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Showing 601 - 650FDA Approves Capmatinib for Metastatic NSCLC With MET Exon 14 Skipping Mutations
On August 10, 2022, the U.S. Food and Drug Administration (FDA) granted regular approval to capmatinib (Tabrecta) for adult patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have a mutation leading to mesenchymal-epithelial transition (MET) exon 14 skipping, as detected by an ...
FDA Approves Ventana MMR RxDx Panel to Identify Patients With dMMR Solid Tumors and pMMR Endometrial Cancer Eligible for Treatment With Pembrolizumab
On August 11, Roche announced the U.S. Food and Drug Administration (FDA) approval of a label expansion for the Ventana MMR RxDx Panel. The Ventana MMR RxDx Panel is the first immunohistochemistry (IHC) companion diagnostic test to aid in identifying patients whose solid tumors are deficient in DNA ...
Characteristics of Data Supporting FDA Initial Approval and Subsequent Indications for New Cancer Drugs
In a study reported in the Journal of Clinical Oncology, Michaeli and Michaeli described data supporting U.S. Food and Drug Administration (FDA) initial approval and subsequent indications for new cancer drugs from 2003 through 2021. Study Details Clinical trial evidence supporting approval for...
ASCO-ACCC Recommendations to Reduce Barriers to Clinical Trial Enrollment
Here is a summary of the strategies developed by ASCO and the Association of Community Cancer Centers (ACCC) to increase participation by minority patients in cancer clinical trials and ensure greater equity, diversity, and inclusion in research studies. For a detailed list of the recommendations,...
FDA Approves Darolutamide for Metastatic Hormone-Sensitive Prostate Cancer
On August 5, 2022, the U.S. Food and Drug Administration approved darolutamide (Nubeqa) tablets in combination with docetaxel for adult patients with metastatic hormone-sensitive prostate cancer. The evaluation of efficacy was based on ARASENS (ClinicalTrials.gov identifier NCT02799602), a...
Global Phase III FRESCO-2 Study Has Met Its Primary Endpoint in Evaluation of Fruquintinib for Metastatic Colorectal Cancer
The pivotal global phase III FRESCO-2 trial evaluating the investigational use of fruquintinib met its primary endpoint of overall survival in patients with advanced, refractory metastatic colorectal cancer. The U.S. Food and Drug Administration (FDA) granted Fast Track designation for the...
FDA Approves First Targeted Therapy for HER2-Low Breast Cancer
On August 5, 2022, the U.S. Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki (T-DXd, Enhertu), an intravenous infusion for the treatment of patients with unresectable or metastatic HER2-low breast cancer. This is the first approved therapy targeted to patients with the...
Immunotherapy for Gastrointestinal Malignancies: Is It Ready for Prime Time?
In less than a decade, immunotherapy has reshaped the treatment landscape of cancer, but some histologies tend to be more responsive to this modality than others. During the Society of Surgical Oncology 2022 International Conference on Surgical Care, Yuman Fong, MD, of the City of Hope Medical...
Fewer People Tried to Quit Smoking During COVID-19 Pandemic, Study Shows
A new study led by researchers at the American Cancer Society (ACS), shows serious smoking cessation activity declined among adults in the United States immediately after the onset of the COVID-19 pandemic and persisted for more than a year. Declines in attempts to quit smoking were largest among...
FDA Approves Crizotinib for ALK-Positive Inflammatory Myofibroblastic Tumors
On July 14, 2022, the U.S. Food and Drug Administration (FDA) approved crizotinib (Xalkori) for adult and pediatric patients aged 1 year and older with unresectable, recurrent, or refractory inflammatory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumors. Two Trials The safety and...
FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine, Adjuvanted
On July 13, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the Novavax COVID-19 vaccine, adjuvanted, for the prevention of COVID-19 caused by SARS–CoV-2 in individuals aged 18 years and older. “Authorizing an additional COVID-19 vaccine expands the...
President Biden Appoints Cancer Panel Members, and Cancer Cabinet Unveils Priority Actions
On July 13, President Joe Biden announced his intent to appoint Mitchel Berger, MD; Carol Brown, MD; and Elizabeth M. Jaffee, MD, to the President’s Cancer Panel. The three are distinguished members of the scientific, research, and public health communities appointed by the President to advise him...
Former NCI Director Takes Stock of His Accomplishments and Looks Ahead to the Next Challenge
After nearly 5 years as Director of the National Cancer Institute (NCI), interrupted by 7 months as Acting Commissioner for the U.S. Food and Drug Administration (FDA), Norman E. “Ned” Sharpless, MD, left his position on April 29 to concentrate on his family and contemplate his next career choice....
ASCO Guideline Update for Systemic Melanoma Therapy Addresses New Treatment Option for Uveal Melanoma
A rapid update to the ASCO guideline on systemic therapy for melanoma adds a new recommendation for the treatment of patients with metastatic uveal melanoma.1 The update follows the January 2022 U.S. Food and Drug Administration (FDA) approval of tebentafusp-tebn for patients with previously...
CAR T-Cell Therapy Gave Me Back a High-Quality Life
A radiologist by training, I knew the minute I saw the results from my chest x-ray that I had multiple myeloma. In 2015, I was semiretired and had just taken up the game of golf. After making a big swing at the ball, I instantly felt pain in my ribs and thought I had either pulled an intercostal...
Cautious Optimism About Mining for Patient-Centric Data
“If we have data, let’s look at it. If all we have are opinions, let’s go with mine.” —James Barksdale In this issue of The ASCO Post, Daniel Vorobiof, MD, and Irad Deutsch, principles at Belong.Life, a patient-oriented website whose self-described mission is to improve patient quality of life and ...
FDA Launches Campaign Aimed at Preventing E-Cigarette Use Among American Indian/Alaska Native Youth
The U.S. Food and Drug Administration (FDA) recently announced the launch of the “Next Legends” Youth E-cigarette Prevention Campaign as part of the agency’s ongoing efforts to protect youth from the dangers of tobacco use. The campaign will educate American Indian/Alaska Native (AI/AN) youth, ages ...
Death and Clinical Trials in the Plague Years
“Everybody knows that pestilences have a way of recurring in the world; yet somehow, we find it hard to believe in ones that crash down on our heads from a blue sky. There have been as many plagues as wars in history; yet always plagues and wars take people equally by surprise.” —Albert Camus, The...
FDA Warns About Possible Increased Risk of Death and Serious Side Effects With Duvelisib
The U.S. Food and Drug Administration (FDA) is warning that results from the phase III DUO clinical trial show a possible increased risk of death with duvelisib compared to ofatumumab among patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The trial also found...
Chipping Away at Targetable Mutations in NSCLC: Amivantamab in NSCLC With MET Exon 14 Skipping Mutations
Dual targeting with the bispecific antibody amivantamab-vmjw showed antitumor activity and tolerability in patients with metastatic non–small cell lung cancer (NSCLC) and MET exon 14 skipping mutations, according to results of the ongoing phase I CHRYSALIS study.1,2 Updated results were presented...
Raising the Bar: Rethinking the Accelerated Drug Approval Process
Our growing knowledge of the molecular and genomic drivers of cancer has translated into a robust pipeline of promising anticancer agents. However, bringing new drugs from the lab to the patient with cancer can be frustratingly slow. To that end, the accelerated approval system was created by the...
FDA Approves Lisocabtagene Maraleucel for the Second-Line Treatment of Large B-Cell Lymphoma
On June 24, the U.S. Food and Drug Administration (FDA) approved the chimeric antigen receptor (CAR) T-cell therapy lisocabtagene maraleucel (Breyanzi) for adult patients with large B-cell lymphoma (LBCL) who have disease refractory to first-line chemoimmunotherapy or relapse within 12 months of...
Dabrafenib/Trametinib Combination Receives FDA Approval for BRAF V600E–Mutated Solid Tumors
On June 23, the U.S. Food and Drug Administration (FDA) granted accelerated approval for dabrafenib (Tafinlar) plus trametinib (Mekinist) for the treatment of adult and pediatric patients aged 6 years and older with unresectable or metastatic solid tumors with a BRAF V600E mutation whose disease...
FDA Denies Authorization to Market JUUL Products
On June 23, the U.S. Food and Drug Administration (FDA) issued marketing denial orders (MDOs) to JUUL Labs Inc for all of their products currently marketed in the United States. As a result, the company must stop selling and distributing these products. In addition, those currently on the U.S....
Gilberto de Lima Lopes, Jr, MD, MBA, and Oladimeji Akinboro, MD, MPH, on NSCLC: Outcomes of Anti–PD-(L)1 Therapy With or Without Chemotherapy in the First-Line Setting
Gilberto de Lima Lopes, Jr, MD, MBA, of Sylvester Comprehensive Cancer Center at the University of Miami, and Oladimeji Akinboro, MD, MPH, of the U.S. Food and Drug Administration (FDA), discuss a data analysis, which suggests that most subgroups of patients with advanced non–small cell lung cancer ...
Study Identifies Three-Gene Signature That May Predict Response to Selinexor in Patients With Multiple Myeloma
Researchers have, for the first time, identified genes that may predict response to a therapy for a blood cancer that can have serious side effects for some patients. The therapy, selinexor, is part of the treatment armamentarium for multiple myeloma, but the ability to target its use to patients...
FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children as Young as 6 Months of Age
On June 17, the U.S. Food and Drug Administration (FDA) authorized emergency use of the Moderna COVID-19 vaccine and the Pfizer-BioNTech COVID-19 vaccine for the prevention of COVID-19 to include use in children as young as 6 months of age. For the Moderna vaccine, the FDA amended the emergency...
Postmarketing Ocular Toxicity in U.S. Adults Treated With Daratumumab
In an analysis reported in a research letter in JAMA Oncology, Nguyen et al identified postmarketing cases of ocular toxicity in patients receiving daratumumab in the United States. Daratumumab is a CD38-directed monoclonal antibody that was initially approved in 2015 for the treatment of multiple...
Elevating Cancer Care in the United States for All: Current Challenges and Potential Solutions
Optimizing oncology care in the United States will require making state-of-the-art care more accessible to all. Delivering quality, equitable cancer care is undoubtedly a challenge in a country as large, diverse, and disparate as the United States, but if it is to be achieved, it will entail the...
Emily Whitehead, First Pediatric Patient to Receive CAR T-Cell Therapy, Celebrates Remission 10 Years Later
Tom and Kari Whitehead came to Children’s Hospital of Philadelphia (CHOP) 10 years ago looking for a miracle. Their 6-year-old daughter, Emily, had relapsed in her battle with acute lymphoblastic leukemia (ALL), after many months of unsuccessful chemotherapy and a disease that had progressed so...
FDA Approves FoundationOne CDx as a Companion Diagnostic for Entrectinib
On June 9, Foundation Medicine, Inc., announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne CDx to be used as a companion diagnostic for the two indications of the tyrosine kinase inhibitor entrectinib (Rozlytrek). As a companion diagnostic,...
Adagrasib Improves Outcomes in KRAS-Mutated NSCLC, Phase II Study Shows
Nearly 43% of patients with non–small cell lung cancer (NSCLC) whose lung cancers harbored a specific KRAS mutation responded to the experimental drug adagrasib, and the targeted agent also showed activity against lesions in the brain that metastasized from the lung tumors, according to results of...
FDA Approvals in Esophageal Cancer and Follicular Lymphoma
Last week, the FDA approved treatments for esophageal cancer and follicular lymphoma. On this episode, we’ll review the data supporting those approvals and hear from researchers involved in the trials investigating the efficacy of these regimens.
New FDA-Approved Oncology Drugs (2021–2022)
Over the past year (May 2021–May 2022), the U.S. Food and Drug Administration (FDA) approved and expanded indications for many drugs related to the treatment of different types of cancers and adverse events. The new approvals and accelerated approvals are listed below. FAM-TRASTUZUMAB...
Missed Opportunities in Geriatric Oncology Research
The underrepresentation of older patients (≥ 65 years) in clinical trials has been well documented for more than 20 years. This has been an issue at all phases of drug development, including pivotal trials for drug approvals,1 despite the fact that many of these new therapeutics will primarily be...
ASCO Honors 2022 Special Awards Recipients
ASCO and Conquer Cancer, the ASCO Foundation, will recognize researchers, patient advocates, philanthropists, teachers, and global oncology leaders who have reshaped cancer care around the world with the Society’s highest honors at the 2022 ASCO Annual Meeting in Chicago. “This year’s Special...
FDA Approves Two Nivolumab-Based Regimens as First-Line Treatments for Unresectable Advanced or Metastatic Esophageal Squamous Cell Carcinoma
On May 27, 2022, the U.S. Food and Drug Administration (FDA) approved the following for the first-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma: Nivolumab (Opdivo) in combination with fluoropyrimidine- and platinum-based chemotherapy Nivolumab in...
FDA Approves Tisagenlecleucel for Adult Patients With Relapsed or Refractory Follicular Lymphoma
On May 28, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel (Kymriah) for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy....
FDA Approval for Newly Diagnosed Acute Myeloid Leukemia
This week, we’re covering the U.S. Food and Drug Administration (FDA) approval of a doublet therapy in certain populations of patients with newly diagnosed acute myeloid leukemia. Then we’ll hear about a comparison study of treatments for patients with metastatic breast cancer and brain metastases.
FDA Approves Ivosidenib/Azacitidine for Certain Patients With Newly Diagnosed AML
On May 25, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo) in combination with azacitidine for patients with newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test in adults aged 75 or older, or who have...
ASCO Guideline Rapid Update Addresses the Use of Neoadjuvant Pembrolizumab in High-Risk Early-Stage Triple-Negative Breast Cancer
A rapid update to the ASCO Guideline on neoadjuvant therapy for breast cancer adds a recommendation on the use of pembrolizumab in patients with high-risk early-stage triple-negative breast cancer.1 The update follows a recent analysis from the randomized phase III KEYNOTE-522 trial that showed a...
A Second Edition Adds New Value to Personalized Medicine
Since the publication of the first draft of the human genome, genotyping and genomics have been integrated into standard clinical care for select cancers. But as precision medicine in oncology develops to comprise big data, proteomics, transcriptomics, molecular imaging, and more, there are...
Children’s Hospital of Philadelphia Establishes the Susan S. and Stephen P. Kelly Center for Cancer Immunotherapy
Children’s Hospital of Philadelphia (CHOP) announced it has received a significant gift from Susan and Steve Kelly, local philanthropists and long-time supporters of CHOP, to establish the Susan S. and Stephen P. Kelly Center for Cancer Immunotherapy. The new Center, led by Stephan Grupp, MD, PhD,...
PD-1 Inhibition in First-Line Treatment of Advanced Esophageal Squamous Cell Carcinoma: More to Come on New Paradigm
Esophageal cancer is associated with significant morbidity and mortality worldwide, with more than 600,000 new cases and 540,000 deaths in 2020. The squamous cell histology comprises nearly 90% of cases globally, despite its steady decline in the United States over the past 40 years. Historically,...
Pembrolizumab for MSI-H/dMMR Advanced Endometrial Carcinoma
On March 21, 2022, pembrolizumab was approved for patients with advanced endometrial carcinoma that is microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR), as determined by a U.S. Food and Drug Administration (FDA)-approved test, who have disease progression following prior...
Steven A. Rosenberg, MD, PhD, Recognized With 2022 Pezcoller Foundation–AACR International Award
The Pezcoller Foundation–American Association for Cancer Research (AACR) International Award for Extraordinary Achievement in Cancer Research was presented to Steven A. Rosenberg, MD, PhD, at the Association’s 2022 Annual Meeting, held in New Orleans. Dr. Rosenberg was honored for his discovery and ...
FDA Approves Azacitidine for Newly Diagnosed Juvenile Myelomonocytic Leukemia
On May 20, the U.S. Food and Drug Administration approved azacitidine (Vidaza) for pediatric patients with newly diagnosed juvenile myelomonocytic leukemia (JMML). AZA-JMML-001 Efficacy was evaluated in AZA-JMML-001 (ClinicalTrials.gov identifier NCT02447666), an international, multicenter,...
Mortality and Associated Factors Among Patients With Cancer vs No Cancer Infected With SARS–CoV-2
In a systematic review and meta-analysis reported in JAMA Network Open, Khoury et al found that SARS–CoV-2 infection was associated with a higher risk of mortality among patients with cancer vs those without cancer. Risk vs those with no cancer was increased with younger age, and patients with...
Report Finds Uptake of Erdafitinib for Urothelial Cancer May Be Limited, Despite Positive Real-World Survival Data
The first bladder cancer drug targeting a cancer-driving gene mutation has been used relatively little despite its clear efficacy in a clinical trial, suggests a report published as a research letter by Nimgaonkar et al in JAMA Oncology. Researchers analyzed a large, nationwide database of cancer...
Next-Generation PARP1-Selective Inhibitor Offers Significant Benefits Over Older Predecessors in Treatment of Solid Tumors
The first-in-human, first-in-class trial of the next-generation PARP (poly [ADP-ribose] polymerase) 1–selective inhibitor AZD5305 suggests this drug may be a welcome advance over its U.S. Food and Drug Administration (FDA)-approved predecessors in the treatment of solid tumors with alterations in...
