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Showing 3151 - 3200Diagnostic Imaging Agent Approved for Use in Patients With Head and Neck Cancer
The U.S. Food and Drug Administration (FDA) recently approved a new use for technetium 99m tilmanocept (Lymphoseek Injection), a radioactive diagnostic imaging agent used to help doctors determine the extent to which squamous cell carcinoma has spread in the body’s head and neck region. Earlier...
FDA Launches 'OpenFDA' Initiative to Ease Access to Public Health Data
The U.S. Food and Drug Administration (FDA) has launched openFDA, a new initiative designed to make it easier for web developers, researchers, and the public to access large, important public health datasets collected by the Agency. In alignment with the recent Presidential Executive Order on Open...
Patricia M. LoRusso, DO, to Join Yale Cancer Center
Patricia M. LoRusso, DO, a leading expert on drug development through clinical trials, will join Yale Cancer Center in August as a Professor of Medicine and Associate Director of Innovative Medicine at Yale Cancer Center in New Haven, Connecticut. Dr. LoRusso brings more than 25 years of expertise...
First Tang Prize for Biopharmaceutical Science Awarded to James P. Allison, PhD, and Tasuku Honjo, MD, PhD
The first Tang Prize for Biopharmaceutical Science has been awarded to James P. Allison, PhD, Chair of Immunology at The University of Texas MD Anderson Cancer Center and Tasuku Honjo, MD, PhD, of Japan’s Kyoto University for their research leading to cancer immunotherapy. “Both scholars’...
Panitumumab Plus FOLFOX for KRAS Wild-Type Metastatic Colorectal Cancer
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Panitumumab (Vectibix) was recently approved by the U.S. Food and...
FDA Advisory Committee Votes Against Accelerated Approval for Olaparib in Ovarian Cancer
The U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 11 to 2 that current evidence from clinical studies does not support an accelerated approval for use of olaparib as a maintenance treatment for women with platinum-sensitive relapsed ovarian cancer who have...
'Impressive' Outcomes Achieved With Pembrolizumab in Advanced Melanoma
The latest bit of good news for the programmed death receptor-1 (PD-1)–targeting antibodies in advanced melanoma comes for pembrolizumab (MK-3475). While the results came from only a phase I study, they were among those chosen for presentation at an ASCO press briefing during the Annual Meeting....
Prostate Cancer Biomarkers: Improvement in Predicting Clinically Significant Disease
Prostate cancer will be diagnosed in 233,000 American men in 2014. It is one of the leading causes of death by a cancer (killing ~29,500 men annually).1 Hundreds of thousands of men undergo prostate biopsies each year, most for either benign disease or for a cancer that will never lead to their...
Belinostat for Relapsed/Refractory Peripheral T-Cell Lymphoma
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On July 3, 2014, belinostat (Beleodaq) was granted accelerated...
Progress in Differentiated Thyroid Cancer
Treatment of differentiated thyroid cancer has been slow to advance. Three decades lapsed between the description of the first differentiated thyroid cancer patient being cured by radioactive iodine in the 1940s1 and the report of the study that led to the approval of doxorubicin in the 1970s.2 The ...
FDA Drug Safety Communication: Docetaxel May Cause Symptoms of Alcohol Intoxication
The U.S. Food and Drug Administration (FDA) has issued a drug safety communication to health-care professionals warning that docetaxel contains ethanol, which may cause patients to experience intoxication during and after treatment. FDA is revising the labels of all docetaxel drug products to warn...
FDA Grants Breakthrough Therapy Designation to Blinatumomab for Acute Lymphoblastic Leukemia
The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to blinatumomab for adults with Philadelphia chromosome–negative relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL). Blinatumomab is an investigational bispecific T-cell engager antibody...
Investigational Immunotherapy Demonstrates Response in Patients With PD-L1–Positive Metastatic Bladder Cancer
The investigational immunotherapy agent MPDL3280A (also known as anti-PDL1) produced an overall response rate of 43% in a phase I study of patients previously treated for metastatic urothelial bladder cancer whose tumors were characterized as programmed death ligand 1 (PD-L1)-positive. Results of...
FDA Approves Belinostat for Relapsed or Refractory Peripheral T-Cell Lymphoma
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to belinostat (Beleodaq), a histone deacetylase inhibitor, for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma, a rare and fast-growing type of non-Hodgkin lymphoma (NHL). “This is the...
Orphan Drug Designation Granted for New Agent in Hepatocellular Carcinoma
CASI Pharmaceuticals, Inc, announced that its investigational agent ENMD-2076 has received orphan drug designation from the U.S. Food & Drug Administration (FDA) for the treatment of hepatocellular carcinoma. ENMD-2076 is an orally active Aurora A/angiogenic kinase inhibitor with a unique...
FDA Grants Breakthrough Therapy Designation to Investigational Chimeric Antigen Receptor Therapy for Relapsed/Refractory ALL
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy status to CTL019, an investigational chimeric antigen receptor (CAR) therapy for the treatment of pediatric and adult patients with relapsed/refractory acute lymphoblastic leukemia (ALL). The Breakthrough Therapy filing...
FDA Commissioner Margaret A. Hamburg’s Statement on the Surgeon General’s Call to Action to Prevent Skin Cancer
Each year, thousands of Americans are diagnosed with some form of skin cancer. The Surgeon General’s Call to Action to prevent skin cancer is important especially during these hot summer months when many of us spend extra time in the sun. Over the last few years, the FDA has taken a number of...
Surgeon General Call to Action to Prevent Skin Cancer
On July 29, 2014, the Surgeon General issued a Call to Action urging immediate action steps to prevent skin cancer. The report encourages increased awareness of the disease and calls for immediate and collaborative actions to reduce its risk. Nearly 5 million people are treated for skin cancer in...
AACR Issues Statement to Applaud FDA’s Actions
In a statement released earlier this month, the American Association for Cancer Research (AACR) applauded the U.S. Food and Drug Administration (FDA) for issuing its final guidance on “In Vitro Companion Diagnostic Devices” and proposing its “Framework for Regulatory Oversight of Laboratory...
FDA Takes Steps to Help Ensure the Reliability of Certain Diagnostic Tests
The U.S. Food and Drug Administration (FDA) recently took important steps to ensure that certain tests used by health-care professionals to help diagnose and treat patients provide accurate, consistent, and reliable results. First, the FDA is issuing a final guidance on the development, review, and ...
Book Excerpt: Family
I've witnessed incredible courage and zest for life among so many patients from so many walks of life—individuals committed to helping others in spite of their own adversity. Forty years ago, when survival for patients with multiple myeloma was a matter of months, I knew that every person I sat...
Patrick Soon-Shiong, MD, to Lead Providence Health Cancer Services and Bioinformatics
Providence Health & Services has announced that Patrick Soon-Shiong, MD, will serve as the health-care system’s new Global Director for Cancer Services and Bioinformatics. In this role, Dr. Soon-Shiong will work closely with oncology clinicians and researchers across the five-state Providence...
Ibrutinib in Previously Treated CLL and CLL With 17p Deletion
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On July 28, 2014, the approved use of ibrutinib (Imbruvica) in...
Idelalisib for Relapsed CLL in Combination With Rituximab and for Relapsed Follicular Lymphoma or Small Lymphocytic Lymphoma
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On July 23, 2014, idelalisib (Zydelig) was approved for use in...
FDA Approval of Ceritinib for the Treatment of ALK-Positive Non–Small Cell Lung Cancer
INSIDE THE BLACK BOX is an occasional column providing insight into the U.S. Food and Drug Administration (FDA) and its policies and procedures. In this installment, FDA oncologists Sean Khozin, MD, MPH, and Dikran Kazandjian, MD, discuss anaplastic lymphoma kinase (ALK)-positive non–small cell...
FDA Grants Bevacizumab Priority Review for Recurrent Platinum-Resistant Ovarian Cancer
The U.S. Food and Drug Administration (FDA) has accepted Genentech’s supplemental Biologics License Application and granted Priority Review for bevacizumab (Avastin) plus chemotherapy for the treatment of women with recurrent platinum-resistant ovarian cancer. “The majority of women with ovarian...
FDA Grants Bevacizumab Priority Review for Certain Types of Cervical Cancer
The U.S. Food and Drug Administration (FDA) has accepted Genentech’s supplemental Biologics License Application and granted Priority Review for bevacizumab (Avastin) plus chemotherapy in the treatment of women with persistent, recurrent, or metastatic cervical cancer. The designation of Priority...
Rational Strategies Are Advancing Combination Lymphoma Therapies
Rational strategies informed by knowledge of a drug’s molecular mechanisms are helping to bring new combinations of lymphoma therapies to the clinic, according to Anas Younes, MD, Chief of the Lymphoma Service at Memorial Sloan Kettering Cancer Center in New York. The Challenge of Too Many Drugs...
Precision Medicine: Precisely Where Are We Really?
Having attended ASCO Annual Meetings for almost 40 years, I believe that this year’s 50th anniversary celebration was one of the best ever. In many of the presentations and discussions, I experienced a sense of reality about the true state of cancer management that in previous years has sometimes...
Recent FDA Drug Approvals Foster Growing Treatment Armamentarium for Chronic Lymphocytic Leukemia and Rare B-Cell Lymphomas
Recent approvals announced by the U.S. Food and Drug Administration (FDA) have led to increased treatment options for managing several difficult-to-treat hematologic B-cell cancers. The newly approved drugs and/or their indications include the oral PI3K delta inhibitor idelalisib (Zydelig) for the...
How Pharmaceutical Companies Are Partnering With Patient Advocates to Ensure Access to Oncology Care
Thomas P. Sellers, MPA, has been a tireless advocate for patients’ rights for more than 20 years. A 15-year prostate cancer survivor and only child, Mr. Sellers said it was his mother’s death from lung cancer when she was 51, followed by the death of his father from glioblastoma multiforme that led ...
Bevacizumab in Persistent, Recurrent, or Metastatic Cervical Cancer
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On August 14, 2014, bevacizumab (Avastin) was approved for the...
ASCO Offers Input on 21st Century Cures PCAST White Paper
ASCO submitted a letter to the U.S. House Energy and Commerce Committee responding to the committee’s second white paper on its 21st Century Cures Initiative, 21st Century Cures: An Update on the President’s Council of Advisors on Science and Technology (PCAST) 2012 Report on Propelling ...
Bortezomib Retreatment in Multiple Myeloma
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On August 8, 2014, the approved use of bortezomib (Velcade) in...
FDA Approves Bortezomib Retreatment in Patients With Multiple Myeloma
The U.S. Food and Drug Administration has approved bortezomib (Velcade) for the retreatment of adult patients with multiple myeloma who had previously responded to bortezomib therapy and relapsed at least 6 months following completion of prior bortezomib treatment. The labeling update includes...
FDA Approves Bevacizumab for Aggressive and Late-Stage Cervical Cancer
The U.S. Food and Drug Administration (FDA) has approved the antiangiogenic agent bevacizumab (Avastin) for the treatment of persistent, recurrent, or metastatic cervical cancer. The new indication is approved for use in combination with paclitaxel and cisplatin or paclitaxel and topotecan. The FDA ...
FDA Grants Fast Track Designation to Novel JAK2 Inhibitor for the Treatment of Myelofibrosis
The U.S. Food and Drug Administration has granted Fast Track designation to pacritinib for the treatment of intermediate- and high-risk myelofibrosis, including patients with disease-related thrombocytopenia on other JAK2 therapy or patients who are intolerant to or whose symptoms are suboptimally...
FDA Approves First Noninvasive DNA Screening Test for Colorectal Cancer
The U.S. Food and Drug Administration (FDA) has approved Cologuard, the first stool-based colorectal screening test that detects the presence of red blood cells and DNA mutations that may indicate the presence of certain kinds of abnormal growths that may be cancers such as colon cancer or...
Oncology Practice: What Are the Factors Driving Change?
Clinical practice changes in response to new medical evidence, but not always immediately or all at once. So what else determines whether and how quickly practice changes in response to evidence, for instance, that a widely used drug is effective only in patients with a certain biomarker? In a new...
FDA Grants Priority Review to Lanreotide Injection for Gastroenteropancreatic Neuroendocrine Tumors
The U.S. Food and Drug Administration (FDA) has accepted and granted priority review to Ipsen’s supplemental New Drug Application (sNDA) for the somatostatin analog lanreotide (Somatuline Depot) 120 mg injection in the treatment of gastroenteropancreatic neuroendocrine tumors. The FDA designates...
Patient-Reported Outcomes in Hematology and Oncology Product Development
INSIDE THE BLACK BOX is an occasional column providing insight into the U.S. Food and Drug Administration (FDA) and its policies and procedures. In this installment, Virginia Kwitkowski, MS, RN, ACNP-BC, and Elektra Papadopoulos, MD, MPH, discuss FDA’s current approach to the review of study...
Angiogenesis in Ovarian Cancer: Are We Missing the Clinical Target?
Production of vascular endothelial growth factor (VEGF) is increased during normal ovulation, and can account for much of the reversible toxicity associated with ovarian hyperstimulation.1,2 We also have compelling data from multiple clinical trials to validate the importance of tumor-associated...
FDA Grants Fast Tract Designation to Investigational Combination Therapy In Metastatic Pancreatic Cancer
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Halozyme Therapeutics’ program investigating pegylated recombinant human hyaluronidase (PEGPH20) in combination with gemcitabine and albumin-bound paclitaxel (nab-paclitaxel [Abraxane]) for the treatment of patients...
Novel Immunotherapy for Ovarian Cancer Receives Fast Track Designation
The U.S. Food and Drug Administration (FDA) has granted fast track designation to the investigation of motolimod (VTX-2337) when administered in combination with pegylated liposomal doxorubicin for the treatment of women with ovarian cancer whose disease has progressed on or recurred after...
FDA Approves Pembrolizumab for Advanced Melanoma
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to the anti–PD-1 antibody pembrolizumab (Keytruda) for the treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs. Pembrolizumab is intended for use following treatment...
Top 5 Advances in Modern Oncology
1. Chemotherapy Cures Advanced Hodgkin Lymphoma In the first chemotherapy breakthrough for advanced cancer in adults, a four-drug combination chemotherapy regimen, called MOPP (mustargen/oncovin/procarbazine/prednisone), induced long-term remissions in over half of patients with aggressive Hodgkin ...
AACR 2014 Cancer Progress Report Call to Action: Prioritize Federal Funding for Biomedical Research
Last month, the American Association for Cancer Research (AACR) released its 2014 Cancer Progress Report: Transforming Lives Through Research, which highlights the quickening pace of drug development and approval, especially in molecularly targeted agents, that are leading to increased numbers of...
Clinical Trials Actively Recruiting Patients With Breast Cancer
The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies for people with breast cancer. The studies include phase I and II, interventional, and observational trials evaluating new therapies; diagnostic tools; genetic counseling; the association ...
On Being A Mentee and the Value of the Conquer Cancer Foundation’s Career Development Award
At the ASCO Annual Meeting in June, the Conquer Cancer Foundation presented the 2014 recipients of prestigious grants and awards, including the Young Investigator Award, Career Development Award, and the Advanced Clinical Research Award in Breast Cancer. In announcing the awards, Charles W. Penley, ...
Treating Sarcomas in 2014
In 2014, about 15,000 people in the United States will be diagnosed with some form of sarcoma, and of those, approximately 5,000 adults and children are expected to die of the disease. Sarcomas are a heterogeneous group of mesenchymal malignancies that have historically been difficult to diagnose...
