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Showing 2351 - 2400Immunotherapy for Head and Neck Cancer: ‘The Fourth Modality Has Arrived’
“This is a big deal. This is going to change all of oncology, not just head and neck cancer,”1 Tanguy Seiwert, MD, remarked following a summary by Jeffrey Sosman, MD, on advances in immunotherapy for treating cancer.2 Dr. Sosman, Director of the Melanoma Program and Clinical Director of Cancer...
FDA Approves Lenalidomide as Maintenance Therapy for Patients With Multiple Myeloma Following Autologous Stem Cell Transplant
On February 22, the U.S. Food and Drug Administration (FDA) expanded the existing indication for lenalidomide (Revlimid) 10-mg capsules to include use for patients with multiple myeloma as maintenance therapy following autologous hematopoietic stem cell transplant. Clinical Trial Findings The...
ASCO and NCCN to Collaborate on Guidelines on Management of Immunotherapy Side Effects
ASCO and the National Comprehensive Cancer Network® (NCCN®) have announced a joint collaboration to publish practical clinical guidance on the management of side effects caused by immunotherapy. This novel collaboration aims to rapidly support improved quality of care for the growing number of...
Expert Point of View: Selina Luger, MD, Stephanie Lee, MD, and Gabriela Hobbs, MD
Speaking at the 2016 American Society of Hematology (ASH) Annual Meeting & Exposition, before the hold on pacritinib was lifted (in January 2017), Selina Luger, MD, of the University of Pennsylvania, Philadelphia, commented, “I think the U.S. Food and Drug Administration (FDA) needs to revisit ...
Pacritinib Reduces Spleen Volume in Myelofibrosis
The investigational drug pacritinib met the primary endpoint of the phase III PERSIST-2 trial in high-risk patients with myelofibrosis and thrombocytopenia. Treatment with the Janus kinase (JAK)1/2 inhibitor pacritinib achieved a significant reduction in spleen volume compared with best available...
FALCON Trial Informs the Evolving Role of Fulvestrant in Advanced Hormone Receptor–Positive Breast Cancer
Endocrine therapy for breast cancer has evolved over the years. Initial endocrine therapies consisted of ablative procedures (oophorectomy, adrenalectomy, and hypophysectomy). With the availability of pharmaceutical estrogens, progestins, and androgens, ablative procedure utilization begin to...
FDA Approves Telotristat Ethyl for Carcinoid Syndrome Diarrhea
On February 28, the U.S. Food and Drug Administration (FDA) approved telotristat ethyl (Xermelo) tablets in combination with somatostatin analog therapy for the treatment of adults with carcinoid syndrome diarrhea that somatostatin analog therapy alone has inadequately controlled. About...
Results From MONALEESA-2: Are All CDK4/6 Inhibitors Equal?
Hormone receptor–positive breast cancer is the most common subtype of breast cancer, and while endocrine therapy has long been a mainstay of therapy for these patients, treatment resistance ultimately develops. Therefore, better therapeutic approaches are needed. There are some data to suggest...
Researchers Use Cardiomyocytes to Create Index of Cardiotoxicity of Tyrosine Kinase Inhibitors
Researchers at the Stanford University School of Medicine used heart muscle cells made from stem cells to rank commonly used chemotherapy drugs based on their likelihood of causing lasting heart damage in patients. Tyrosine kinase inhibitors can be an effective treatment for many types of cancers, ...
Bright Future for Osimertinib in EGFR T790M–Positive Lung Cancer
The AURA3 study—reported by Mok and colleagues and reviewed in this issue of The ASCO Post—confirms the dramatic activity of osimertinib (Tagrisso) in patients with advanced epidermal growth factor receptor (EGFR)-mutant non–small cell lung cancer (NSCLC) and acquired resistance to prior EGFR...
Exploring the Opportunities and Challenges of Seamless Drug Development
The traditional three-phase clinical trial process for testing new drugs does not necessarily make sense when it comes to targeted therapies, according to many experts, including regulators, academic researchers, industry chief executive officers, and patient advocates alike. Instead of three...
FDA Approves Lenalidomide as Maintenance Therapy for Patients With Multiple Myeloma Following Autologous Stem Cell Transplant
On February 22, the U.S. Food and Drug Administration (FDA) expanded the existing indication for lenalidomide (Revlimid) 10 mg capsules to include use for patients with multiple myeloma as maintenance therapy following autologous hematopoietic stem cell transplant. The expanded indication makes...
Olaparib Meets Primary Endpoint in OlympiAD Trial in BRCA-Mutated Metastatic Breast Cancer
On February 17, positive results were announced from the phase III OlympiAD trial comparing olaparib (Lynparza) tablets to physician’s choice of a standard-of-care chemotherapy in the treatment of patients with HER2-negative metastatic breast cancer harboring germline BRCA1 or BRCA2...
2017 GU Cancers Symposium: Updated Efficacy and Tolerability of Durvalumab in Locally Advanced or Metastatic Urothelial Carcinoma
At the 2017 Genitourinary Cancers Symposium, Powles et al presented updated efficacy and safety data for durvalumab in patients with locally advanced or metastatic urothelial cancer (Abstract 286). Updated results from the phase I/II trial showed an objective response rate of 20.4% in all...
Exploring the Opportunities and Challenges of Seamless Drug Development
The traditional three-phase clinical trial process for testing new drugs does not necessarily make sense when it comes to targeted therapies, according to many experts, including regulators, academic researchers, industry chief executive officers, and patient advocates alike. Instead of three...
Edward Garon, MD, Receives $3.2 Million NIH Grant to Study Immunotherapy Responses in Lung Cancer
Edward Garon, MD, a member of the University of California, Los Angeles (UCLA) Jonsson Comprehensive Cancer Center and Associate Professor of Hematology and Oncology at the David Geffen School of Medicine, has received a 5-year, $3.2 million grant from the National Institutes of Health (NIH) to...
FDA Approves Ibrutinib in Relapsed/Refractory Marginal Zone Lymphoma
On January 19, the U.S. Food and Drug Administration (FDA) approved ibrutinib (Imbruvica) for the treatment of patients with marginal zone lymphoma who require systemic therapy and have received at least one prior anti–CD20-based therapy. Accelerated approval was granted for this indication based...
New Data on Prognostic Factors, Disease Detection, Drug Toxicities, and Treatment Adherence Presented at SABCS
The San Antonio Breast Cancer Symposium (SABCS) offers state-of-the-art information on all aspects of breast cancer biology, diagnosis, and treatment, drawing an international audience of more than 7,500 physicians, researchers, and other health-care professionals from over 90 countries. Through...
Managing Toxicities Associated With Immunotherapy for Lung Cancer
Understanding, anticipating, and managing the toxicities associated with immunotherapies for lung cancer are key to steps to safely using and achieving the most benefit from these new agents, according to Beth Eaby-Sandy, MSN, CRNP, OCN, a nurse practitioner at the University of Pennsylvania’s...
New Analysis of CheckMate 057: Search Continues for Predictors of Outcome With Nivolumab
Prognostic factors and tumor expression of programmed cell death ligand 1 (PD-L1) predict early mortality among patients with previously treated nonsquamous advanced non–small cell lung cancer (NSCLC) who receive nivolumab instead of docetaxel. But these features are not reliable for excluding...
Quality-of-Life Data From KEYNOTE-024: First-Line Pembrolizumab vs Chemotherapy in Advanced NSCLC
When used as first-line therapy for advanced non–small cell lung cancer (NSCLC), pembrolizumab (Keytruda) yields better health-related quality of life than platinum-based chemotherapy, suggest new data from the randomized phase III KEYNOTE-024 trial.1 After 15 weeks of treatment, changes in scores...
Clinical Trials Study the Role of Immunotherapy in the First-Line Setting of Non–Small Cell Lung Cancer
In 2016, the KEYNOTE-024 trial set the bar for first-line immunotherapy in non–small cell lung cancer (NSCLC). Trial results showed that pembrolizumab (Keytruda), an antibody to programmed cell death protein 1 (PD-1), reduced the risk of disease progression or death by 50% and the risk of death by...
FDA Accepts Two sBLAs for Pembrolizumab in Locally Advanced or Metastatic Urothelial Cancer
On February 3, the U.S. Food and Drug Administration (FDA) accepted for review two supplemental Biologics License Applications (sBLAs) for pembrolizumab (Keytruda) in patients with locally advanced or metastatic urothelial cancer. Specifically, the application for first-line use was accepted and...
Studies Advance the Use of PD-1 Blockade in Classical Hodgkin Lymphoma
Classical Hodgkin lymphoma is one of the malignancies most susceptible to treatment with monoclonal antibodies targeting the programmed cell death protein (PD-1). Nivolumab (Opdivo) has been approved by the U.S. Food and Drug Administration (FDA) for use in patients with relapsed/refractory...
Randomized Trial Demonstrates Benefit of Scalp-Cooling in Prevention of Chemotherapy-Induced Hair Loss
A scalp-cooling device was found safe and effective in preventing chemotherapy-induced hair loss in women undergoing adjuvant treatment for breast cancer in an interim analysis of the first prospective, randomized trial of a modern scalp-cooling system. The study was presented at the 2016 San...
FDA Approves Nivolumab in Locally Advanced or Metastatic Bladder Cancer
On February 2, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab (Opdivo) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have...
FDA Establishes Oncology Center of Excellence, Names Richard Pazdur, MD, Director
On January 19, 2017, U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, MD, issued the following statement: Today the U.S. Food and Drug Administration is establishing the Oncology Center of Excellence and appointing Richard Pazdur, MD, as its Director. This will make oncology...
Immunotherapy 2.0 Named Advance of the Year in ASCO's Report
A growing number of patients with cancer are benefiting from research advances in immunotherapy, leading ASCO to name immunotherapy as the Society's Advance of the Year for a second year in a row. Released today, Clinical Cancer Advances 2017: ASCO's Annual Report on Progress Against Cancer...
What Have We Got to Lose?
Tuesday morning was the regular time for the departmental meeting—an opportunity to discuss cases, troubleshoot, debrief, and expedite the necessary allied health referrals. As usual, patient cases were being discussed in alphabetical order of the attending oncologist. We were already three...
Rucaparib in Previously Treated BRCA Mutation–Associated Ovarian Cancer
On December 19, 2016, rucaparib (Rubraca) was granted accelerated approval for the treatment of patients with deleterious BRCA mutation–associated (germline or somatic) advanced ovarian cancer who have received two or more prior chemotherapy regimens.1,2 The U.S. Food and Drug Administration (FDA) ...
FDA Approves Extended-Release Morphine Product Formulated With Abuse-Deterrent Properties
On January 9, the U.S. Food and Drug Administration (FDA) approved morphine sulfate extended-release tablets with abuse-deterrent properties (Arymo ER), a C-II drug for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative...
Ibrutinib: A Potential Option for Chronic Graft-vs-Host Disease?
Currently, there is no U.S. Food and Drug Administration (FDA)-approved therapy for chronic graft-vs-host disease—a life-threatening consequence of stem cell or bone marrow transplant—that has not responded to corticosteroids, but this may be about to change. Ibrutinib (Imbruvica) achieved...
PARP Inhibitor Niraparib Yields ‘Unprecedented’ Results in Ovarian Cancer in Phase III Trial
The first phase III trial of an inhibitor of poly (ADP-ribose) polymerase (PARP) yielded unprecedented results in treating ovarian cancer. The trial was presented at the European Society for Medical Oncology (ESMO) in Copenhagen, Denmark, and electronically reported concurrently in The New England ...
Nivolumab in Squamous Cell Carcinoma of the Head and Neck in CheckMate 141: Game Not Over
Most patients with squamous cell carcinoma of the head and neck present with locally advanced disease. With combined-modality approaches, the chance of cure ranges from < 50% to up to 80%, depending on the site, stage, and other risk factors, such as human papillomavirus (HPV) status. When...
CAR T-Cell Therapy KTE-C19 Appears Successful in Aggressive B-Cell Lymphoma
Chimeric antigen receptor (CAR) T-cell therapy continues to have impressive showings in patients with aggressive hematologic malignancies and no other good treatment options. Interim results of the pivotal phase II ZUMA-1 trial, the first multicenter trial of the experimental CAR T-cell therapy...
Selected Abstracts From the 2016 San Antonio Breast Cancer Symposium
Each year, The ASCO Post asks Jame Abraham, MD, Director of the Breast Oncology Program at Taussig Cancer Institute and Co-Director of the Cleveland Clinic Comprehensive Breast Cancer Program, to give his picks for the most important research presented at the San Antonio Breast Cancer Symposium....
Oncology Drug Approvals in 2016
In 2016, the Office of Hematology and Oncology Products of the U.S. Food and Drug Administration (FDA) approved a number of new molecular entities, indications, and tests. The most notable were drug approvals in disease areas such as non–small cell lung cancer, myeloma, head and neck cancer, and...
FDA Approves Ibrutinib in Relapsed/Refractory Marginal Zone Lymphoma
The U.S. Food and Drug Administration (FDA) today approved ibrutinib (Imbruvica) for the treatment of patients with marginal zone lymphoma who require systemic therapy and have received at least one prior anti–CD20-based therapy. Accelerated approval was granted for this indication based on...
FDA Officially Establishes the Oncology Center of Excellence, Names Richard Pazdur, MD, as Director
Today, the U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, MD, issued the following statement: “Today the U.S. Food and Drug Administration is establishing the Oncology Center of Excellence (OCE) and appointing Richard Pazdur, MD, as its Director. This will make...
Institute for Clinical Immuno-Oncology White Paper Highlights the Challenges, Progress, and Priorities in Immunotherapy
While momentum around immunotherapies for cancer continues to build, 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,...
Tucatinib Shows Clinical Benefit in Phase I Trial in HER2-Positive Breast Cancer
Phase I clinical trial data published by Moulder-Thompson et al in Clinical Cancer Research reported that the investigational anticancer agent tucatinib (formerly ONT-380) showed 'notable activity' in the treatment of HER2-positive breast cancer with . The 50 women treated had disease...
FDA Approves Morphine Sulfate Extended-Release Tablets Formulated With Abuse-Deterrent Properties
On January 9, the U.S. Food and Drug Administration (FDA) approved morphine sulfate extended-release tablets formulated with abuse-deterrent properties (Arymo ER) for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative...
FDA Accepts sBLA and Grants Priority Review for Atezolizumab in Locally Advanced or Metastatic Urothelial Carcinoma
On January 9, the U.S. Food and Drug Administration (FDA) accepted the supplemental Biologics License Application (sBLA) and granted Priority Review for atezolizumab (Tecentriq) in the treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin...
FDA Grants Priority Review for the sNDA for Regorafenib in the Second-Line Systemic Treatment of Liver Cancer
On January 4, the U.S. Food and Drug Administration (FDA) granted Priority Review status for the supplemental New Drug Application (sNDA) for regorafenib (Stivarga) tablets for the second-line systemic treatment of patients with hepatocellular carcinoma in the United States. “Liver cancer is ...
Fulvestrant Plus Everolimus: New Second-Line Option for Postmenopausal Metastatic Breast Cancer
The addition of everolimus (Afinitor) to fulvestrant (Faslodex) doubled progression-free survival in postmenopausal women with hormone receptor–positive, HER2-negative metastatic breast cancer resistant to aromatase inhibitor therapy compared with fulvestrant plus placebo, according to the...
Oncology Organizations Applaud Passage of the 21st Century Cures Act
On Tuesday, December 13, President Obama signed into law the 21st Century Cures Act, landmark legislation designed to improve and accelerate the pace of biomedical research in the United States. ASCO Chief Executive Officer Clifford Hudis, MD, FACP, FASCO, attended the White House signing ceremony ...
FDA Permits Marketing of New Tissue Expander for Women Undergoing Breast Reconstruction Following Mastectomy
On December 21, the U.S. Food and Drug Administration (FDA) allowed marketing of a new tissue-expander system for soft-tissue expansion in two-stage breast reconstruction following mastectomy and in the treatment of underdeveloped breasts and soft-tissue deformities. A patient uses a dose...
Expert Point of View: Mikkael A. Sekeres, MD, MS
Mikkael A. Sekeres, MD, MS, Director of the Leukemia Program at the Cleveland Clinic Taussig Cancer Center in Ohio, commented on vadastuximab talirine in newly diagnosed acute myeloid leukemia (AML). He noted that the drug is similar to gemtuzumab ozogamicin, another antibody-drug conjugate that...
Weighing the Benefits and Risks of Medical Marijuana
Despite the fact that 28 states and the District of Columbia have enacted laws to permit the use of cannabis and cannabinoid-based drugs to treat medical conditions, including cancer and symptoms from its treatment, federal law prohibits physicians from prescribing marijuana to their patients,...
Accelerating Progress in the Treatment of Glioblastoma Multiforme
W.K. Alfred Yung, MD, has wanted a career in medicine since he was a high-school student and has spent nearly 4 decades fulfilling that dream, specifically in the research and treatment of one of the deadliest cancers, malignant brain tumor, especially glioblastoma multiforme, the most common...
