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Showing 1 - 50FDA Approves Durvalumab Plus BCG for High-Risk NMIBC
On May 28, 2026, the U.S. Food and Drug Administration (FDA) approved the PD-L1 inhibitor durvalumab (Imfinzi) in combination with bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-naive, high-risk non–muscle-invasive bladder cancer (NMIBC). Efficacy and Safety Efficacy...
BPDCN: FDA Approves Pivekimab Sunirine-pvzy
On May 27, the U.S. Food and Drug Administration (FDA) approved pivekimab sunirine-pvzy (Decnupaz), a CD123-directed antibody and alkylating agent conjugate, for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN). CADENZA Efficacy was evaluated in CADENZA (ClinicalTrials.gov...
Using Artificial Intelligence to Prescribe Cancer Drugs and Perform Other Tasks
In a recent article in The ASCO Post, we discussed increasing use of artificial intelligence (AI) in oncology and how physician-complementing AI can empower oncologists to be even better at what they do.1The reason AI is needed is that increasingly many variables need to be considered in cancer...
ASCO Expands Landmark TAPUR™ Trial
ASCO has expanded its Targeted Agent and Profiling Utilization Registry (TAPUR™) Study with two new developments: The study added its first antibody-drug conjugate, fam-trastuzumab deruxtecan-nxki (T-DXd), to determine if a wider group of patients would benefit from this medicine. Separately, the...
Four Ways AI Is Transforming Patient Care—and What Lies Ahead
During her Presidential address at the 2025 ASCO Annual Meeting, Robin T. Zon, MD, FACP, FASCO, assessed how artificial intelligence (AI) is driving knowledge into action in the field of oncology, and acknowledged that “we are now at the crossroads of long-imagined possibilities and actionable...
FDA Approves Antibody-Drug Conjugate for Triple-Negative Breast Cancer
On May 22, the U.S. Food and Drug Administration (FDA) approved datopotamab deruxtecan-dlnk (Datroway), an antibody-drug conjugate targeting trophoblast cell surface antigen 2 (TROP2), for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for ...
FDA Approves Fam-Trastuzumab Deruxtecan-nxki Indications in HER2-Positive Early Breast Cancer
On May 15, 2026, the U.S. Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki (T-DXd) (Enhertu) for two separate indications for the treatment of adult patients with HER2-positive early-stage breast cancer. The first indication is for the neoadjuvant treatment of adult...
FDA Approves Atezolizumab for Adjuvant Treatment of MRD-Positive Muscle-Invasive Bladder Cancer
On May 15, the U.S. Food and Drug Administration (FDA) approved the PD-L1 inhbitor atezolizumab (Tecentriq) and atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) as adjuvant therapies for adults with muscle-invasive bladder cancer (MIBC) after cystectomy who have circulating tumor DNA...
Relacorilant Plus Nab-Paclitaxel Improves Overall Survival in Platinum-Resistant Ovarian Cancer
Final overall survival results from the phase III ROSELLA trial showed a statistically and clinically significant survival benefit with the selective glucocorticoid receptor antagonist relacorilant plus nab-paclitaxel vs nab-paclitaxel alone in patients with platinum-resistant ovarian cancer....
Sonrotoclax Receives Accelerated Approval in Relapsed or Refractory MCL
On May 13, the U.S. Food and Drug Administration (FDA) granted accelerated approval to sonrotoclax (Beqalzi), a BCL-2 inhibitor, for adults with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor....
FDA Approves Combination Regimen for Newly Diagnosed AML
On May 13, the U.S. Food and Drug Administration (FDA) approved an oral combination of decitabine and cedazuridine tablets (Inqovi) plus venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults aged 75 years or older or who have comorbidities that preclude them from...
FDA Approves Zenocutuzumab-zbco for Advanced, Unresectable, or Metastatic NRG1-Mutated Cholangiocarcinoma
The U.S. Food and Drug Administration (FDA) approved the HER2- and HER3-directed bispecific antibody zenocutuzumab-zbco (Bizengri) for adults with advanced, unresectable or metastatic cholangiocarcinoma harboring an NRG1 gene fusion with disease progression on or after prior systemic therapy. The...
National Academy of Medicine Recognizes 100 Newly Elected Members
Overview of Member Election Election to the National Academy of Medicine recognizes individuals who have demonstrated outstanding professional achievement and commitment to service. New members are elected by current members through a process that acknowledges individuals who have made major...
FDA Permits Expanded Access for Investigational Pancreatic Cancer Drug
On May 1, the U.S. Food and Drug Administration announced that it issued a “safe to proceed” letter to Revolution Medicines, allowing the sponsor to initiate an expanded access treatment protocol (EAP) for its experimental pancreatic cancer drug, daraxonrasib. In mid-April, Revolution Medicines...
FDA Approves Vepdegestrant for ER-Positive, HER2-Negative, ESR1-Mutated Advanced Breast Cancer
On May 1, the U.S. Food and Drug Administration (FDA) approved vepdegestrant (Veppanu), a heterobifunctional protein degrader, for the treatment of adult patients with estrogen receptor (ER)-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized ...
RAS Inhibitor Daraxonrasib in Metastatic Pancreatic Cancer
The treatment landscape for advanced pancreatic cancer is shifting. The common RAS mutation is now targetable and the race for the most effective inhibitor is heating up. In mid-April, Revolution Medicines announced positive results from its phase III RASolute 302 clinical trial of daraxonrasib, an ...
Case 1: Advanced and Recurrent MMRd Endometrioid Adenocarcinoma of the Uterus
This is Part 1 of Navigating the Immunotherapy Landscape in Advanced/Recurrent Endometrial Cancer, a three-part video roundtable series. Scroll down to watch the other videos from this roundtable. In this video, Drs. Krishnansu Tewari, Noelle Cloven, and Alyssa Bujnak discuss the management of...
Unique Phase I NSCLC Trial Sites Decreasing in United States
The number of unique clinical trial sites in the United States with phase I studies for patients with non–small cell lung cancer (NSCLC) decreased by 44% from 2020 to 2024, showing a significant consolidation of studies to only high trial volume sites in the country, according to the results of a...
High-Risk Smoldering Multiple Myeloma: BCMA-Directed CAR T-Cell Therapy Shows Activity
A single infusion of the chimeric antigen receptor (CAR) T-cell therapy ciltacabtagene autoleucel led to a 100% measurable residual disease (MRD)-negativity rate in patients with high-risk smoldering multiple myeloma, according to results from CAR-PRISM, a phase II clinical trial, presented at the...
Elisrasib Demonstrates High Disease Control Rate in KRAS G12C–Mutant NSCLC
Elisrasib, a next-generation KRAS G12C inhibitor, demonstrated disease control in a majority of patients with KRAS G12C–mutated non–small cell lung cancer (NSCLC), whether exposed to a prior KRAS G12C inhibitor or not, according to findings from an ongoing phase I/II clinical trial presented at the ...
Zoldonrasib in Patients With KRAS G12D–Mutant NSCLC Previously Treated With Chemoimmunotherapy
The investigational KRAS G12D inhibitor zoldonrasib had a favorable safety profile and induced antitumor activity in some patients with KRAS G12D–mutated non–small cell lung cancer (NSCLC) who were previously treated with chemotherapy and immunotherapy, according to preliminary findings from an...
ASCO Expands TAPUR Trial With Two New Precision Drug Arms
ASCO has expanded its Targeted Agent and Profiling Utilization Registry (TAPUR™) study with two new developments: The study added its first antibody-drug conjugate (ADC), fam-trastuzumab deruxtecan-nxki (T-DXd), to determine if a wider group of patients would benefit from this medicine....
Is Standard of Care Optimal for the Individual Patient?
I am writing this from the hospital waiting room. My father is undergoing an 11-hour surgery to remove his parotid gland and a squamous cell carcinoma that has metastasized from his cheek and invaded his facial nerve. Several weeks ago, when the PA’s fingers moved over the mass visibly protruding...
Antoni Ribas, MD, PhD, Honored With the 2026 AACR-Margaret Foti Award for Leadership and Extraordinary Achievements in Cancer Research
The American Association for Cancer Research (AACR) will present the 2026 AACR-Margaret Foti Award for Leadership and Extraordinary Achievements in Cancer Research to Antoni Ribas, MD, PhD, Fellow of the AACR Academy, during the AACR Annual Meeting 2026, to be held April 17 to 22 in San Diego. Dr. ...
Long-Term Outcomes With Pralsetinib in RET Fusion–Positive NSCLC
Long-term follow-up of the oral selective RET inhibitor pralsetinib in patients with advanced non–small cell lung cancer (NSCLC) and a RET fusion confirms its efficacy and safety, according to final findings from the phase I/II ARROW trial published in the Journal of Clinical Oncology. “Before...
FDA Grants Traditional Approval to Brexucabtagene Autoleucel for Relapsed or Refractory MCL
The U.S. Food and Drug Administration (FDA) has granted traditional approval to the chimeric antigen receptor (CAR) T-cell therapy brexucabtagene autoleucel (Tecartus) for adult patients with relapsed or refractory mantle cell lymphoma (MCL). The full approval now includes efficacy, safety, and...
AI Use in Cancer Diagnosis, Prognosis, and Treatment: Are We There Yet?
The promise of artificial intelligence (AI) technologies to provide highly personalized oncology care for patients and improve outcomes has been decades in the making. In a 1987 editorial in The New England Journal of Medicine, pioneering nephrologist and health economist William B. Schwartz, MD,...
FDA Approves Relacorilant With Nab-Paclitaxel for Several Platinum-Resistant Gynecologic Cancers
On March 25, the U.S. Food and Drug Administration (FDA) approved relacorilant (Lifyorli), a glucocorticoid receptor antagonist, in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received...
New First-Line Targeted Therapy Recommendations Among Updated ASCO Guidance on Gastroesophageal Cancer Management
ASCO has released a guideline update addressing advances in the use of immunotherapy and targeted therapy for the treatment of advanced gastroesophageal cancer.1 The guideline, last updated in 2023 to include first-line therapy recommendations for patients with biomarkers such as PD-L1 and HER2,...
FDA Approves Chemoimmunotherapy Regimen for Hodgkin Lymphoma
On March 20, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) with doxorubicin, vinblastine, and dacarbazine (AVD) for adult and pediatric patients aged 12 years and older with previously untreated stage III or IV classical Hodgkin lymphoma. The FDA also granted traditional...
Adjuvant Pembrolizumab Plus Belzutifan May Provide a New Standard of Care for Patients With Renal Cell Carcinoma at Increased Risk of Recurrence
Based on results from the phase III KEYNOTE-564 study,1 adjuvant pembrolizumab is currently a standard of care for patients with clear cell renal cell carcinoma who have an increased risk of recurrence following a nephrectomy. Now, results from the phase III LITESPARK-022 study investigating the...
FDA Consolidates Systems Into One Cohesive Adverse Event Monitoring Tool
The U.S. Food and Drug Administration (FDA) has launched a new platform, called the FDA Adverse Event Monitoring System (AEMS), for analyzing adverse events from drugs and products. The platform consolidates multiple prior reporting systems in an effort to modernize and increase transparency into...
FDA Releases Updated Guidance on Biosimilar Development
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...
SABCS 2025: High-Level Review of Select Data
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...
FDA Approves Teclistamab and Daratumumab For Relapsed or Refractory Multiple Myeloma
On March 5, 2026, the U.S. Food and Drug Administration (FDA) approved teclistamab (Tecvayli) in combination with daratumumab hyaluronidase-fihj for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a...
Advanced RCC: After Immunotherapy, Belzutifan Plus Lenvatinib or Cabozantinib?
At the 2026 ASCO Genitourinary Cancers Symposium, Robert J. Motzer, MD, of Memorial Sloan Kettering Cancer Center, presented results from the second interim analysis of the phase III LITESPARK-011 trial showing improved progression-free survival, higher objective response rate, and a trend toward...
Advanced Nonsquamous NSCLC: FDA Grants Accelerated Approval to Zongertinib
On February 26, the U.S. Food and Drug Administration (FDA) granted accelerated approval to zongertinib (Hernexeos), a kinase inhibitor, for an expanded indication for adults with unresectable or metastatic nonsquamous non–small cell lung cancer (NSCLC) whose tumors have HER2 tyrosine kinase domain ...
Intravesical Immunotherapy Shows Recurrence Control in BCG-Unresponsive Papillary-Only Non–Muscle-Invasive Bladder Cancer
Intravesical treatment with the investigational immunotherapy cretostimogene grenadenorepvec (CG0070) demonstrated “strong” high-grade recurrence-free survival rates in patients with high-risk, papillary-only, bacillus Calmette-Guérin (BCG)-unresponsive non–muscle-invasive bladder cancer, according ...
FDA Approves Encorafenib for Metastatic BRAF V600E–Mutated Colorectal Cancer
On February 24, the U.S. Food and Drug Administration (FDA) granted traditional approval to the kinase inhibitor encorafenib (Braftovi) in combination with cetuximab and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation, ...
Introducing ASCO AI in Oncology
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’s First Living Guideline in GU Cancers Reflects Recent Practice-Changing Trials on Systemic Treatment of mCRPC
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...
CLL/SLL: FDA Approves Combination of Acalabrutinib and Venetoclax
On February 19, the U.S. Food and Drug Administration (FDA) approved the Bruton’s tyrosine kinase inhibitor acalabrutinib (Calquence) tablets and capsules in combination with the BCL2 inhibitor venetoclax (Venclexta) for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma...
Multidisciplinary Radiopharmaceutical Therapy Symposium: Highlights From the Inaugural New Meeting From ASTRO
New research highlighting the growing potential of radiopharmaceutical therapies (RPT) to improve outcomes for people with cancer was presented at the inaugural Multidisciplinary Radiopharmaceutical Therapy Symposium, which took place in Palm Desert, California, and online on February 17 and 18....
Topline Progression-Free Survival Results From BREAKWATER in Metastatic Colorectal Cancer Newly Announced
Pfizer has announced positive topline progression-free survival results from cohort 3, a separate randomized cohort of the pivotal BREAKWATER trial, evaluating encorafenib in combination with cetuximab and FOLFIRI (fluorouracil, leucovorin, and irinotecan) in patients with previously untreated...
FDA Approves Once-Monthly Dosing Schedule for Amivantamab and Hyaluronidase-lpuj
Today, Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved a new, simplified monthly dosing schedule for amivantamab and hyaluronidase-lpuj (Rybrevant Faspro). When administered in combination with oral lazertinib for the first-line treatment EGFR-mutated...
FDA Approves Labeling Changes to Menopausal Hormone Therapy Products
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, ...
FDA Approves TTFields Device for Pancreatic Cancer
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...
FDA Approves Pembrolizumab With Paclitaxel for Platinum-Resistant Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma
On February 10, the U.S. Food and Drug Administration (FDA) approved the PD-1 inhibitor pembrolizumab (Keytruda) as well as pembrolizumab and the recombinant human enzyme,berahyaluronidase alfa-pmph (Keytruda Qlex) in combination with paclitaxel, with or without bevacizumab. [Pembrolizumab plus...
MajesTEC-3: ‘Unprecedented’ Benefit in Previously Treated Multiple Myeloma
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 ...
FDA Provides Safety Labeling Update for Capecitabine and Fluorouracil on Risks Associated With DPD Deficiency
The U.S. Food and Drug Administration (FDA) has provided communication to increase awareness of recent updates to the product labeling of capecitabine (Xeloda) and fluorouracil—indicated for colorectal, breast, gastric/esophageal/gastroesophageal, and pancreatic cancers—related to risks associated...
