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Showing 2301 - 2350Identifying Genetic Basis for Extraordinary Clinical Responses May Accelerate Development of New Therapies
Accelerating the discovery of targeted cancer therapies requires defining the targets present in individual tumors, and there are two main ways to do this, David B. Solit, MD, told participants at the inaugural OncoSET Symposium: Emerging Approaches to Precision Medicine in Chicago.1 The...
Abemaciclib Plus Fulvestrant Delays Breast Cancer Progression in MONARCH 2
In the treatment of metastatic estrogen receptor–positive breast cancer, a highly significant 45% reduction in progression was achieved with abemaciclib, combined with fulvestrant (Faslodex), in the global phase III MONARCH 2 trial, reported at the 2017 ASCO Annual Meeting by George W. Sledge, MD,...
Olaparib Improves Progression-Free Survival in BRCA-Associated Breast Cancer
The PARP INHIBITOR olaparib (Lynparza) improved progression-free survival in women with HER2-negative metastatic breast cancer that was either hormone receptor–positive or triple-negative in patients who had a germline BRCA mutation.1,2 These results of the international, randomized, open-label,...
Expert Point of View: Monika K. Krzyzanowska, MD, MPH
Formal discussant of the trial, Monika K. Krzyzanowska, MD, MPH, of the Princess Margaret Cancer Center in Toronto, Canada, commented on this trial assessing patient-reported outcomes for symptom monitoring. “This abstract is relevant to all of us, regardless of what cancers we treat or where we...
FDA Approves Aminolevulinic Acid Hydrochloride as an Optical Imaging Agent Indicated in Gliomas
On June 6, the U.S. Food and Drug Administration (FDA) approved aminolevulinic acid hydrochloride, known as ALA HCl (Gleolan), as an optical imaging agent indicated in patients with gliomas (suspected World Health Organization [WHO] Grades III or IV) for preoperative imaging, as an adjunct for the...
FDA Approves Daratumumab in Combination With Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has approved the use of daratumumab (Darzalex) in combination with pomalidomide (Pomalyst) and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide (Revlimid) and a...
Atezolizumab: Another Therapeutic Option for Patients With Previously Treated Non–Small Cell Lung Cancer
The OAK study—recently reported by Rittmeyer and colleagues and reviewed in this issue of The ASCO Post—is the first study to show patients with previously treated non–small cell lung cancer (NSCLC) treated with a humanized antibody (atezolizumab, Tecentriq) directed against the programmed cell...
FDA Broadens Ceritinib Indication
On May 26, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to ceritinib (Zykadia), a kinase inhibitor for patients with metastatic non–small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. In April...
Idelalisib Toxicities Appear to Be Immune-Related
Phosphoinositide 3-kinase (PI3K) inhibitors represent a highly active class of drug for the treatment of chronic lymphocytic leukemia (CLL). Idelalisib (Zydelig), a PI3K-delta inhibitor and the first PI3K inhibitor to be approved by the U.S. Food and Drug Administration (FDA) for CLL, has...
Venetoclax Achieves Durable and Deep Remissions in CLL
Preliminary study results suggest that venetoclax (Venclexta) plus rituximab (Rituxan) is a highly active combination in relapsed/refractory chronic lymphocytic leukemia (CLL), achieving durable responses and minimal residual disease negativity in previously treated patients. “The results of our...
FDA Approves Pembrolizumab for First Tissue/Site-Agnostic Indication
On May 23, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for adult and pediatric patients with unresectable or metastatic, microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed...
Making American Research Great Again
In the past 10 years, we have made remarkable advances in how we fight cancer. One of the most powerful new tools in our arsenal is cancer immunotherapy, which reawakens our own immune system to produce stunning results for many suffering from advanced cancer. Immunotherapy saved President Jimmy...
FDA Requests Removal of Oxymorphone Hydrochloride for Risks Related to Abuse
On June 8,the U.S. Food and Drug Administration (FDA) requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated oxymorphone hydrochloride (Opana ER), from the market. After careful consideration, the agency is seeking removal based on its concern that the benefits of the...
ASCO 2017: Research Suggests Possible New Treatment for EGFR-Positive Lung Cancer
Findings from a phase III clinical trial point to a potential new treatment for patients newly diagnosed with advanced, epidermal growth factor receptor (EGFR)-positive non–small cell lung cancer (NSCLC). Compared to the EGFR inhibitor gefitinib (Iressa), one of the standard targeted...
ASCO Announces CancerLinQ Partnerships With the FDA and the NCI
CancerLinQ®, ASCO’s big data initiative to rapidly improve the quality of cancer care, is partnering with the U.S. Food and Drug Administration (FDA) and the National Cancer Institute (NCI) to study the real-world use of newly approved cancer treatments and speed and strengthen the...
FDA Broadens Ceritinib Indication to Previously Untreated ALK-Positive Metastatic NSCLC
On May 26, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to ceritinib (Zykadia) for patients with metastatic non–small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. In April 2014,...
After Nearly 4 Decades of Research, W.K. Alfred Yung, MD, Sees a New Era Ahead for Advances in Brain Tumors
After he was not accepted into the University of Hong Kong, plan B for W.K. Alfred Yung, MD, was to leave his country and immigrate to the United States to attend the University of Minnesota in Minneapolis—a move he considers more exile than choice. Born on April 8, 1948, in Hong Kong, Dr. Yung...
Scott Gottlieb, MD, Receives Confirmation as FDA Commissioner
Statement by 2016–2017 ASCO President Daniel F. Hayes, MD, FACP, FASCO: “The American Society of Clinical Oncology (ASCO) congratulates Scott Gottlieb, MD, on his confirmation as Commissioner of the U.S. Food and Drug Administration (FDA). With more than 1.7 million new cancer diagnoses made in...
FDA Oncology Drug Approvals Granted Between August 2016 and May 18, 2017
Pembrolizumab (Keytruda), an anti–programmed cell death protein 1 (PD-1) therapy, received regular approval from the U.S. Food and Drug Administration (FDA) for patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing...
Former Vice President Joe Biden and Congressman Kevin Yoder Pledge Continued Support to Conquer Cancer
In a nearly hour-long address to more than 4,500 attendees at the 2017 Annual Meeting of the American Association for Cancer Research (AACR) on April 3, former Vice President Joe Biden lambasted President Trump’s proposed $5.8 billion budget cut to the National Institutes of Health (NIH) and...
Osimertinib in Metastatic EGFR T790M–Mutant NSCLC After EGFR Inhibitor Therapy
On March 30, 2017, osimertinib (Tagrisso) was granted regular approval for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M–mutant non–small cell lung cancer (NSCLC), as detected by a U.S. Food and Drug Administration (FDA)-approved test, who have progressed...
FDA Grants Priority Review to sBLA for Pembrolizumab in Recurrent or Advanced Gastric or GEJ Adenocarcinoma
The U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for pembrolizumab (Keytruda) seeking approval for treatment of patients with recurrent or advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have already...
New Immunotherapy Combinations Gain Ground in Advanced Melanoma, but Results Preliminary
Attention is focused among the cancer community on identifying the optimal immunotherapy combinations, with more than 800 ongoing trials of combination therapy. Two studies presented at the 2017 Annual Meeting of the American Association for Cancer Research (AACR) reported promising preliminary...
Pharmaceutical Companies Collaborate in NCCN Oncology Research Program
The National Comprehensive Cancer Network® (NCCN®) Oncology Research Program (ORP) has funded three studies in its first multi-industry collaborative research project, in which Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company are collaborating with NCCN to study combination...
New Chief of CHOP’s Cellular Therapy and Transplant Section
A leading pediatric oncologist at Children’s Hospital of Philadelphia (CHOP), Stephan Grupp, MD, PhD, was named Chief of the Section of Cellular Therapy and Transplant in the Hospital’s Division of Oncology. Dr. Grupp, who has researched and led groundbreaking clinical trials of an innovative...
Metastatic Urothelial Carcinoma: A Model Malignancy for Immune Checkpoint Blockade
Platinum-based combination chemotherapy became a mainstay of first-line treatment for metastatic urothelial cancer in the 1980s. With combination platinum-based regimens, 40% to 50% of patients achieve an objective response to treatment. However, aside from approximately 5% to 10% of patients who...
CheckMate 275 Supports FDA Approval of Nivolumab in Metastatic Urothelial Carcinoma After Platinum Therapy
As reported in The Lancet Oncology by Padmanee Sharma, MD, PhD, of MD Anderson Cancer Center, and colleagues, the phase II CheckMate 275 trial has shown that nivolumab (Opdivo) produced durable responses in patients with metastatic urothelial cancer who had received at least one prior...
FDA Grants Accelerated Approval to Pembrolizumab for First Tissue/Site-Agnostic Indication
On May 23, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for adult and pediatric patients with unresectable or metastatic, microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed ...
Abemaciclib Active in Metastatic Breast Cancer
In the single-arm phase II MONARCH 1 trial, the investigational cyclin-dependent kinase 4/6 (CDK4/6) inhibitor abemaciclib achieved an objective response in about 20% of heavily pretreated patients with metastatic hormone receptor–positive, HER2-negative breast cancer and a disease control rate of...
FDA OCE Launches Drug Information Soundcast in Clinical Oncology (DISCO)
The FDA Drug Information Soundcast in Clinical Oncology (DISCO) is a new podcast series from the U.S. Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE), covering new product approvals, emerging safety information for cancer treatments, and other current topics in cancer ...
FDA Approves Pembrolizumab for Advanced or Metastatic Urothelial Carcinoma
Today, the U.S. Food and Drug Administration (FDA) granted regular approval to pembrolizumab (Keytruda) for patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or...
FDA Approves Ribociclib/Letrozole Co‑Pack for Postmenopausal Patients With Advanced or Metastatic Breast Cancer
On May 8, the U.S. Food and Drug Administration (FDA) approved the copackaging of ribociclib (Kisqali) and letrozole (Femara) tablets for the treatment of hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in postmenopausal ...
FDA Approves Pembrolizumab as First-Line Combination Therapy With Pemetrexed and Carboplatin for Metastatic Nonsquamous NSCLC
On May 10, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda), an anti–programmed cell death protein 1 (PD-1) therapy, in combination with pemetrexed (Alimta) and carboplatin for the first-line treatment of metastatic nonsquamous non–small cell lung cancer...
FDA Grants Accelerated Approval to Avelumab for Urothelial Carcinoma
Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to avelumab (Bavencio) for patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant...
Blinatumomab ‘Takes a BiTE’ Out of Acute Lymphoblastic Leukemia
An investigational immunotherapy is improving outcomes in difficult-to-treat acute lymphoblastic leukemia (ALL) and showing promise in other cancers, as well. Blinatumomab (Blincyto), the first U.S. Food and Drug Administration (FDA)-approved bispecific T-cell engager (BiTE), has demonstrated...
Nivolumab/Ipilimumab Combination Improves Survival Over Ipilimumab Alone in Patients With Melanoma
The race is on to identify combinations of immune checkpoint inhibitors that can improve outcomes over the use of immune checkpoint inhibitor monotherapy. Updated results of the phase III CheckMate 067 trial found the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) improved survival in...
Introduction: CDK4/6 Inhibitors: Moving Beyond the Breast Cancer Setting
The novel mechanism of action of drugs that inhibit the cyclin D–dependent kinases CDK4 and CDK6 has prompted effective new treatment strategies. Although the bulk of the data supporting the use of selective CDK4/6 inhibitors is currently in breast cancer, patients with other tumor types are...
FDA Approves Durvalumab in Locally Advanced or Metastatic Urothelial Carcinoma
Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to durvalumab (Imfinzi) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease...
FDA Approves Brigatinib for Metastatic ALK-Positive Non–Small Cell Lung Cancer
On April 28, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to brigatinib (Alunbrig) for the treatment of patients with metastatic anaplastic lymphoma kinase (ALK)-positive non–small cell lung cancer (NSCLC) who have had disease progression on or are...
FDA Approves Midostaurin in Combination With Chemotherapy for Newly Diagnosed FLT3-Positive Acute Myeloid Leukemia
On April 28, 2017, the U.S. Food and Drug Administration (FDA) approved midostaurin (Rydapt) for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation–positive, as detected by an FDA-approved test, in combination with standard cytarabine and...
FDA Grants Lorlatinib Breakthrough Therapy Designation for ALK-Positive Metastatic Non–Small Cell Lung Cancer
On April 27, the investigational next-generation ALK/ROS1 tyrosine kinase inhibitor lorlatinib was granted Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non–small cell...
FDA Expands Approved Use of Regorafenib for Hepatocellular Carcinoma
The U.S. Food and Drug Administration (FDA) has expanded the approved use of regorafinib (Stivarga) to include treatment of patients with hepatocellular carcinoma who have been previously treated with the drug sorafenib (Nexavar). This is the first new FDA-approved treatment for liver cancer in...
FDA Takes Action Against 14 Companies for Selling Illegal Cancer Treatments
On April 25, the U.S. Food and Drug Administration (FDA) posted warning letters addressed to 14 U.S.-based companies illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat, or cure cancer. The products are marketed and sold without FDA approval, most commonly on ...
Trastuzumab Biosimilar Could Lead to Lower Health-Care Costs and Greater Drug Access for Patients With Metastatic Breast Cancer
The human epidermal growth factor receptor (HER) family consists of four members—epidermal growth factor receptor (EGFR), HER2, HER3, and HER4—all transmembrane receptor tyrosine kinases, which regulate cell growth and survival, differentiation, and migration, as well as other cellular responses.1 ...
Accelerating Pediatric Drug Development: Master Protocols May Be a Way to Go
Development of pediatric cancer drugs has long lagged behind adult drug development for two major reasons: The process is more difficult, and childhood cancer is rarer by far than adult cancer. These and other phenomena in pediatric oncology were the subject of a workshop held by the Friends of...
Monoclonal Antibody Therapy With Daratumumab in Multiple Myeloma: Expanding Therapeutic Horizons
The advent of successful monoclonal antibody therapy in the treatment of relapsed/refractory myeloma has dramatically improved the prognosis of patients for whom currently approved novel therapies have failed. In 2015, the approval of the combination of elotuzumab (Empliciti) with lenalidomide...
Updated Data on Treatment With Ibrutinib and Venetoclax in Patients With CLL/SLL
Long-term follow-up of treatment with ibrutinib (Imbruvica) in patients with previously untreated and treated chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) has shown high response rates that are durable. At 5 years, 89% of patients with treatment-naive and relapsed or...
Institute for Clinical Immuno-Oncology White Paper Highlights Challenges, Progress, and Priorities in Immunotherapy
Momentum around immunotherapies for cancer continues to build, but the high cost of these therapies places them at the center of debate about how best to define and measure value in cancer care. As these therapies are increasingly integrated into practice, all stakeholders—providers, patients,...
FDA Permits Marketing for Digital Pathology Solution for Primary Diagnostic Use
The U.S. Food and Drug Administration (FDA) has permitted marketing of the Philips IntelliSite Pathology Solution (PIPS, Philips Medical Systems Nederland B.V.), as an aid to pathologists to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin...
FDA Grants Atezolizumab Accelerated Approval as Initial Treatment for Some Advanced Bladder Cancers
On April 17, the U.S. Food and Drug Administration (FDA) granted accelerated approval to atezolizumab (Tecentriq) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin chemotherapy. Atezolizumab was previously approved for people...
