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Showing 3051 - 3100Pathologic Complete Response as a Test Bed for Novel Therapies: Proceed—With Caution!
Pathologic complete response as assessed surgically after neoadjuvant treatment is being touted by some researchers as a stand-alone endpoint justifying early drug approval for breast cancer. They argue that it provides a more efficient means of testing the value of agents that might be useful in...
Nab-Paclitaxel in Metastatic Pancreas 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. Indication On September 6, paclitaxel protein-bound particles...
Cabozantinib in Medullary Thyroid Cancer: A Landscape-Shaping New Treatment
Medullary thyroid cancer is derived from parafollicular C cells in the thyroid gland. The disease is sporadic in about 75% of cases and hereditary in the remaining 25%.1 Oncogenic mutations in the gene for tyrosine kinase receptor rearranged during transfection (RET) are driver genetic alterations...
AACR Cancer Progress Report 2013 Highlights Critical Importance of Biomedical Research
On September 17, the American Association for Cancer Research (AACR) presented highlights of its 2013 Cancer Progress Report1 at the National Press Club in Washington, DC. AACR Chief Executive Officer Margaret Foti, PhD, MD (hc), opened the program with a double-edged message, first citing the...
'Master Protocol' Could Revolutionalize Trials in Lung Cancer, and Eventually Other Cancers
Cancer advocates and clinical trialists, for some time, have been proposing a radical change to the laborious drug development process—that industry, academia, funding sources, and other stakeholders actually pool their brain power and financial means and work together, not separately, to develop...
SIDEBAR: 2013 New Drug/Indication Approvals*
1. September 30, 2013: Pertuzumab (Perjeta) Accelerated approval in combination with trastuzumab and docetaxel for the neoadjuvant treatment of HER2-positive, locally advanced, inflammatory, or early-stage breast cancer. 2. September 6, 2013: Paclitaxel protein-bound particles (albumin-bound)...
A Look Ahead: How the FDA Is Adapting in the Era of Precision Medicine
Dubbed “Cancer Czar” by the media, Richard Pazdur, MD, Director of the U.S. Food and Drug Administration (FDA) Office of Hematology and Oncology Products, said he has the “best job in oncology, with a unique vantage point in cancer drug development.” An oncologist for more than 30 years—including...
FDA Announces Class-Wide Safety Labeling Changes for Long-Acting Opioid Analgesics to Combat Abuse
The U.S. Food and Drug Administration (FDA) announced class-wide safety labeling changes and new postmarketing study requirements for all extended-release and long-acting opioid analgesics intended to treat pain. “The FDA is invoking its authority to require safety labeling changes and postmarket...
FDA Grants Volasertib Breakthrough Therapy Designation in AML
Boehringer Ingelheim Pharmaceuticals, Inc, has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to volasertib, an investigational inhibitor of polo-like kinase (Plk), which being evaluated for the treatment of patients aged 65 or older with...
ASCO Submits Comments on Numerous Federal Initiatives
ASCO helps shape the regulatory framework in which oncologists practice by reviewing and commenting on a wide range of rules, guidelines, and system changes issued by federal agencies, including the U.S. Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), and...
Options for Management of Bone Health in Patients With Multiple Myeloma
Bone health is critical in patients with multiple myeloma, since up to 85% will suffer bone damage. Options for management include two FDA-approved bisphosphonates—pamidronate and zoledronic acid—and possibly the RANK-L inhibitor denosumab (Xgeva, investigational use). Importance of Supportive ...
New Strategies for Relapsed/Refractory Multiple Myeloma Explored
Although upfront therapy can achieve remission in multiple myeloma, most patients will ultimately relapse. Newer targeted therapies and genomic analysis are moving the management of relapsed/refractory multiple myeloma forward, according to Kenneth C. Anderson, MD, Director, Jerome Lipper Multiple...
Program Co-Directors Highlight Abstracts of Interest for the Upcoming 2013 San Antonio Breast Cancer Symposium
The Co-Directors of the 2013 CTRC-AACR San Antonio Breast Cancer Symposium, which will be held December 10–14, 2013, have highlighted what they consider to be the most important abstracts to be presented at the Symposium. In a telebriefing in advance of the December meeting, C. Kent Osborne, MD,...
Optimizing Anti-HER2 Treatment for Metastatic Breast Cancer in 2013
The good news about HER2-positive breast cancer is that recurrent disease is plummeting, owing to the impact of adjuvant trastuzumab [Herceptin]. Hopefully, first-line metastatic treatment is becoming a thing of the past,” said Harold Burstein, MD, PhD, of Dana-Farber Cancer Institute, Boston....
FDA Approves Obinutuzumab for Chronic Lymphocytic Leukemia
The U.S. Food and Drug Administration (FDA) has approved obinutuzumab (Gazyva) for use in combination with chlorambucil (Leukeran) to treat patients with previously untreated chronic lymphocytic leukemia (CLL). Obinutuzumab is the first drug with Breakthrough Therapy designation to receive FDA...
Omega-3
Common Name: Polyunsaturated fatty acids (PUFAs) Brand Names: Omegaven, Max-EPA The use of dietary supplements by patients with cancer has increased significantly over the past 2 decades despite insufficient evidence of safety and effectiveness. Finding reliable sources of information about...
SIDEBAR: Five Proposals for the FDA
At a forum convened by Friends of Cancer Research in September 2013, a panel of experts presented five proposals outlining how sponsors and FDA may be able to improve and expedite the process for the codevelopment and review of a companion diagnostic designed for use with a drug that has received...
FDA Hears Proposals on Codevelopment of Companion Diagnostics for Breakthrough Therapies
A companion diagnostic developed for use with a drug that has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) should automatically be eligible for priority review, according to an expert panel that presented this proposal and four others to the FDA in...
FDA Approves Transducer Array Layout System for Use in Patients With Recurrent Glioblastoma Multiforme
Novocure recently announced that it has received FDA approval for its NovoTAL (Transducer Array Layout) System through a Premarket Approval supplement. The NovoTAL System allows certified physicians to use the individual magnetic resonance imaging data of recurrent glioblastoma multiforme patients...
Pertuzumab in Neoadjuvant Treatment of HER2-Positive Early Breast 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. Indication On September 30, 2013, pertuzumab injection (Perjeta)...
FDA Announces Strategic Plan to Prevent Drug Shortages
The U.S. Food and Drug Administration (FDA) is taking two actions to further enhance the agency’s ongoing efforts to prevent and resolve drug shortages. The FDA has released a strategic plan called for in the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 to improve the...
Neoadjuvant Treatment of Early Breast Cancer
INSIDE THE BLACK BOX is an occasional column providing insight into the FDA and its policies and procedures. In this first installment, FDA Clinical Reviewers Laleh Amiri-Kordestani, MD, and Suparna Wedam, MD, discuss FDA’s recent approval of pertuzumab (Perjeta) for the neoadjuvant treatment of...
SIDEBAR: Brian J. Druker, MD, Discusses Ponatinib
In an interview with The ASCO Post following FDA’s recommendation that sales of ponatinib (Iclusig) be suspended, (see here) Brian J. Druker, MD, Director of Oregon Health & Science University Knight Cancer Institute and JELD-WEN Chair of Leukemia Research, had concerns about obtaining the drug ...
Investigational ALK Inhibitor Shows Promise in Patients With Crizotinib-Refractory, ALK-Positive NSCLC
Patients with non–small cell lung cancer (NSCLC) whose tumors have the ALK gene rearrangement usually respond to the drug crizotinib (Xalkori), with a median duration of response of approximately 10 months. In a study reported by Shirish Gadgeel, MD, of Karmanos Cancer Institute in Detroit, and...
FDA Grants Priority Review to Ramucirumab as a Potential Single-Agent Treatment for Advanced Gastric Cancer
The FDA has assigned Priority Review to the regulatory submission for ramucirumab as a single-agent treatment for advanced gastric cancer following disease progression after initial chemotherapy. Ramucirumab is a human monoclonal antibody that specifically blocks the vascular endothelial growth...
Sale of Ponatinib Suspended Due to Risk of Life-Threatening Blood Clots
The U.S. Food and Drug Administration (FDA) has asked the manufacturer of the tyrosine kinase inhibitor ponatinib (Iclusig) to suspend marketing and sales of the drug because of the risk of life-threatening blood clots and severe narrowing of blood vessels. Ariad Pharmaceuticals has agreed to...
FDA Approves First Extended-Release, Single-Entity Hydrocodone Product
The U.S. Food and Drug Administration (FDA) today approved hydrocodone bitartrate extended-release capsules (Zohydro ER) for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate. The drug, a Schedule...
Cediranib Achieves 'Groundbreaking' Results in Relapsed Ovarian Cancer
The investigational oral vascular endothelial growth factor (VEGF) inhibitor cediranib extended progression-free survival when given with platinum-based chemotherapy and improved overall survival when given as maintenance therapy in patients with recurrent ovarian cancer. Experts are hopeful that...
Strong Showing for Ado-Trastuzumab Emtansine in Advanced HER2-Positive Heavily Pretreated Breast Cancer
Results of the phase III TH3RESA trial show that the antibody-conjugate ado-trastuzumab emtansine (Kadcyla), formerly known as T-DM1, extends progression-free survival in women with advanced HER2-positive breast cancer that progressed on two or more previous HER2-directed therapies including...
FDA Grants Ofatumumab Breakthrough Therapy Designation for Previously Untreated CLL
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for ofatumumab (Arzerra) in combination with chlorambucil (Leukeran) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have not received prior treatment and are inappropriate for...
New Medical Device Treats Urinary Symptoms Related to Benign Prostatic Hyperplasia
The U.S. Food and Drug Administration has authorized the marketing of the UroLift system, a permanent implant to relieve low or blocked urine flow in men age 50 and older with benign prostatic hyperplasia. As men age, the prostate can become enlarged, also known as benign prostatic hyperplasia....
Has a New Standard of Care for Metastatic Pancreatic Cancer Been Established?
For a number of years following the approval of gemcitabine for advanced pancreatic cancer, one phase III clinical trial after the next failed to demonstrate a survival benefit of combination chemotherapy compared to gemcitabine alone. Even the one positive study from the mid-2000s—the PA.3 trial...
SIDEBAR: FDA Drug Approvals, 2013
Ibrutinib (Imbruvica) for mantle cell lymphoma Obinutuzumab (Gazyva) for chronic lymphocytic leukemia Pertuzumab (Perjeta) for breast cancer Paclitaxel protein-bound particles (Abraxane) for pancreatic adenocarcinoma Afatinib (Gilotrif) for non-small cell lung cancer, with Therascreen EGFR...
FDA Approves Ibrutinib for Mantle Cell Lymphoma
The U.S. Food and Drug Administration has approved ibrutinib (Imbruvica) to treat patients with mantle cell lymphoma, a rare and aggressive form of non-Hodgkin lymphoma representing about 6% of all non-Hodgkin lymphoma cases in the United States. By the time mantle cell lymphoma is diagnosed, it...
Early Evidence Supports Novel ALK Inhibitor in Patients with Non–Small Cell Lung Cancer With Brain Metastases
Identifying ALK rearrangements as a cancer target in patients with lung cancer led to the development and FDA approval of crizotinib (Xalkori) to treat ALK-positive non–small cell lung cancer (NSCLC). Several second-generation ALK inhibitors are in development, and these agents appear to work in...
Response-Guided Neoadjuvant Therapy for Breast Cancer: A Promising Model Warranting Additional Investigation
GeparTrio was an innovative phase III trial conducted by the German Breast Group, enrolling over 2,000 women with early breast cancer who were candidates for neoadjuvant chemotherapy. Patients with evidence of early response, defined as reduction in clinical tumor size by 50% or more, following two ...
Young Tobacco Consumers Frequently Use Products Other Than Cigarettes
“A substantial proportion of youth tobacco use occurs with products other than cigarettes, so monitoring and prevention of youth tobacco use needs to incorporate other products, including new and emerging products,” according to the Morbidity and Mortality Weekly Report, published by the Centers...
NIH Announces New Co-Chairs of Panel on Antiretroviral Guidelines
The National Institutes of Health recently announced several changes in leadership on the Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents. The panel, a working group of the NIH Office of AIDS Research Advisory Committee (OARAC), consists of...
Ibrutinib in Previously Treated Mantle 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. Indication On November 13, 2013, ibrutinib (Imbruvica) was granted...
The Quest to Optimize Personalized Therapies for Cancer
In the late 1980s, Brian J. Druker, MD, was investigating the BCR-ABL tyrosine kinase as a target for therapeutic intervention for chronic myeloid leukemia (CML) in a laboratory at Dana-Farber Cancer Institute in Boston. By 1993, Dr. Druker had moved to Oregon Health & Science University in...
National Cancer Policy Summit: Setting Priorities for the Next 3 Years
Welcome to the meeting we hold every 3 years to choose our next projects,” said John Mendelsohn, MD, Chair of the National Cancer Policy Forum and Director of the Khalifa Institute for Personalized Cancer Therapy at The University of Texas M.D. Anderson Cancer Center, Houston. “We have here a...
FDA Grants Regular Approval to Crizotinib for ALK-Positive NSCLC
The U.S. Food and Drug Administration (FDA) has granted regular approval for crizotinib (Xalkori) for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. The approval was based...
FDA Approves Sorafenib to Treat Late-Stage Differentiated Thyroid Cancer
The U.S. Food and Drug Administration recently expanded the approved uses of sorafenib (Nexavar) to treat late-stage differentiated thyroid cancer. The new indication is for patients with locally recurrent or metastatic, progressive differentiated thyroid cancer that no longer responds to...
Oncology Drug Dosing: Can an Optimal Dose Be Fine-Tuned for Each Patient?
ASCO Chief Medical Officer Richard L. Schilsky, MD, and other oncology drug experts presented a panel on drug dosing at a recent meeting, cosponsored by the Friends of Cancer Research and the Brookings Institution, in Washington, DC.1 The presentations made it clear that issues surrounding drug...
Clinical Cancer Advances 2013: ASCO's Annual Report on Progress Against Cancer
The Society has recently published Clinical Cancer Advances 2013: ASCO’s Annual Report on Progress Against Cancer, a comprehensive review of progress in clinical cancer research that has come to fruition in 2013. The report highlights advances across the entire continuum of cancer care, from...
Correctly Assessing Pain Progression and Quality-of-Life Deterioration in Metastatic Castration-Resistant Prostate Cancer
The therapeutic landscape for the treatment of castration-resistant prostate cancer has changed dramatically in the past 4 years, as five new agents affecting different aspects of the malignant process were proven to prolong life. The results are a great benefit to patients, but at the same time...
Breast Cancer Vaccines for Primary Prevention Move Toward Clinical Use
The first candidate vaccine to prevent recurrence of breast cancer entered clinical trials about 8 years ago, and since then, the idea of a vaccine for secondary prevention has gained traction; more such vaccines are now in development. But this fall, it was vaccines for primary prevention that had ...
Expert Point of View: Howard Hochster, MD
Addressing a presentation by Scott Kopetz, MD, PhD, at the 2013 Chemotherapy Foundation, Howard Hochster, MD, Yale University Cancer Center, New Haven, Connecticut, said he agrees with Dr. Kopetz about the need for expanded RAS testing. “Now we have two studies suggesting that tumors with all the...
Using Hyperthermia for Cancer Treatment: Proofs, Promises, and Uncertainties
With the headline, “Rare Cancer Treatments, Cleared by F.D.A. but Not Subject to Scrutiny,” a recent article in The New York Times reported that several medical centers were treating patients with cancer using a hyperthermia system that had received a Humanitarian Use Device approval from the U.S....
Activation of Innovative Lung Cancer Master Protocol Officially Announced, Enrollment to Begin in March
At a recent meeting in Washington, DC, Friends of Cancer Research and the Engelberg Center for Health Care Reform at the Brookings Institution officially announced activation of the Lung Cancer Master Protocol, a new research strategy that has the potential to hurdle or bypass known clinical trial...
