The U.S. Food and Drug Administration (FDA) has released a new draft guidance to streamline the development of biosimilars. This, and prior versions of the draft guidance for industry, reflect actions being taken by the agency to lower the cost of drugs. “Streamlining biosimilar development...
The 2025 San Antonio Breast Cancer Symposium (SABCS 2025) featured some exciting presentations. The early breast cancer highlights at SABCS 2025 included the landmark lidERA trial, which explored the efficacy of the oral selective estrogen receptor degrader (SERD) giredestrant in the adjuvant...
In a study of adults with advanced prostate cancer taking androgen-receptor pathway inhibitors (ARPIs) and different types of anticoagulants, investigators found no evidence of an increase in patients’ bleeding or clotting risks, despite previous lab results that raised alarms. These findings were...
Building upon the foundation of liquid biopsy utility for the early detection of cancer, analysis of genome-wide cell-free DNA fragmentation with machine learning classification and modeling can also extend to the identification of liver cirrhosis and other chronic diseases, according to findings...
Researchers have identified that the reporting of venous and arterial thrombotic events in cancer clinical trials is inconsistent and potentially inaccurate, according to a comments article published in the Journal of Clinical Oncology.1 “Mandatory and uniform reporting of all [venous and arterial...
A novel KRAS G12D inhibitor produced disease control in almost 80% of patients with heavily pretreated advanced or metastatic KRAS G12D–mutated pancreatic cancer in an early-phase study reported at the 2026 ASCO Gastrointestinal (GI) Cancers Symposium.1 Of 41 evaluable patients treated with...
A large national study in Denmark following nearly 1,900 patients over almost a decade found that minimally invasive ablation is as effective as surgery for treating small kidney cancers, with faster recovery and fewer complications. Results of the study were published by Ahrenfeldt et al in...
Artificial intelligence (AI) tools that detect molecular biomarker status from histologic images may be dependent upon correlational relationships with clinicopathologic features, preventing the models from learning the true causal effect of the biomarker, according to findings published in Nature...
Combining a visual inspection of the bladder—systematic endoscopic evaluation—with a blood test to check for the presence of circulating tumor DNA (ctDNA) may accurately predict which patients with bladder cancer still have cancer in their bladder after treatment and which do not. These findings,...
Advanced-stage follicular lymphoma is currently considered incurable. But a new analysis of long-term data from patients treated for the disease years ago with standard regimens of immunotherapy and a chemotherapy combination known as CHOP suggests that many of those patients can now be considered...
In a new study published in Clinical Gastroenterology and Hepatology, Johnson et al reported that an automated artificial intelligence (AI) pipeline using large language models (LLMs) can accurately stratify future risk of advanced neoplasia in patients with colitis-associated low-grade dysplasia....
Circulating tumor DNA (ctDNA) may be used to predict metastatic risk and identify which patients with muscle-invasive bladder cancer are more likely to benefit from a bladder-sparing treatment approach, according to findings from the RETAIN trials presented at the 2026 ASCO Genitourinary Cancers...
Skin fluorescent imaging showed high sensitivity and specificity for the discrimination of low- and high-risk lesions, demonstrating an alternative, noninvasive approach to melanoma biopsies, according to findings from a phase II trial published in JAAD International. “By identifying the molecular ...
The results from the randomized phase III KEYNOTE-B15/EV-304 study show that neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab significantly improved event-free survival, overall survival, and pathologic complete response rate in patients with muscle-invasive bladder cancer who were...
In time for the assigned deadline of February 23, 2026, medical societies, companies, health-care systems, and more have responded to a request for information from the Department of Health and Human Services (HHS) regarding the use of artificial intelligence (AI) in clinical practice. The Request...
Prostate specific antigen (PSA) screening remains one of the most controversial of “standard” medical practices. As recently as the 2026 Super Bowl, one of the more unusual TV advertisements, sponsored by a pharmaceutical company with an interest in prostate cancer treatments, extolled the virtues ...
Among the high-quality abstract presentations at the annual San Antonio Breast Cancer Symposium (SABCS), a few always stand out as particularly meritorious. Each year, The ASCO Post asks its Senior Deputy Editor, breast cancer specialist Jame Abraham, MD, FACP, to offer his top picks for most...
Each year in the United States, about 90,000 adolescents and young adults (AYAs), ages 15 to 39, are diagnosed with cancer,1 and they are immediately faced with myriad challenges and disruptions in their life stages, including psychosocial distress; interruptions in their education, career, and...
Long-term effects on renal function, cardiovascular risk, and overall health burden in survivors of testicular cancer differed according to the chemotherapy regimen each patient received, according to the results of a large real-world study published in JNCCN—Journal of the National Comprehensive...
A year ago, I was confronting a series of symptoms—including rapid weight loss, abdominal distress, fatigue, and heart issues—that I couldn’t explain. I was just 60 years old and had been in good health, but now I sensed that something was seriously wrong. I made appointments with my primary care...
In February, ASCO and Conexiant launched ASCO AI in Oncology (ascoai.org), a digital platform dedicated to understanding how artificial intelligence (AI) is impacting cancer care. “Our goal with this hub is to empower oncology professionals with knowledge and the tools to adapt to a rapidly...
ASCO has published an updated guideline on systemic therapy for patients with metastatic castration-resistant prostate cancer (mCRPC), representing ASCO’s first Living Guideline in the area of prostate cancer and the first in any genitourinary (GU) cancer.1 “Guidelines will become less useful if...
Researchers have reported findings that may help redefine treatment for patients with muscle-invasive bladder cancer, a potentially aggressive form of the disease that is traditionally treated with surgical removal of the bladder. The study, published by Matthew D. Galsky, MD, and colleagues in the ...
Researchers have developed a new computational approach designed to better account for changes in gene expression within tumors relative to their unique microenvironments. This approach outperformed current methods for predicting chemotherapy response in patients with triple-negative breast ...
The bispecific antibody odronextamab plus standard CHOP (cyclophosphamide, vincristine, doxorubicin, prednisone) chemotherapy yielded robust and durable responses in treatment-naive patients with diffuse large B-cell lymphoma (DLBCL), based on the first results of the phase III OLYMPIA-3 study...
Researchers developed a deep neural network, M-PACT, to identify and classify brain tumors in pediatric patients from the subnanogram-input cell-free DNA of methylomes, according to findings published in Nature Cancer. “This is a next-generation assay and computational framework that we’ve...
Pleurectomy/decortication can be completed safely in select patients with pleural mesothelioma with low postoperative mortality, according to findings from a study published in The Annals of Thoracic Surgery. “Our findings show that pleurectomy/decortication can be done safely when patients are...
A remotely delivered, behaviorally designed game-based intervention was found to increase physical activity and may have implications for cardiovascular health among Black and Hispanic breast and prostate cancer survivors with cardiovascular risk factors compared with attention control, according...
In a prospective, longitudinal cohort study published in JACC: CardioOncology by Glen et al, cancer therapy–related cardiac dysfunction and hypertension were found to be common cardiovascular adverse events among patients with melanoma who received BRAF or MEK inhibitor therapy. Nearly half of...
Patients in rural areas who received surgery locally for their lung or colon cancer had comparable surgical outcomes and mortality rates to patients who underwent surgery in an urban facility, according to the results of an analysis published in the Journal of the American College of Surgeons....
In the phase III COMMIT trial, a regimen combining atezolizumab plus bevacizumab and standard chemotherapy significantly improved progression-free survival and response rates over atezolizumab monotherapy in patients with previously untreated mismatch repair deficient (dMMR) or microsatellite...
In a study reported in the Journal of Clinical Oncology, Hendifar et al found that a computational histology artificial intelligence (CHAI)-powered platform could be used to identify whether gemcitabine-based (G-chemo) or fluoropyrimidine-based (F-chemo) chemotherapy is preferred as first-line...
The American Society of Hematology (ASH) released guidelines on front-line management of acute lymphoblastic leukemia (ALL) in adolescents and young adults (AYAs), as well as the management of relapsed or refractory disease in this population. Both guidelines, grounded in evidence-based practice,...
Aromatase inhibitors are a cornerstone of adjuvant therapy for hormone receptor–positive breast cancer, significantly reducing recurrence and mortality. However, by suppressing estrogen production, aromatase inhibitors can accelerate bone loss and increase fracture risk. To counter this,...
The U.S. Food and Drug Administration (FDA) has approved drug labeling changes to six menopausal hormone therapy products, also known as hormone replacement therapy (HRT), to clarify risk considerations for these drugs. Specifically, risk statements related to cardiovascular disease, breast cancer, ...
The American Society of Hematology (ASH) has released clinical practice guidelines on the diagnosis of light chain (AL) amyloidosis, which were published in Blood Advances. Additionally, the expert panel behind the guidelines also published a scoping review about the clinical features of systemic...
In a nationwide Korean cohort study reported in the Journal of Clinical Oncology, Park et al found that risk of young-onset pancreatic cancer was associated with increased consumption of alcohol and increased frequency of alcohol consumption. Study Details In the study, a nationwide cohort of...
The U.S. Food and Drug Administration (FDA) has approved a first-of-its-kind device for the treatment of adult patients with locally advanced pancreatic cancer. Optune Pax, developed by Novocure, is a portable, noninvasive device that delivers alternating electrical fields, known as tumor treating...
In a Swedish trial (MASAI) reported in The Lancet, Gommers et al found that artificial intelligence (AI)-supported mammography was noninferior to standard double reading without AI in identifying interval breast cancers in women undergoing breast cancer screening. Study Details In the study,...
A national survey of independent community oncology practices has found that utilization management tactics imposed by health insurers and pharmacy benefit managers (PBMs) delay cancer treatment, interfere with physician-directed care, and increase administrative and financial burdens on practices...
New research published by Nikitas et al in JNCCN—Journal of the National Comprehensive Cancer Network found that incorporating information from prostate-specific membrane antigen (PSMA) positron-emission tomography/computed tomography (PET/CT) scans may be able to predict progression-free survival...
The first-in-human clinical trial of an in vivo CAR T-cell therapy for multiple myeloma has shown encouraging clinical outcomes at an early time point, with a safety profile and ease of administration that indicates the off-the-shelf KLN-1010 could be easily deployable, researchers from Australia...
For myelofibrosis, the treatment landscape is poised for change as new targets have emerged, and treatments are evolving beyond the standard Janus kinase (JAK) inhibitors. Novel therapies are being paired with the commonly used JAK inhibitor ruxolitinib, as reflected by a wealth of studies...
In patients with CALR exon 9–mutated myelofibrosis who were resistant or intolerant to prior Janus kinase (JAK) inhibitor therapy or ineligible for such treatment, the first-in-class mutant calreticulin–specific monoclonal antibody INCA033989 as monotherapy or in combination with ruxolitinib...
In patients with follicular lymphoma who received at least one prior line of therapy, the combination of the bispecific antibody epcoritamab-bysp and rituximab–lenalidomide (R2) reduced the risk of disease progression or death by almost 80% over R2 alone, based on the primary analysis of the phase...
As front-line therapy, a chemotherapy-free regimen combining the tyrosine kinase inhibitor (TKI) ponatinib and the bispecific T-cell engager blinatumomab significantly outperformed standard treatment with imatinib plus chemotherapy in adults with newly diagnosed Philadelphia chromosome–positive...
The American Society of Clinical Oncology (ASCO®) and Conexiant today announced the launch of ASCO AI in Oncology, a premier digital destination designed to help oncology professionals navigate the transformative role of artificial intelligence (AI) in cancer care. Launching this initiative marks...
A nationwide, real-world analysis using the Society of Thoracic Surgeons (STS) General Thoracic Surgery Database (GTSD) from 2012 to 2023 evaluated over 16,000 adults who underwent esophagectomy for primary esophageal cancer to develop and validate a long-term all-cause mortality risk model. The...
For patients with previously treated multiple myeloma, the greatest risk reduction yet achieved in a phase III clinical trial was reported with the BCMA-directed CD3 T-cell engager teclistamab-cqyv plus daratumumab and hyaluronidase-fihj. Treatment with this combination resulted in an 83% reduction ...
Based on the phase III CLL17 trial, a fixed duration of targeted treatment demonstrated noninferiority to continuous treatment with respect to progression-free survival in previously untreated patients with chronic lymphocytic leukemia (CLL). The findings were presented at the Plenary Session of...