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Showing 3201 - 3250FDA 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...
Enzalutamide in Metastatic Castration-Resistant Prostate 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 September 10, 2014, the androgen receptor inhibitor...
Louis J. DeGennaro, PhD, Named President and Chief Executive Officer of The Leukemia & Lymphoma Society
The Leukemia & Lymphoma Society has announced that Louis J. DeGennaro, PhD, has been appointed as President and Chief Executive Officer, effective immediately. “Dr. DeGennaro has tirelessly dedicated himself for almost a decade of service to the Leukemia & Lymphoma Society mission and to...
ASCO, AACR Urge FDA to Regulate All Tobacco Products—Including E-Cigarettes
ASCO and the American Association for Cancer Research (AACR) sent a joint letter to the U.S. Food and Drug Administration (FDA) urging the agency to regulate electronic cigarettes, cigars, and all other tobacco products and to strengthen the proposed regulations for newly deemed products. The...
Advanced Robotic Technology Used to Remove Kidney Tumor in First-Time Outpatient Procedure
Keck Medical Center of the University of Southern California (USC) has become the first medical center in the world to use a new robotic technology in an outpatient procedure for a patient with kidney cancer. Urologic surgeons at the USC Institute of Urology, part of Keck Medicine of USC, used a...
Aldoxorubicin Receives FDA Orphan Drug Designations for Glioblastoma, Small Cell Lung Cancer, and Ovarian Cancer
The U.S. Food and Drug Administration has granted Orphan Drug Designations to aldoxorubicin in three indications: glioblastoma multiforme, small cell lung cancer, and ovarian cancer. Aldoxorubicin combines doxorubicin with a novel single-molecule linker that binds directly and specifically to...
FDA Grants Orphan Drug Designation to Bivalent Vaccine for Neuroblastoma
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to MabVax Therapeutics’ vaccine for the treatment of relapsed or recurrent high-risk neuroblastoma in remission or with limited residual disease after best available treatment. The bivalent vaccine is intended to elicit ...
Pathologic Complete Response: Understanding the Subtleties
In the neoadjuvant treatment of breast cancer, the importance of achieving a pathologic complete response (pCR) varies substantially by breast cancer subtype. Patients are increasingly interested in this outcome, but it means different things to different patients, according to two breast cancer...
Lymphatic Mapping Agent Receives Orphan Drug Designation for Head and Neck Cancers
Navidea Biopharmaceuticals, Inc, recently announced that technetium 99m tilmanocept (Lymphoseek Injection) has been granted Orphan Drug Designation by the U.S. Food & Drug Administration (FDA) for use in sentinel lymph node detection in patients with cancer of the head and neck. The designation ...
Exciting Highlights in Several Types of Lymphoma Presented at Best of ASCO
Antibody-drug conjugates are being tested against several types of lymphomas and for some of these agents, “activity is quite impressive,” Andrew M. Evens, DO, MSc, reported at the recent Best of ASCO meeting in Chicago. Dr. Evens, Professor of Medicine, Chief, Division of Hematology/Oncology, and...
Tough Questions About Health-Care Reform Put Economist in Hot Seat
Although diverse stakeholders agree that health reform is needed, there is little consensus on the specifics of that reform. Best of ASCO Seattle attendees put a number of pointed questions to health economist Rena Conti, PhD, of the University of Chicago, asking about thorny issues such as cost...
Health-Care Reform Is Changing the Oncology Landscape
Value-based health-care reform is happening. We have to get on board,” Rena Conti, PhD, a health economist at the University of Chicago, advised attendees of the Best of ASCO Seattle meeting. She discussed highlights from Annual Meeting sessions that addressed the impact of the Affordable Care Act...
Lenvatinib Receives Priority Review Designation for Advanced Thyroid Cancer
The U.S. Food and Drug Administration (FDA) has given Priority Review designation to the New Drug Application for lenvatinib mesylate as a treatment for progressive radioactive iodine–refractory differentiated thyroid cancer. Lenvatinib is an oral multiple receptor tyrosine kinase inhibitor with a...
E-Cigarettes Unhelpful in Smoking Cessation Among Patients With Cancer
In a new study of patients with cancer who smoke, those using e-cigarettes in addition to traditional cigarettes were more nicotine-dependent and equally or less likely to have quit smoking traditional cigarettes than nonusers.1 The rising use of e-cigarettes has raised many questions among...
Blinatumomab Receives FDA Priority Review Designation in Acute Lymphoblastic Leukemia
The U.S. Food and Drug Administration (FDA) has accepted for review Amgen’s Biologics License Application for blinatumomab for the treatment of adults with Philadelphia chromosome–negative relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL). As part of the acceptance, the FDA granted ...
FDA Approves Netupitant and Palonosetron Combination Capsule for Chemotherapy-Induced Nausea and Vomiting
The U.S. Food and Drug Administration (FDA) has approved a combination of netupitant and palonosetron (Akynzeo) to treat nausea and vomiting in patients undergoing cancer chemotherapy. The new drug, also known as NEPA, is a fixed-combination capsule comprised of two agents: oral palonosetron, which ...
FDA Approves Bortezomib Injection for Previously Untreated Patients With Mantle Cell Lymphoma
The U.S. Food and Drug Administration (FDA) has approved bortezomib (Velcade) injection for previously untreated patients with mantle cell lymphoma. This is the first treatment in the United States to be approved for use in previously untreated patients with mantle cell lymphoma. Bortezomib was...
Novel Agents May Address Endocrine Therapy Resistance
Progress has recently been swift in the development of new drugs to improve the response to hormone therapy in breast cancer, according to Hope S. Rugo, MD, Professor of Medicine and Director of Breast Oncology and Clinical Trials Education at the University of California, San Francisco, Helen...
Recent Reports and Perspectives on Chronic Lymphocytic Leukemia
Recent articles on developments and controversies in the treatment of chronic lymphocytic leukemia include the following features from The ASCO Post, which are also available at www.ascopost.com: “Recent FDA Approvals Foster Growing Treatment Armamentarium for Chronic Lymphocytic Leukemia and Rare ...
Expect Questions About Pertuzumab for HER2-Positive Breast Cancer
The 56.5-month overall survival for women with HER2-positive metastatic breast cancer receiving first-line treatment with pertuzumab (Perjeta) in combination with trastuzumab (Herceptin) and docetaxel in the CLEOPATRA trial represents a 15.7-month survival advantage for those receiving pertuzumab...
Impressive Survival Data for Women With HER2-Positive Breast Cancer Increase First-Line Use of Pertuzumab/Trastuzumab
"Impressive,” “outstanding,” and “unprecedented” are among the terms used to describe the 56.5-month overall survival for women with HER2-positive metastatic breast cancer receiving first-line treatment with pertuzumab (Perjeta) in combination with trastuzumab (Herceptin) and docetaxel in the...
Ramucirumab in Combination With Paclitaxel in Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
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 November 5, 2014, ramucirumab (Cyramza) was approved for use...
ASCO Endorses CAP/IASLC/AMP Guidelines for Molecular Testing of Patients With Non–Small Cell Lung Cancer
Personalized medicine is an established treatment concept for patients with advanced non–small cell lung cancer (NSCLC), and molecular characterization of tumors is crucial for choice of (first-line) therapy. As of right now, we have U.S. Food and Drug Administration (FDA)-approved drugs for two...
BRAF/MEK Inhibition in BRAF-Mutant Advanced Melanoma
Preliminary evidence of efficacy for BRAF inhibitors as monotherapy in advanced melanoma first emerged in 2009.1 Phase II and III trials rapidly ensued for vemurafenib (Zelboraf) and dabrafenib (Tafinlar), leading to U.S. Food and Drug Administration (FDA) approval in 2011. As a result of melanoma...
Expert Panel Explores Cost, Value, and Patient-Centered Care in Cancer Treatment
In assessing a cancer treatment, cost and value are two key factors. So how, the moderator asked, do they enter into your everyday decisions? Tanisha Carino, PhD, Executive Vice President of Avalere Health, was speaking to a clinical oncologist, a patient advocate, a pharma executive, and a health...
Expert Panels Offer Five Proposals to Address Challenges in Regulating, Implementing Next-Generation Sequencing
At the third annual Blueprint for Drug/Diagnostic Co-Development forum, cohosted by Friends of Cancer Research in Washington, DC, and the Alexandria Center for Life Science in New York, two panels tackled considerations in simultaneous development of drugs and companion diagnostics. Friends of...
