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Showing 2251 - 2300FDA Approves First Companion Diagnostic Test to Simultaneously Screen for Multiple NSCLC Therapies
On June 22, the U.S. Food and Drug Administration (FDA) granted premarket approval to Thermo Fisher Scientific for the first next-generation sequencing–based test that simultaneously screens tumor samples for biomarkers associated with three FDA-approved therapies for non–small cell...
Priority Review Granted for Abemaciclib in the Treatment of Advanced Breast Cancer
On July 10, the U.S. Food and Drug Administration (FDA) accepted a new drug application (NDA) for abemaciclib, a cyclin-dependent kinase (CDK) 4/6 inhibitor, and gave the NDA a Priority Review designation. The NDA includes Eli Lilly and Company’s submission of abemaciclib for two indications: ...
FDA Accepts sNDA for Dasatinib in Pediatric Patients With Philadelphia Chromosome–Positive Chronic-Phase CML
On July 10, the U.S. Food and Drug Administration (FDA) accepted a supplemental new drug application (sNDA) to include an indication for dasatinib (Sprycel) to treat children with Philadelphia chromosome–positive chronic-phase chronic myeloid leukemia (CML), as well as a powder for oral...
FDA Grants 510(k) Clearance to Halcyon IMRT Treatment System
Varian Medical Systems has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Halcyon system, a new device for cancer treatment. Halcyon simplifies and enhances image-guided volumetric-intensity modulated radiotherapy (IMRT). “We are proud that Halcyon has now...
FDA Places Clinical Hold on Three Studies Evaluating Pembrolizumab in Multiple Myeloma
On July 5, Merck announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on KEYNOTE-183, KEYNOTE-185, and KEYNOTE-023, three combination studies of pembrolizumab (Keytruda), an anti–programmed cell death protein 1 (PD-1) therapy, in multiple myeloma. This...
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 Grants Marketing Approval to the Praxis Extended RAS Panel
On June 29, the U.S. Food and Drug Administration (FDA) granted marketing approval to the Praxis Extended RAS Panel, a next-generation sequencing test to detect certain genetic mutations in RAS genes in tumor samples of patients with metastatic colorectal cancer. The test is used to aid in the...
FDA Approves Panitumumab for Use in Wild-Type RAS Metastatic Colorectal Cancer
On June 30, 2017, the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for panitumumab (Vectibix) for patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic...
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 the monoclonal antibody 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 ...
Scalp Cooling to Prevent Chemotherapy-Induced Alopecia: Is It Now Ready for Prime Time?
In oncology, sometimes we forget about the small, everyday things that can significantly impact a patient’s life. When patients are explained the side effects of chemotherapy and chemotherapy-induced alopecia, most women will cry or become visibly upset. When a woman loses her hair, it represents...
Phase III CASCADE Trial of Vadastuximab Talirine in Front-Line AML Discontinued
On June 22, 2017, Seattle Genetics confirmed it discontinued the phase III CASCADE clinical trial of vadastuximab talirine (SGN-CD33A) in front-line older acute myeloid leukemia (AML) patients. Patient enrollment and treatment in all of its vadastuximab talirine clinical trials are suspended,...
Gideon M. Blumenthal, MD, Appointed OHOP Acting Deputy Office Director
Richard Pazdur, MD, Director of the Oncology Center of Excellence and Office of Hematology and Oncology Products (OHOP) Acting Director, has announced the appointment of Gideon M. Blumenthal, MD, as Acting Deputy Office Director of the OHOP at the U.S. Food and Drug Administration (FDA). Dr....
FDA Clears Expanded Use of Cooling Cap to Reduce Hair Loss During Chemotherapy
On July 3, the U.S. Food and Drug Administration (FDA) cleared the expanded use of a cooling cap, DigniCap Cooling System, to reduce hair loss during chemotherapy. This is the first cooling cap cleared by the agency for use in cancer patients with solid tumors. “We are pleased to expand the...
FDA Approves Panitumumab for Use in Wild-Type RAS Metastatic Colorectal Cancer
Today, the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for panitumumab (Vectibix) for patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic colorectal cancer...
FDA Allows Marketing of Test to Aid in the Detection of Certain Leukemias and Lymphomas
On June 29, the U.S. Food and Drug Administration (FDA) allowed marketing of ClearLLab Reagents (T1, T2, B1, B2, M), the first agency-authorized test for use with flow cytometry to aid in the detection of several leukemias and lymphomas, including chronic leukemia, acute leukemia, non-Hodgkin...
European Commission Expands Use of Ceritinib for First-Line Use in ALK-Positive Advanced NSCLC
On June 29, the European Commission approved expanding the use of ceritinib (Zykadia) to include the first-line treatment of patients with advanced non–small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)–positive. Approval follows a positive opinion granted...
ESMO World GI 2017: Pegilodecakin Plus FOLFOX in Advanced Pancreatic Cancer
Clinical data on an investigational immuno-oncology drug pegilodecakin (PEGylated human interleukin-10, also known as AM0010) was presented by Hecht et al at the ESMO 19th World Congress on Gastrointestinal Cancer in Barcelona, Spain (Abstract O-004). Pegilodecakin is being evaluated in an ongoing...
FDA Unveils Plan to Eliminate Orphan Designation Backlog
Today, the U.S. Food and Drug Administration (FDA) unveiled a strategic plan to eliminate the agency’s existing Orphan Drug designation request backlog and ensure continued timely response to all new requests for designation with firm deadlines. The agency’s Orphan Drug Modernization...
FDA Takes Steps to Increase Drug Competition to Improve Patient Access
On June 27, the U.S. Food and Drug Administration (FDA) took two new, important steps to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives. The agency published a list of off-patent, off-exclusivity branded drugs without approved generics, and ...
FDA Approves Betrixaban for the Prophylaxis of Venous Thromboembolism
On June 23, 2017, the U.S. Food and Drug Administration (FDA) approved betrixaban (Bevyxxa) for the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility...
ASCO Comments on Interchangeability of Biosimilars
ASCO submitted comments to the U.S. Food and Drug Administration (FDA) on the agency’s proposed guidance for industry on demonstrating the interchangeability of biosimilars with a reference product. The Society reiterated its strongly held position that physicians and patients should have the...
FDA Grants Regular Approval to Dabrafenib and Trametinib Combination for Metastatic NSCLC With BRAF V600E Mutation
On June 22, 2017, the U.S. Food and Drug Administration granted regular approvals to dabrafenib (Tafinlar) and trametinib (Mekinist) administered in combination for patients with metastatic non–small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test. These ...
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 the monoclonal antibody 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...
FDA Approves Rituximab Plus Hyaluronidase Combination for Treatment of Certain Hematologic Malignancies
On June 22, 2017, the U.S. Food and Drug Administration granted regular approval to the combination of rituximab and hyaluronidase human (Rituxan Hycela) for adult patients with follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia. The approval provides a...
Strides Being Made in Advanced Urothelial Cancer
According to Srikala S. Sridhar, MD, MSc, FRCPC, of the Princess Margaret Cancer Centre, Toronto, Canada, “It’s an exciting time in the field of urothelial cancer,” thanks to the emergence of new therapies such as the immune checkpoint inhibitors and other approaches that aim to improve both...
Identifying 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...
