nearby noncancerous tissue, according to a study led by NYU Langone Health, its Perlmutter Cancer Center, and its Center for the Investigation of Environmental Hazards.
Clinical Roundup
ROSELLA phase III trial of relacorilant plus nab-paclitaxel to treat patients with platinum-resistant ovarian cancer met its overall survival primary endpoint.
Clinical Roundup
Data from the phase Ib/II OrigAMI-4 study found that first-line treatment with investigational subcutaneous amivantamab and hyaluronidase-lpuj in combination with a PD-1 inhibitor delivered clinically meaningful and durable antitumor activity in patients with head and neck squamous cell carcinoma that is recurrent or metastatic, PD-L1-positive, and HPV-unrelated.
Clinical Roundup
Pairing a next-generation immunotherapy with standard hormone therapy before surgery may help overcome a long-standing barrier in early-stage prostate cancer treatment, according to a Mayo Clinic-led study.
Clinical Roundup
The American Heart Association’s 2024 Predicting Risk of Cardiovascular Disease Events equations can identify testicular cancer survivors at heightened risk for future cardiovascular events, according to a study led by researchers at Indiana University and Medical College of Wisconsin.
Clinical Roundup
Many therapeutic molecules used in cancer treatments are highly toxic, often harming healthy tissues and causing significant side effects. This creates a critical need for strategies that localize their toxic activity to tumors. What if cancer drugs could stay dormant until they reach cancer cells? A study by Syracuse University researchers demonstrates a promising chemistry-based strategy that could do just that.
Clinical Roundup
Testicular cancer survivors treated with four cycles of etoposide and cisplatin had significantly higher odds of renal impairment, hearing loss, and peripheral neuropathy compared with those treated with three cycles of bleomycin, etoposide, and cisplatin, according to a large, multi-center study. Nearly 41% of all survivors in the study showed some degree of at least mild renal dysfunction, which was strongly associated with cumulative cisplatin dose.
Clinical Roundup
Androgen receptor alterations consistently emerged in serial liquid biopsies researchers used to track how metastatic prostate cancer evolves under treatment pressure. These alterations were linked to poorer outcomes across therapies, according to a multi-center collaboration of investigators from Sylvester, UC San Diego, Moores Cancer Center, the University of California, San Francisco, Scripps Research Institute, and Guardant Health.
Clinical Roundup
For many women with breast cancer, the treatment that saves their lives also brings fatigue that clings like a heavy coat, loss of muscle mass that turns everyday tasks into obstacles and emotional strain that lingers long after each infusion ends. It’s a season defined not just by survival, but by how well patients are able to live through it.
Clinical Roundup
Long-term data on patients treated with a standard chemoimmunotherapy combination show relapse rates dropped over time and 70% of patients were still alive 15 years later, with an overall cure rate estimated at 42% of patients treated, according to a study led by scientists at SWOG, Fred Hutch Cancer Center, and the University of Rochester Medical Center.
Drugs & Targets
FDA granted full approval to Braftovi (encorafenib) in combination with cetuximab (Erbitux) and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation based on results from the global phase III BREAKWATER trial.
Drugs & Targets
FDA approved Hernexeos (zongertinib tablets) for the treatment of adult patients with advanced non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations, as detected by an FDA-authorized test.
Podcast
“About a year ago, in January, were these two massive fires in Los Angeles: the Palisades fire, and the Eaton Fire,” Sara Willa Ernst, reporter with The Cancer Letter, said on The Cancer Letter Podcast. On this week's episode, Sara and Jacquelyn Cobb, associate editor with The Cancer Letter, talk about their experience working as writer-and-editor duo on The Cancer Letter’s most recent cover story, which featured emerging data about the toxic exposure and cancer risk caused by the Eaton and Palisades fires—specifically focused on the firefighters who were sent to fight them.
The call to Fire Captain Brian Buchanan and his crew came at midnight. Northern California firefighters were urgently needed to help fight the wildfires that were devouring big swaths of Los Angeles.
News Analysis
NIH Director Jay Bhattacharya has taken a second big job.
Podcast
Malcolm V. Brock, director of Clinical and Translational Research in Thoracic Surgery at Johns Hopkins Kimmel Comprehensive Cancer Center, grew up in Bermuda. His father insisted that his children branch outside the small island—the country has a population of just over 60,000 people—and challenge themselves abroad.
Guest Editorial
Independent oncology practices are facing unprecedented operational strain as reimbursement pressures, cybersecurity obligations, capital needs, and staffing challenges converge.
Guest Editorial
Approximately 21 years ago, I had the privilege of working and helping to pass Proposition 71, which authorized $3 billion dollars in state bonds to fund stem cell research in California.
Sponsored
Autoimmune and inflammatory diseases arise when the immune system becomes misdirected, attacking the tissues it is meant to protect.
Cancer Policy
For decades, FDA commissioners sought to insulate the agency’s professional staff from political interference with regulatory decisions.
Cancer Policy
Bayer, the owner of the herbicide Roundup, offered $7.25 billion to settle thousands of lawsuits alleging that the product is responsible for causing cases of Non-Hodgkin lymphoma.
In Brief
After leading unprecedented growth of St. Jude Children’s Research Hospital over the past 12 years, James R. Downing will step down as president and CEO in late 2026 as part of a planned leadership transition, St. Jude officials said.
In Brief
Alice Soragni, an expert in patient-derived tumor organoids and functional precision oncology, has joined the University of Colorado Anschutz.
In Brief
A WVU Cancer Institute team has achieved a global medical first in a clinical trial examining the efficacy of subcutaneous blinatumomab (Blincyto) in treating one of the rarest and most aggressive forms of leukemia.
In Brief
UNC Health is incorporating proton therapy into its established radiation oncology program at UNC Hospitals in Chapel Hill.
In Brief
The University of Illinois Cancer Center has created training program focused on cancer prevention and survivorship for the next generation of leaders in preventive medicine and primary care.
In Brief
The governing board of the Cancer Prevention and Research Institute of Texas met in Austin and approved more than $15 million in CPRIT Scholar recruitment grants to bring five new cancer scientists to four Texas research institutions.
