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Showing 1 - 50FDA 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...
Pirtobrutinib Improves Progression-Free Survival vs Bendamustine/Rituximab in Front-Line CLL/SLL
The first prospective, randomized phase III trial of a noncovalent Bruton’s tyrosine kinase (BTK) inhibitor exclusively in treatment-naive patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)—BRUIN CLL-313—demonstrated a statistically significant and clinically...
Multiple Myeloma: FDA Approves Daratumumab and Hyaluronidase-fihj in Combination With VRd
On January 27, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous...
Evolving Treatment Landscape Spurs Living Guideline Update on Multiple Myeloma
ASCO, in collaboration with Ontario Health (Cancer Care Ontario), has published an update to their previous guideline on the treatment of multiple myeloma.1 This new guideline—which has been selected as an ASCO Living Guideline—reflects dramatic changes that have helped improve the management of...
FDA Releases Draft Guidance for Use of MRD and CR as Primary Endpoints in Multiple Myeloma Trials
On January 20, 2026, the U.S. Food and Drug Administration (FDA) released a draft guidance for industry regarding the use of minimal residual disease and complete response as primary endpoints in clinical trials evaluating drugs and biologics for the treatment of patients with multiple myeloma that ...
Popular Supplement May Interfere With Cancer Treatment
For many patients with cancer, hair loss can be one of the most distressing side effects of their therapy. Increasingly, patients have been taking oral supplements of biotin, which are marketed to consumers for their potential to improve hair regrowth and brittle nails. However, there is little...
Regulatory Agencies Establish Principles of Good AI Use in Drug Development
The U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have collaborated with the European Medicines Agency (EMA) to develop a set of 10 guiding principles for good uses of artificial intelligence (AI) in...
FDA Increases Flexibility on Requirements for Cell and Gene Therapies
The U.S. Food and Drug Administration (FDA) has announced it is sharing information about the agency’s flexible approach to overseeing chemistry, manufacturing, and control (CMC) requirements for cell and gene therapies (CGTs). The agency’s more flexible approach has been, and is expected to...
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 Approves Amivantamab and Hyaluronidase-lpuj for Subcutaneous Injection
On December 17, the U.S. Food and Drug Administration (FDA) approved amivantamab and hyaluronidase-lpuj (Rybrevant Faspro) for subcutaneous injection for adult patients across all indications approved for the intravenous formulation of amivantamab (Rybrevant). PALOMA-3 The subcutaneous injection of ...
FDA Grants Regular Approval to Rucaparib for Metastatic Castration-Resistant Prostate Cancer
On December 17, the U.S. Food and Drug Administration (FDA) approved the PARP inhibitor rucaparib (Rubraca) for adults with deleterious BRCA mutation (germline and/or somatic)–associated metastatic castration-resistant prostate cancer previously treated with an androgen receptor–directed therapy....
Intravesical Cretostimogene Grenadenorepvec Shows Strong High-Grade Recurrence-Free Survival in BCG-Unresponsive Papillary-Only Non–Muscle-Invasive Bladder Cancer
Intravesical cretostimogene grenadenorepvec (CG0070) monotherapy 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 to data presented at the 26th Annual...
Flipped Nivolumab/Ipilimumab Dosing Improves Responses, Survival, and Safety in Advanced Melanoma
The flipped dose for nivolumab at 3 mg/kg and ipilimumab at 1 mg/kg led to improved response rates and survival findings as well as lower severe immune-related toxicities compared with the standard dose of the immunotherapy combination in patients with advanced unresectable melanoma, according to...
HER2-Positive Breast Cancer: FDA Approves T-DXd Plus Pertuzumab
On December 15, the U.S. Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) in combination with pertuzumab for the first-line treatment of adults with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer, as determined by an FDA-approved...
FDA Approves Regimen for BRCA2-Mutated Metastatic Castration-Sensitive Prostate Cancer
On December 12, the U.S. Food and Drug Administration (FDA) approved the PARP inhibitor niraparib and the hormone therapy abiraterone acetate (Akeega) with prednisone for adults with deleterious or suspected deleterious BRCA2-mutated metastatic castration-sensitive prostate cancer, as determined by ...
AI Tops Density in Predicting Breast Cancer Risk
An image-only artificial intelligence (AI) model for predicting the 5-year risk of breast cancer provided stronger and more precise risk stratification than breast density assessment, according to a news statement issued about a study presented at the annual meeting of the Radiological Society of...
Ironically, Smoking May Have Saved My Life
I was diagnosed with stage IV non-small cell lung (NSCLC) adenocarcinoma on August 1, 2013—World Lung Cancer Day. If it hadn’t been for an article that caught my eye the year before about the recommendation from the United States Preventive Services Task Force that all men aged 65 to 75 who have...
ASCO Statement: HHS Revision of Black Box Warning for Hormone Replacement Therapy and its Implications for Cancer Care
On November 10, 2025, the Department of Health and Human Services announced that the Food and Drug Administration will begin to remove the “black box” warning language related to increased risks of cardiovascular disease, breast cancer, and probable dementia from hormone replacement therapy (HRT)...
Mount Sinai Tisch Cancer Center Receives Comprehensive Cancer Center Designation and Funding from National Cancer Institute
The Mount Sinai Tisch Cancer Center (TCC) has been named a Comprehensive Cancer Center by the National Cancer Institute (NCI), the highest designation awarded to cancer centers in the United States. This recognition places Mount Sinai among the top one percent of cancer centers nationwide and...
Research Supports FDA Approval of Sevabertinib for HER2-Mutant Lung Cancer
The U.S. Food and Drug Administration (FDA) has approved sevabertinib, an oral targeted therapy, for adult patients with non-small-cell lung cancer (NSCLC) whose tumors harbor certain HER2 (ERBB2) mutations and who have previously received chemotherapy or immunotherapy. The approval reflects a...
New FDA-Approved Oncology Drugs and Label Updates Between December 1, 2024, and November 19, 2025
Over the past year (December 2024–November 19, 2025), the U.S. Food and Drug Administration (FDA) approved and expanded indications for many drugs related to the treatment of different types of cancers. The new approvals and accelerated approvals are listed below according to the most recent new...
New Pooled Analysis Strengthens Case for MRD as Surrogate Endpoint in AML
Measurable residual disease (MRD), regardless of the method of assessment, is a robust individual-level predictor for overall survival among patients with acute myeloid leukemia (AML) who have already received induction therapy, according to findings from a pooled analysis presented at the 2025...
Sacituzumab Tirumotecan Improves Survival in EGFR-Mutated NSCLC After Tyrosine Kinase Inhibitor Failure
Sacituzumab tirumotecan, a novel TROP2 antibody-drug conjugate, was found to significantly improve both progression-free and overall survival compared with platinum-based chemotherapy in patients with EGFR-mutated non–small cell lung cancer (NSCLC) who had experienced disease progression following...
FDA Approves CAR T-Cell Therapy for Relapsed/Refractory Marginal Zone Lymphoma
On December 4, 2025, the U.S. Food and Drug Administration (FDA) approved the CD19-directed chimeric antigen receptor (CAR) T-cell therapy lisocabtagene maraleucel (Breyanzi) for the treatment of adult patients with relapsed or refractory marginal zone lymphoma who have received at least two prior...
ASCO Statement on the Departure of Richard Pazdur, MD, From the FDA
Richard Pazdur, MD, Director of the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration (FDA) and former long-time head of the FDA Oncology Center of Excellence (OCE), is leaving the FDA. Dr. Pazdur has served the FDA for 26 years and is an expert in drug regulation....
Upfront Reduced-Dose Enfortumab Vedotin With Pembrolizumab in First-Line Treatment of Advanced Urothelial Cancer
In a U.S. retrospective cohort study reported in JAMA Oncology, Chow et al found that reduced-dose vs standard upfront enfortumab vedotin-ejfv plus pembrolizumab reduced the risk of enfortumab vedotin treatment interruption in the first-line treatment of patients with advanced urothelial cancer....
