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Showing 2351 - 2400ASCO Releases Position Statement on Access to Investigational Drugs
ASCO strongly supports increasing access to investigational new treatment options for patients with cancer, while raising serious concerns about recently proposed federal “right-to-try” legislation as well as state-enacted right-to-try laws. In a position statement released April 4, 2017, ASCO said ...
Next-Generation Genitourinary Oncology: Keeping One’s Powder Dry
There is a new yin-yang of management in genitourinary oncology, with the balance of opposing power focused among cancer cells, kinase inhibition, and lymphocyte function, representing a shift in the fashions of treatment somewhat away from chemotherapy. This linear progress has been complicated...
FDA Removes Risk Evaluation and Mitigation Strategy Requirements for Erythropoiesis-Stimulating Agents
On April 13, the U.S. Food and Drug Administration (FDA) removed the risk evaluation and mitigation strategy (REMS) requirements for the use of epoetin alfa and darbepoetin alfa to treat patients with anemia due to associated myelosuppressive chemotherapy. The Agency's announcement regarding...
FDA Grants Marketing Authorization for Ipsogen JAK2 RGQ PCR Kit to Detect JAK2 Genetic Mutations
The U.S. Food and Drug Administration (FDA) has granted marketing authorization to the ipsogen JAK2 RGQ PCR Kit, manufactured by QIAGEN GmbH, to detect mutations affecting the Janus tyrosine kinase 2 (JAK2) gene. This is the first FDA-authorized test intended to help physicians in evaluating...
Thomas E. Starzl, MD, PhD, ‘Father of Modern Transplantation,’ Dies at Age 90
Scientific and clinical pioneers have one thing in common: they move beyond their comfort zone and take calculated risks. One such pioneer, whose calculated risks gave hope to otherwise hopelessly ill people, was Thomas E. Starzl, MD, PhD, who performed the world’s first successful liver...
FDA Approves Maintenance Niraparib for Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
The U.S. Food and Drug Administration (FDA) has approved niraparib (Zejula) for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, whose tumors have achieved complete or partial response to platinum-based chemotherapy....
FDA Approves Avelumab for Metastatic Merkel Cell Carcinoma
The U.S. Food and Drug Administration (FDA) granted accelerated approval to avelumab (Bavencio) on March 23, 2017, for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma, including those who have not received prior chemotherapy. Avelumab is a...
AACR 2017: Adding the IDO-Pathway Inhibitor Indoximod to Pembrolizumab Improved Response Rate in Melanoma
Adding the investigational immunotherapy indoximod to the immunotherapy pembrolizumab (Keytruda) increased the proportion of patients with advanced melanoma who responded to treatment compared with previously reported response rates for pembrolizumab monotherapy, according to interim results from a ...
ASCO’s State of Cancer Care in America: 2017 Report Acknowledges Both the Progress Made in Oncology Care and the Challenges Ahead
Despite advances in cancer risk assessment, prevention, disease detection, drug development, and health-care delivery, which have led to unparalleled reductions in cancer incidence and mortality, access to affordable health care and increased administrative burdens placed on oncology practices...
AACR 2017: Combination of Nivolumab and Ipilimumab Improved Overall Survival in Advanced Melanoma
Among patients with advanced melanoma, those who received both nivolumab (Opdivo) and ipilimumab (Yervoy) had improved overall survival compared with those who received only ipilimumab, and appeared to have more favorable survival outcomes compared with those who received nivolumab, according to...
Palbociclib Receives FDA Approval and Expanded Indication for First-Line Metastatic Breast Cancer
On March 31, the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for a first-in-class cyclin-dependent kinase (CDK) 4/6 inhibitor, palbociclib (Ibrance), based on the results from the confirmatory phase III trial PALOMA-2. The FDA action converts the...
AACR 2017: Cancer Type and Mutation Identity Influenced Response to Neratinib in a Basket Clinical Trial
In the phase II SUMMIT clinical trial, the likelihood that a patient’s cancer responded to the investigational pan-HER–targeted therapeutic neratinib was influenced by both the cancer type and the identity of the gene mutation present in the cancer, according to results presented by...
FDA Grants Osimertinib Full Approval in Metastatic EGFR T790M Mutation–Positive NSCLC
On March 30, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to osimertinib (Tagrisso) for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation–positive non–small cell lung cancer (NSCLC), as detected by an...
Assessment of Immunohistochemistry Assays for PD-L1 Expression in NSCLC
In a study of four immunohistochemistry programmed cell death ligand 1 (PD-L1) expression assays registered with the U.S. Food and Drug Administration (FDA), scoring was highly concordant for expression in tumor cells but poorly concordant for scoring in immune cells in non–small cell lung...
FDA Approves Maintenance Niraparib for Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
The U.S. Food and Drug Administration (FDA) has approved niraparib (Zejula) for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, whose tumors have achieved complete or partial response to platinum-based chemotherapy....
Guidelines Planned on Management of Immunotherapy Side Effects: ASCO and NCCN to Collaborate on Development
Given the pace of advances in immunotherapy in recent years and physicians’ need to keep up with these developments, 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...
FDA Approves Avelumab for Metastatic Merkel Cell Carcinoma
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to avelumab (Bavencio) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma, including those who have not received prior chemotherapy. Avelumab is a programmed cell...
Pacritinib Update
An article in the March 10, 2017, issue of The ASCO Post reported on a presentation from the 2016 American Society of Hematology (ASH) Annual Meeting & Exposition, noting that the investigational drug pacritinib has been shown to reduce spleen volume in myelofibrosis. The article erroneously...
ASCO Addresses New Policies That Threaten Access to Opioids
Since the mid-2000s, medication and illicit drug abuse in the United Sates has steadily increased, creating what has now been termed an “opioid epidemic.” In response, Congress and the Bush and Obama Administrations have launched intervention and regulatory proposals to help turn the troubling...
ASCO Releases Its State of Cancer Care in America: 2017 Report
In a press briefing today on Capitol Hill, ASCO presented its fourth annual State of Cancer Care in America: 2017 report, which found that although the cancer care delivery system in the United States is undergoing profound changes to better meet the needs of cancer survivors, persistent hurdles...
FDA Approves Pembrolizumab for Relapsed or Refractory Classical Hodgkin Lymphoma in Adult and Pediatric Patients
The U.S. Food and Drug Administration (FDA) has approved pembrolizumab (Keytruda), an anti–PD-1 (programmed cell death protein 1) therapy, for the treatment of adult and pediatric patients who have refractory classical Hodgkin lymphoma or have relapsed after three or more prior lines of...
ASCO Honors Researchers and Scientists for Significant Advancements in Cancer Treatment and Care
ASCO and the Conquer Cancer Foundation of ASCO (CCF) have proudly announced the winners of ASCO's Special Awards, the Society's highest honors, and the CCF Women Who Conquer Cancer Mentorship Award. The recipients of these awards include researchers, patient advocates, and global oncology leaders...
FDA Approves Ribociclib as Initial Therapy for Hormone Receptor–Positive, HER2-Negative Advanced or Metastatic Breast Cancer
On March 13, 2017, the U.S. Food and Drug Administration (FDA) approved ribociclib (Kisqali), a cyclin-dependent kinase (CDK) 4/6 inhibitor, in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor–positive,...
Spotlight: ASCO Clinical Affairs
ASCO is working—through research, education, and promotion of the highest quality patient care—toward a world where cancer is prevented or cured, and every survivor is healthy. With the goal of ensuring that all patients receive the high-quality care they expect and deserve, ASCO is committed to...
Scripps Florida Collaboration Awarded $3.3 Million to Develop Next-Generation Breast Cancer Therapies
A pair of scientists from the Florida campus of The Scripps Research Institute (TSRI) have been awarded up to $3.3 million from the National Cancer Institute of the National Institutes of Health (NIH) to create the next generation of breast cancer treatments for the thousands of patients whose...
Immunotherapy 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...
