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Showing 1851 - 1900FDA Approves Lenvatinib for Unresectable Hepatocellular Carcinoma
Today, the U.S. Food and Drug Administration (FDA) approved lenvatinib capsules (Lenvima) for first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). REFLECT Trial Approval was based on the international, multicenter, randomized, open-label, noninferiority REFLECT trial ...
Navigating the ‘New Normal’: NCCN Summit Examines Access to High-Quality Cancer Care
It’s not just the leaps in development of precision medicines, the soaring costs, the new payment models, clinical trial designs, sources of data, and federal policies. It’s all of them plus the rapidity with which change is happening that makes this era of oncology exceptional. “I would say...
FDA Approves Mogamulizumab-kpkc for Two Rare Types of Non-Hodgkin Lymphoma
On August 8, the U.S. Food and Drug Administration approved mogamulizumab-kpkc (Poteligeo) injection for intravenous use in the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy. This approval provides a new...
Medical Marijuana: Research Not Anecdotes
For patients with cancer, marijuana may be valuable in controlling pain and chemotherapy-induced nausea and vomiting. Furthermore, it may have efficacy as an appetite stimulant. No randomized clinical trial has investigated the utility of whole-plant medical marijuana to alleviate these symptoms in ...
VB4-845 Granted Fast Track Designation by FDA for Treatment of Non–Muscle Invasive Bladder Cancer
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to VB4-845 for the treatment of bacillus Calmette-Guérin (BCG)–unresponsive, high-grade, non–muscle invasive bladder cancer. VB4-845 is currently being evaluated in a phase III registration...
Drug Combination Design for Multiple Myeloma Using an AI Platform
A multidisciplinary team of researchers from the National University of Singapore (NUS) has developed an artificial intelligence (AI) technology platform that could potentially change the way drug combinations are being designed, hence enabling doctors to determine the most effective drug...
FDA Grants Clearance of PowerLook Density Assessment for Digital Breast Tomosynthesis
iCAD has announced U.S. Food and Drug Administration (FDA) clearance of its artificial intelligence software program, PowerLook Density Assessment Version 3.4, which provides an automated method of determining breast density. The software is compatible with iCAD’s digital breast...
FDA Grants Breakthrough Device Designation for Cancer Detection Liquid Biopsy
PapGene, Inc, has announced their cancer detection test has received Breakthrough Device designation from the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA). The PapGene test is a multianalyte test that uses a combination of circulating tumor DNA...
FDA Grants Breakthrough Therapy Designation for Encorafenib Plus Binimetinib and Cetuximab in BRAF V600E–Mutant Metastatic Colorectal Cancer
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for encorafenib (Braftovi) in combination with binimetinib (Mektovi) and cetuximab (Erbitux) for the treatment of patients with BRAF V600E–mutant metastatic colorectal cancer (mCRC), as detected by...
FDA Grants 510(k) Clearance to SRT-100+ Superficial Radiation Therapy for Treating Nonmelanoma Skin Cancer and Keloids
Sensus Healthcare, Inc, a medical device company specializing in the noninvasive treatment of nonmelanoma skin cancers and keloids with image-guided superficial radiation therapy, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its new...
FDA Approves HPV Test for First-Line Cervical Cancer Screening
ON JULY 30, 2018, Roche announced approval by the U.S. Food and Drug Administration (FDA) of its cobas HPV Test in first-line screening for cervical cancer in women 25 years and older using cervical specimens collected in SurePath preservative fluid. The FDA first approved the cobas HPV test...
Meeting the Challenges of Immunotherapy-Related Toxicities
In 2011, the U.S. Food and Drug Administration (FDA) approved ipilimumab (Yervoy), an anticytotoxic T-lymphocyte– associated antigen 4 (CTLA-4), the first checkpoint inhibitor for the treatment of advanced melanoma.1 Since then, several more checkpoint inhibitors directed at both the programmed...
Encorafenib Plus Binimetinib in Unresectable or Metastatic Melanoma With BRAF Mutations
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. This past June, encorafenib (Braftovi) and binimetinib...
FDA Approves First Treatment for Rare Adrenal Tumors
On July 30, 2018, the U.S. Food and Drug Administration (FDA) approved iobenguane I 131 injection (Azedra) for intravenous use in the treatment of adults and adolescents aged 12 and older with unresectable pheochromocytoma or paraganglioma that have spread beyond the original tumor site and require ...
ASCO and Friends Submit Recommendations to FDA Aimed at Reducing Barriers to Clinical Trial Participation
ASCO and Friends of Cancer Research (Friends) have submitted recommended language to the U.S. Food and Drug Administration (FDA) for five guidance documents on ways to broaden eligibility criteria for cancer clinical trials. The recommendations are part of an ASCO...
Guidelines for Pediatric CAR T-Cell Therapy Developed
Almost 1 year after the U.S. Food and Drug Administration (FDA) approval of chimeric antigen receptor (CAR) T-cell therapy for children with acute lymphoblastic leukemia (ALL), researchers at The University of Texas MD Anderson Cancer Center and the Pediatric Acute Lung Injury and...
FDA Expands Ribociclib Indication in Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer
On July 18, 2018, the U.S. Food and Drug Administration (FDA) expanded the indication for ribociclib (Kisqali), in combination with an aromatase inhibitor for pre/perimenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based...
Durvalumab After Chemoradiation in Unresectable Stage III NSCLC
Early in 2018, durvalumab (Imfinzi) was approved for the treatment of unresectable stage III non–small cell lung cancer (NSCLC) that has not progressed following concurrent platinum-based chemotherapy and radiation therapy.1,2 Supporting Efficacy Data Approval was based on a planned interim...
FDA Approves Mogamulizumab-kpkc for Two Rare Types of Non-Hodgkin Lymphoma
Today, the U.S. Food and Drug Administration approved mogamulizumab-kpkc (Poteligeo) injection for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy. This approval provides a new...
FDA Warns of Increased Risk of Cancer Relapse With Long-Term Use of Azithromycin After Allogeneic Stem Cell Transplant
The U.S. Food and Drug Administration (FDA) is warning that the antibiotic azithromycin should not be given on a long-term basis to prevent the inflammatory lung condition bronchiolitis obliterans syndrome in patients with cancers of the blood or lymph nodes who undergo a donor stem cell...
Expert Point of View: Rajesh Lalla, DDS, PhD
COMMENTING ON the results of this trial of GC4419, Rajesh V. Lalla, DDS, PhD, President of the Multinational Association of Supportive Care in Cancer, said, “This study demonstrated this agent’s strong potential for the management of oral mucositis in patients receiving head and neck radiation...
Why Oncologists Should Decline to Participate in the Right to Try Act
ON MAY 30, 2018, President Donald J. Trump signed into law the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017.1 This law creates an additional and alternative pathway for patients with a “life-threatening disease or condition” to access...
FDA Grants Breakthrough Therapy Designation to Quizartinib for Relapsed/Refractory FLT3-ITD AML
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to quizartinib, an investigational FLT3 inhibitor, for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML). Breakthrough Therapy designation is designed to...
FDA Grants Breakthrough Therapy Designation to Lenvatinib Plus Pembrolizumab in Endometrial Carcinoma
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lenvatinib (Lenvima) in combination with pembrolizumab (Keytruda) for the potential treatment of patients with advanced and/or metastatic non–microsatellite instability high (MSI-H)/proficient...
FDA Approves Ivosidenib for Relapsed or Refractory Acute Myeloid Leukemia
On July 20, 2018, the U.S. Food and Drug Administration approved ivosidenib (Tibsovo) for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. Approval was based on an open-label, single-arm, multicenter...
Real-World Evidence Gaining Credibility and Practicality in Treatment Evaluation
In a Friends of Cancer Research (Friends) meeting devoted to real-world evidence, members of the cancer community generally agreed that its use has an increasingly important role to play in gathering the data necessary to test, evaluate, and bring new therapeutic agents to market. This Friends...
Abemaciclib as Initial Therapy for Hormone Receptor–Positive, HER2-Negative Advanced or Metastatic Breast Cancer
Early in 2018, abemaciclib (Verzenio) in combination with an aromatase inhibitor was approved as initial endocrine-based therapy for postmenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer.1,2 Supporting Efficacy Data Approval was based on findings in ...
FDA Grants Orphan Drug Designation to SRF231 for Treatment of Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to SRF231 for the treatment of patients with multiple myeloma. SRF231 is a fully human antibody that inhibits the activity of CD47, a protein overexpressed on many types of cancer cells, which prevents them from being...
FDA Approves Lusutrombopag for Thrombocytopenia in Adults With Chronic Liver Disease
Today, the U.S. Food and Drug Administration (FDA) approved lusutrombopag (Mulpleta) for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. L-PLUS 1 and L-PLUS 2 Approval was based on two randomized, double-blind, placebo-controlled...
FDA Approves Iobenguane I-131 for Rare Adrenal Gland Tumors
On July 30, the U.S. Food and Drug Administration (FDA) approved iobenguane I-131 (Azedra) injection for adult and pediatric patients (12 years and older) with iobenguane scan–positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma (PPGL) who require systemic...
FDA Grants Fast Track Designation to Galinpepimut-S in Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to galinpepimut-S for the treatment of multiple myeloma. Galinpepimut-S is licensed from Memorial Sloan Kettering Cancer Center and targets the Wilms tumor 1 (WT1) protein, which is present in an array of tumor types....
FDA Approves Magnetic Device System for Guiding Sentinel Lymph Node Biopsies in Patients With Breast Cancer
The U.S. Food and Drug Administration (FDA) recently approved a magnetic device system for guiding lymph node biopsies in patients with breast cancer undergoing mastectomy. The Magtrace and Sentimag Magnetic Localization System uses magnetic detection during sentinel lymph node biopsy procedures to ...
Pseudosophisticated Language and Needless Confusion?
I’ve been a loyal ASCO member since the early 1970s (aka “back in the day”) and wanted to share a growing pet peeve. I thought of attacking an individual author, but my sense tells me the source of my annoyance is really now a cultural problem and one that can only be fixed at the editor level....
Bevacizumab Plus Chemotherapy in Advanced Ovarian Cancer
ON JUNE 13, 2018, bevacizumab (Avastin) was granted approval for treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for stage III or IV disease after initial surgical resection1,2. The...
Pegfilgrastim-jmdb as Biosimilar to Pegfilgrastim to Decrease Risk of Infection During Cancer Treatment
On June 4, 2018, pegfilgrastim-jmdb (Fulphila) was approved as a biosimilar to pegfilgrastim (Neulasta) to decrease infection risk in patients with nonmyeloid cancer receiving myelosuppressive chemotherapy associated with a significant incidence of febrile neutropenia.1,2 Approval Basis Approval...
Opportunities, Issues, and Challenges for Biosimilars in Oncology
In an article published recently in TheNew England Journal of Medicine, Gary H. Lyman, MD, MPH, FACP, FRCP (Edin), FASCO, of Fred Hutchinson Cancer Research Center in Seattle, and colleagues reviewed opportunities, issues, and challenges posed by the advent of biosimilar medications, focusing on...
FDA Grants Breakthrough Therapy Designation for Atezolizumab/Bevacizumab Combination as First-Line Treatment for Advanced or Metastatic HCC
The U.S. Food and Drug Administration (FDA) recently granted Breakthrough Therapy designation for atezolizumab (Tecentriq) in combination with bevacizumab (Avastin) as a first-line treatment for people with advanced or metastatic hepatocellular carcinoma (HCC), the most common form of liver...
Olaparib for Germline BRCA-Mutated Metastatic Breast Cancer
EARLY IN 2018, olaparib tablets (Lynparza) were granted regular approval for treatment of patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting.1,2...
Abiraterone Plus Prednisone in High-Risk Metastatic Castration-Sensitive Prostate Cancer
EARLY IN 2018, abiraterone acetate tablets (Zytiga) in combination with prednisone were approved for the treatment of metastatic high-risk castration-sensitive prostate cancer.1,2 Supporting Efficacy Data APPROVAL WAS based on the findings of the phase III LATITUDE trial, in which 1,199 patients...
FDA Approves Enzalutamide for Castration-Resistant Prostate Cancer
ON JULY 13, 2018, the U.S. Food and Drug Administration (FDA) approved enzalutamide (Xtandi) for patients with castration-resistant prostate cancer (CRPC). This approval broadens the indicated patient population to include patients with either nonmetastatic CRPC or metastatic CRPC. Enzalutamide was ...
FDA Accepts BLA, Grants Priority Review for Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer
The U.S. Food and Drug Administration (FDA) recently accepted a biologics license application (BLA) for filing and granted Priority Review for sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer who previously received at least two prior therapies for...
FDA Approves Filgrastim Biosimilar Filgrastim-aafi
On July 20, the U.S. Food and Drug Administration (FDA) approved filgrastim-aafi (Nivestym), a biosimilar to filgrastim (Neupogen), for all eligible indications of the reference product. “The FDA approval of filgrastim-aafi marks an important step in helping expand access to critical...
FDA Approves Ivosidenib for IDH1-Mutated AML
Today, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. This is the first drug in its class (isocitrate dehydrogenase-1 [IDH1]...
In Case You Missed It: Short Takes on Current Cancer Research
It would be impossible to cover all of the important presentations from the 5,000-plus abstracts accepted for the 2018 ASCO Annual Meeting. In addition to our regular meeting coverage of the top news stories, the following highlights focus on novel investigational approaches to therapy for various...
Nivolumab Plus Low-Dose Ipilimumab Approved for Second-Line Treatment of MSI-H/dMMR Metastatic Colorectal Cancer
On July 11, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) plus low-dose ipilimumab (Yervoy) for the treatment of adult and pediatric patients aged 12 years and older with microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) metastatic colorectal...
FDA Expands Ribociclib Indication in Hormone Receptor–Positive, HER2-Negative Advanced or Metastatic Breast Cancer
Today, the U.S. Food and Drug Administration (FDA) expanded the indication for ribociclib (Kisqali) in combination with an aromatase inhibitor for premenopausal or perimenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer as initial...
FDA Grants Priority Review to sBLA for Pembrolizumab in Advanced Hepatocellular Carcinoma
The U.S. Food and Drug Administration (FDA) recently accepted and granted priority review for a new supplemental biologics license application (sBLA) seeking approval for pembrolizumab (Keytruda) as a second-line treatment for patients with advanced hepatocellular carcinoma. This sBLA, which is...
FDA Approves Enzalutamide for Castration-Resistant Prostate Cancer
On July 13, 2018, the U.S. Food and Drug Administration (FDA) approved enzalutamide (Xtandi) for patients with castration-resistant prostate cancer (CRPC). This approval broadens the indicated patient population to include patients with either nonmetastatic CRPC or metastatic CRPC. Enzalutamide was ...
Statement by FDA Commissioner on Opioid Access for Patients With Chronic and End-of-Life Pain
U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, recently issued the following statement. The opioid epidemic continues to take an emotional, physical, and financial toll on Americans. The FDA is committed to taking every possible step to address the many facets of this...
FDA Approves Nivolumab Plus Low-Dose Ipilimumab for Second-Line Treatment of MSI-H/dMMR Metastatic Colorectal Cancer
Today, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) plus low-dose ipilimumab (Yervoy) for the treatment of adult and pediatric patients aged 12 years and older with microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR)...
