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Showing 601 - 650FDA Grants Accelerated Approval to Futibatinib for Previously Treated Patients With FGFR2-Mutated Cholangiocarcinoma
On September 30, the U.S. Food and Drug Administration (FDA) granted accelerated approval to futibatinib (Lytgobi) for adults with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or...
FDA Approves Biosimilar Bevacizumab-adcd for the Treatment of Six Types of Cancer
On September 28, the U.S. Food and Drug Administration (FDA) approved bevacizumab-adcd (Vegzelma), a biosimilar to bevacizumab (Avastin), for the treatment of six types of cancer: metastatic colorectal cancer; recurrent or metastatic nonsquamous non–small cell lung cancer (NSCLC); recurrent...
Patients With Multiple Myeloma May Face CAR T-Cell Shortages
From microchips to automobiles, people in the United States are experiencing shortages of all kinds of products, and oncology treatments are no exception. In particular, shortages related to chimeric antigen receptor (CAR) T-cell therapy have been reported, most acutely, for B-cell maturation...
Trastuzumab Deruxtecan for Advanced HER2-Mutant NSCLC
On August 11, 2022, fam-trastuzumab deruxtecan-nxki was granted accelerated approval for unresectable or metastatic non–small cell lung cancer (NSCLC) with tumors that have activating HER2 mutations, as detected by a U.S. Food and Drug Administration (FDA)-approved test and who have received a...
AACR Cancer Progress Report 2022 Shows Cancer Mortality Rates Continue to Decline, but Challenges Remain
Advances in more effective treatment and early detection diagnostics, coupled with reductions in smoking rates, have resulted in a 32% decline in cancer mortality in the United States since 1991, translating into nearly 3.5 million lives saved, according to the newly released American Association...
Selpercatinib Approved for Locally Advanced or Metastatic RET Fusion–Positive Solid Tumors
On September 21, the U.S. Food and Drug Administration (FDA) granted accelerated approval to selpercatinib (Retevmo) for adult patients with locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene fusion and disease progression on or following prior systemic...
FDA Approves Selpercatinib for Locally Advanced or Metastatic RET Fusion–Positive NSCLC
On September 21, the U.S. Food and Drug Administration (FDA) granted regular approval to selpercatinib (Retevmo) for adult patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) with a RET gene fusion (as detected by an FDA-approved test). The FDA also approved the Oncomine ...
Neoadjuvant Atezolizumab May Be Safe, Effective Option for Localized Non–Small Cell Lung Cancer
New data show that the immuno-oncology drug atezolizumab may be a safe and effective treatment for patients with stage IB to IIIB non–small cell lung cancer (NSCLC) prior to surgery, according to a study led by researchers with The Ohio State University Comprehensive Cancer Center–Arthur G. James...
FDA Approves Sodium Thiosulfate to Reduce the Risk of Ototoxicity Associated With Cisplatin
On September 20, the U.S. Food and Drug Administration (FDA) approved sodium thiosulfate (Pedmark) to reduce the risk of ototoxicity associated with cisplatin in pediatric patients aged 1 month and older with localized (nonmetastatic) solid tumors. Efficacy was evaluated in two multicenter,...
Neoadjuvant Cemiplimab in Patients With Stage II to IV Cutaneous Squamous Cell Carcinoma
In an international, multicenter phase II clinical trial, 63.3% of patients with stage II to IV cutaneous squamous cell carcinoma saw their tumors nearly or completely eradicated when treated with the anti–PD-1 agent cemiplimab-rwlc before surgery. The results were presented by Gross et al at the...
TROPiCS-02 Update: Sacituzumab Govitecan Improves Overall Survival in Previously Treated Patients With Hormone Receptor–Positive, HER2-Negative Breast Cancer
An overall survival benefit has now emerged for sacituzumab govitecan-hziy in patients with previously treated hormone receptor–positive/HER2-negative locally recurrent inoperable or metastatic breast cancer, according to a planned second interim analysis of the phase III TROPiCS-02 trial. These...
FDA Approves Eflapegrastim-xnst Injection for Chemotherapy-Induced Neutropenia
On September 9, the U.S. Food and Drug Administration (FDA) approved eflapegrastim-xnst injection (Rolvedon)—a long-acting granulocyte colony-stimulating factor (G-CSF) with a novel formulation—to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with...
Bispecific Antibodies and the Dawn of a New Era in Treatment of Multiple Myeloma
“I think the biggest innovations of the 21st century will be at the intersection of biology and technology. A new era is beginning!” —Steve Jobs Relapsed and refractory multiple myeloma remains a treatment challenge. Promising responses have been demonstrated with bispecific antibodies, with a...
ASCO Updated Guideline of Biomarkers in Metastatic Breast Cancer Supports PIK3CA, BRCA1/2, PD-L1 Testing
ASCO has issued a new practice guideline update on the use of biomarkers in the management of metastatic breast cancer.1 The updated guideline revisits recommendations from the 2015 guideline and addresses topics that have emerged since then in the move toward personalized medicine in metastatic...
Companion Diagnostic to Identify Patients With Endometrial Cancer Eligible for Pembrolizumab Therapy Approved by the FDA
On August 11, 2022, 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 companion diagnostic test to aid in identifying patients whose solid tumors are deficient in DNA ...
Wall Street Doesn’t Believe in This Target
March 2, 2009. Just published in the Journal of Clinical Investigation.1 And we even got the cover. Twists and turns of heat shock protein-90 (Hsp90), the chaperone, the evolutionary capacitor. Great name and important cancer target. People smiled when I talked about this at the Hsp90 conference....
Postmarketing Colitis Cases May Be Associated With Alpelisib Use
In a research letter in JAMA Oncology, Sullivan et al described details of postmarketing cases of noninfectious colitis in patients with breast cancer reported to the U.S. Food and Drug Administration that were considered possibly or probably related to alpelisib treatment. Key Findings A total of...
FDA Approves Durvalumab-Based Combination for Locally Advanced or Metastatic Biliary Tract Cancer
On September 2, the U.S. Food and Drug Administration (FDA) approved durvalumab (Imfinzi) in combination with gemcitabine and cisplatin for adult patients with locally advanced or metastatic biliary tract cancer. TOPAZ-1 Efficacy was evaluated in TOPAZ-1 (ClinicalTrials.gov identifier:...
FDA Approval of Pemigatinib and Update From the STAMPEDE Trial
On this episode, we’re covering the U.S. Food and Drug Administration (FDA) approval of pemigatinib for patients with myeloid or lymphoid neoplasms and an FGFR1 rearrangement. We’ll also discuss a long-term update from the STAMPEDE trial of radiotherapy in prostate cancer.
FDA Approves Cabozantinib for Patients With Previously Treated Radioactive Iodine–Refractory Differentiated Thyroid Cancer
On September 17, the U.S. Food and Drug Administration (FDA) approved cabozantinib (Cabometyx) for the treatment of adult and pediatric patients aged 12 years and older with locally advanced or metastatic differentiated thyroid cancer that has progressed following prior vascular endothelial growth...
FDA Approves Pemigatinib for Patients With Myeloid/Lymphoid Neoplasms and FGFR1 Rearrangement
On August 26, the U.S. Food and Drug Administration (FDA) approved pemigatinib (Pemazyre), a selective fibroblast growth factor receptor (FGFR) inhibitor, for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement. Myeloid/lymphoid neoplasms with...
MRI-Guided Ultrasound Focal Therapy May Delay or Avoid Prostatectomy or Radiotherapy in Patients With Intermediate-Risk Prostate Cancer
MRI-guided focused ultrasound focal therapy produced “a high degree of success” and “a low rate of genitourinary adverse events” when used to treat select patients with intermediate-grade prostate cancer, Behfar Ehdaie, MD, MPH, and colleagues reported in The Lancet Oncology.1 Dr. Ehdaie is...
FDA Approves Ibrutinib for Pediatric Patients With Chronic Graft-vs-Host Disease
On August 24, the U.S. Food and Drug Administration (FDA) approved ibrutinib (Imbruvica) for pediatric patients aged at least 1 year with chronic graft-vs-host disease after failure of one or more lines of systemic therapy. Formulations include capsules, tablets, and oral suspension. iMAGINE Trial...
FDA Approves First Cell-Based Gene Therapy to Treat Adult and Pediatric Patients With Beta-Thalassemia Who Require Regular Blood Transfusions
On August 17, the U.S. Food and Drug Administration (FDA) approved betibeglogene autotemcel (Zynteglo), the first cell-based gene therapy for the treatment of adult and pediatric patients with beta-thalassemia who require regular red blood cell transfusions. “[This] approval is an important...
FDA Grants Accelerated Approval to Trastuzumab Deruxtecan for HER2-Mutant NSCLC
On August 11, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) for adult patients with unresectable or metastatic non–small cell lung cancer (NSCLC) whose tumors have activating HER2 mutations, as detected by an...
FDA 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 ...
