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Showing 2951 - 3000Ibrutinib Receives Third Breakthrough Therapy Designation from the FDA
Pharmacyclics, Inc, announced that the FDA has granted an additional Breakthrough Therapy Designation for the investigational oral agent ibrutinib as monotherapy for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma with deletion of the short arm of...
NCCN Clinical Practice Guidelines in Oncology: 2013 Updates
At the 18th Annual Conference of the National Comprehensive Cancer Network (NCCN), representatives of NCCN Guidelines panels presented two new sets of guidelines along with updates for several tumor types, summarized in this issue of The ASCO Post. New NCCN Guidelines for Survivorship “The...
On the Potential for Conflicts of Interest
In a recent issue of The ASCO Post, I counted 14 expert commentaries where the authority who wrote or was interviewed for the piece reported “no potential conflicts of interest.” I wondered how likely that was. We need to be clearer on the meaning of potential conflicts of interest. How often have...
How Is Sequestration Affecting Health Care?
The Budget Control Act of 2011, which calls for $1.2 trillion in federal funding cuts in national defense and nondefense programs, went into effect on March 1. The across-the-board cuts affect 21 agencies and programs directly involved in the health-care sector, including: Centers for Disease...
Sequestration's Impact on Cancer Care
On March 1, the deficit-budget mechanism known as sequestration took effect, triggering $85 billion in across-the-board cuts to most federal agencies over the remaining 7 months in fiscal year 2013. The total federal deficit reduction budget under the Budget Control Act of 2011 calls for $1.2...
Women at Increased Risk for Breast Cancer Should Be Offered Medications to Reduce Risk, Draft Recommendations Advise
Clinicians should engage in shared decision-making with women who are at increased risk of breast cancer about using medications, such as tamoxifen and raloxifene (Evista), to reduce risk, and should offer prescriptions to women considered at low risk for adverse effects from these medications,...
Utilizing the Power of Rapid Learning Health-care Systems to Improve Patient Care
Lynn Etheredge’s career in shaping national health-care and social policy spans more than 4 decades and four Presidential administrations. He was the lead analyst in the development of health insurance proposals for Medicare and Medicaid while working in the White House Office of Management and...
Peregrine Pharmaceuticals Reaches Agreement with FDA on Phase III Trial Design for Bavituximab in NSCLC
Peregrine Pharmaceuticals recently announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on a phase III registration trial design of the company’s lead clinical immunotherapeutic candidate bavituximab in second-line non–small cell lung cancer (NSCLC). The trial...
Radium-223 Dichloride Approved for Patients with Castration-resistant Prostate Cancer
On May 15, 2013, the U.S. Food and Drug Administration approved radium Ra 223 dichloride (Xofigo) for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases, and no known visceral metastatic disease. Radium-223 dichloride is an alpha-particle–emitting...
FDA Approves Expanded Use for Erlotinib, Companion Diagnostic to Detect Genetic Mutations in NSCLC
The FDA has approved erlotinib (Tarceva) for the first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations. This indication for erlotinib was approved...
Impressive Results Shown for Immune Checkpoint Inhibitors: Anti-PD1 and Anti-PD-L1 Antibodies
Antibody-mediated blockade of the programmed death 1 protein (PD-1) and its ligand (PD-L1) resulted in potent and durable tumor regression and prolonged stabilization of disease in patients with advanced solid tumors, according to early data on these drugs presented at the 2013 ASCO Annual Meeting. ...
SIDEBAR: Understanding the PD-1/PD-L1 Pathway and Its Promise
Tumors can be recognized by the immune system, but they have multiple mechanisms for evading eradication by the immune system. The tumor microenvironment suppresses the immune response, partly because tumors can express molecules that inhibit immune responses. The cancer clinical trials summarized...
Expert Genitourinary Oncologist's Drive Led Her from Baghdad to the United States
Born in Baghdad, Iraq, renowned prostate and bladder cancer specialist Maha H. Hussain, MD, FACP, Professor of Medicine and Urology at the University of Michigan Comprehensive Cancer Center, remembers that she always wanted to become a doctor. She had strong role models in three uncles who were...
FDA Clears Multicenter Trial of Treatment for Hair Loss Related to Chemotherapy
The FDA has approved initiation of a multicenter trial of the DigniCap System, a scalp-cooling device for chemotherapy-related hair loss. The trial is the second and final phase of study for the DigniCap System. A pilot study previously conducted by researchers at the University of California San...
FDA Approves Lenalidomide for Relapsed/Refractory Mantle Cell Lymphoma
The U.S. Food and Drug Administration has approved lenalidomide (Revlimid) for the treatment of patients with mantle cell lymphoma whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib (Velcade). Clinical Trial The approval was based on the results of...
Trametinib in Unresectable or Metastatic Melanoma with BRAF V600E or BRAF V600K Mutation
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 May 29, 2013, trametinib (Mekinist) was approved by...
Orphan Drug Status Granted for Novel Targeted Therapy to Treat Rare Hematologic Cancer
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to Stemline Therapeutics’ SL-401 for the treatment of blastic plasmacytoid dendritic cell neoplasm, a rare and aggressive hematologic malignancy for which there is no effective treatment. SL-401 also has Orphan Drug...
Dabrafenib for Unresectable or Metastatic Melanoma with BRAF V600E Mutation
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 May 29, 2013, dabrafenib (Tafinlar) was approved for ...
SGX942 Gets Fast Track Status for Treatment of Oral Mucositis
The FDA has granted fast track designation to the SGX942 development program for the treatment of oral mucositis as a result of radiation and/or chemotherapy treatment in patients with head and neck cancer. SGX942 is a fully synthetic, 5-amino acid peptide with high aqueous solubility and stability ...
FDA Approves Two Drugs, Companion Diagnostic Test for Advanced Skin Cancer
The U.S. Food and Drug Administration (FDA) recently approved two new drugs, dabrafenib (Tafinlar) and trametinib (Mekinist), for patients with advanced or unresectable melanoma. Dabrafenib, a BRAF inhibitor, is approved to treat patients with melanoma whose tumors express the BRAF V600E gene...
FDA Approves New Silicone Gel-filled Breast Implant
The FDA recently approved the MemoryShape Breast Implant for breast augmentation in women at least 22 years old and for breast reconstruction in women of any age. The MemoryShape Breast Implants are manufactured by Mentor Worldwide LLC. The FDA’s approval is based on 6 years of data from 955 women...
GM-CSF Boosts Survival Benefit of Ipilimumab in Metastatic Melanoma
For metastatic melanoma, the activity of ipilimumab can be boosted by the addition of granulocyte-macrophage colony-stimulating factor (GM-CSF, Leukine), according to a phase II study that found the combination improved overall survival, vs ipilimumab alone. The results were presented at the 2013...
SIDEBAR: Expect Questions about Programmed Death Receptors
In today’s high-tech, sci-fi–loving culture, “programmed death receptor” seems like a term apt to stir up public interest, particularly when those receptors are being “targeted” by “agents.” In this case, however, the agents are antibodies that target programmed death 1 (PD-1) receptor and disable...
'Spectacular' Results with Immunotherapies in Melanoma Galvanize the Oncology Community
In the News focuses on media reports that your patients may have questions about at their next visit. This continuing column will provide summaries of articles in the popular press that may prompt such questions, as well as comments from colleagues in the field. Much of the news about immunotherapy ...
Focus on the Society of Rhode Island Clinical Oncologists
Founded in 1994, just 1 year after ASCO launched the State/Regional Affiliate Program, the Society of Rhode Island Clinical Oncologists is one of ASCO’s oldest state affiliates. Like many other ASCO affiliates, the Providence-based group is facing a myriad of challenges, including ensuring...
Newly Approved Drugs and Indications
FDA has approved the following new drugs and/or indications in 2013: Denosumab (Xgeva subcutaneous injection) for giant cell tumor of bone. Lenalidomide (Revlimid capsules) for relapsed/refractory mantle cell lymphoma FDA approved. Trametinib (Mekinist tablets) for unresectable or metastatic...
Erlotinib in First-line Treatment of Metastatic NSCLC with EGFR Exon 19 Deletion or Exon 21 (L858R) Substitution
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 May 14, 2013, erlotinib (Tarceva) was approved for...
FDA Approves Denosumab to Treat Giant Cell Tumor of the Bone
The U.S. Food and Drug Administration (FDA) has expanded the approved use of denosumab (Xgeva) to treat adults and some adolescents with giant cell tumor of the bone, a rare and usually noncancerous tumor. Denosumab, which was granted orphan product designation, was reviewed under the FDA’s...
Investigational New Drug Application Filed for CFI-400945
Investigators from Princess Margaret Cancer Centre in Toronto and the University of California, Los Angeles, have submitted an Investigational New Drug (IND) application for CFI-400945, a novel drug candidate targeting the enzyme PLK4, which plays a crucial role in cell division. The news was...
ASCO Issues Progress Report on Blueprint for Cancer Research
ASCO has released a Progress Report on the gains made toward achieving goals set forth in its landmark 2011 report, Blueprint for Transforming Clinical and Translational Cancer Research. The ASCO Blueprint laid out an innovative roadmap for the clinical research system to capitalize on the new...
First Positive Trial of Heat Shock Protein 90 Inhibitor in Lung Cancer That Has Progressed after First-line Therapy
The investigational heat shock protein (Hsp)90 inhibitor ganetespib plus docetaxel extended overall survival compared with docetaxel alone as second-line therapy in patients with advanced non–small cell adenocarcinoma of the lung that had progressed on first-line therapy in the randomized phase II...
Expert Point of View: Howard A. Fine, MD and Albert Lai, MD, PhD
Howard A. Fine, MD, Chief of Hematology/Oncology at New York University Langone Medical Center and Director of the NYU Brain Tumor Center, served as formal discussant of the RTOG 0825 study at the Plenary Session. He noted the strong rationale for studying bevacizumab in glioblastoma, which is a...
FDA Approves Afatinib for Late-stage Lung Cancer
On July 12, 2013, the FDA approved the tyrosine kinase inhibitor afatinib (Gilotrif) for the first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors express epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations...
Denosumab in Adults and Skeletally Mature Adolescents with Giant Cell Tumor of Bone
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 June 13, 2013, denosumab (Xgeva) was approved for the ...
FDA Announces Decisions on New Tobacco Products
For the first time since the Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA the authority to regulate tobacco products, the agency has authorized the marketing of two new tobacco products and denied the marketing of four others through the substantial equivalence pathway....
FDA Grants Priority Review to Obinutuzumab in CLL and Pertuzumab in Neoadjuvant Therapy for HER2-positive Early-stage Breast Cancer
Two drugs were recently given Priority Review designation by FDA. Obinutuzumab (GA101) was granted Priority Review for the treatment of chronic lymphocytic leukemia, based on final stage 1 data from the pivotal CLL11 trial. The FDA confirmed the action date is December 20, 2013. FDA also granted...
New Research Presented in Breast, Gastric, Esophageal Cancers, Melanoma, and Multiple Myeloma, plus Supportive Care
Attendees at the ASCO Annual Meeting are faced with a major challenge of trying to attend as many important sessions as they can over a 4-day period. Our challenge is to feature the major news in The ASCO Post. In addition to our regular comprehensive coverage of key presentations, the following...
Roche Files for Cervical Cancer Primary Screening Indication for cobas HPV Test
Roche recently announced it has submitted a Premarket Approval (PMA) supplement to the FDA seeking the addition of a cervical cancer primary screening indication for the cobas HPV Test. Approval of the expanded indication would mean the cobas HPV Test could be used as the first-line test rather...
New Drug Application Submitted for Ibrutinib in the Treatment of Two B-cell Malignancies
Pharmacyclics, Inc, recently announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational oral Bruton’s tyrosine kinase inhibitor ibrutinib, for two relapsed/refractory B-cell malignancy indications: mantle cell lymphoma (MCL)...
Enzalutamide Monotherapy Highly Active in Patients with Prostate Cancer Who Have Had No Prior Hormone Therapy
Enzalutamide (Xtandi) monotherapy induced striking declines in prostate-specific antigen (PSA) in a majority of patients with hormone-naive prostate cancer in a phase II trial, and this oral agent appears to have little effect on bone mineral density. If these findings are confirmed in a phase III...
SIDEBAR: A Hot Season for Skin Cancer News, So Expect More Questions
An “alarming difference” in survival outcomes between young, non-Hispanic white males and females with primary invasive melanoma (see accompanying article) is one of several skin cancer–related study findings in the news this summer. Other studies have concerned the rising rates of melanoma among...
'Alarming Difference' in Survival Outcomes for Young White Men with Melanoma
An “alarming difference” in survival outcomes between young, non-Hispanic white males and females with primary invasive melanoma “highlights the urgent need for both behavioral interventions to promote early detection strategies in young men and further investigation of the biological basis for the ...
FDA Issues Warning on Rare but Serious Skin Reactions with Acetaminophen
The FDA recently issued a warning that acetaminophen has been associated with a risk of rare but serious skin reactions. These skin reactions, known as Stevens-Johnson Syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis, can be fatal. Serious Adverse Reactions FDA ...
Policy Update Aims to Advance Tobacco Cessation and Control Worldwide
In response to scientific advances and the evolving regulatory and policy environment, ASCO recently released an update to its 2003 policy statement on tobacco cessation and control. The statement reviews advancements that have been made since 2003 and outlines a refined set of recommendations...
Is Age Truly Relative in HER2-Positive Breast Cancer?
Breast cancer arising in younger women has increasingly become the subject of intense study, and often debate, over the past decade. Retrospective studies have illustrated that breast cancer in young women is more commonly an aggressive subtype (ie, triple-negative/basal-like, HER2-enriched),...
Afatinib as First-line Treatment for Metastatic NSCLC with EGFR Exon 19 Deletions or Exon 21 (L858R) Substitution Mutations
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 July 12, 2013, afatinib (Gilotrif) was approved for...
Diane E. Meier, MD: From Early Lessons in Critical Thinking to 'Palliative Care Everywhere'
Although the world is full of suffering, it is full also of the overcoming of it. —Helen Keller, Optimism, 1903 Shortly past 8:00 AM on July 1977, Diane E. Meier, MD, FACP, began the first day of her medical internship. Within minutes she would experience another first: the death of a patient...
Where Are We With ALK Inhibition in Lung Cancer?
The prospective phase III PROFILE 1007 study compared the ALK inhibitor crizotinib (Xalkori) to chemotherapy in patients with advanced non–small cell lung cancer (NSCLC) with ALK gene–rearranged tumors refractory to previous chemotherapy. The study showed a clear superiority for crizotinib in terms ...
FDA Invites Public Input on Menthol in Cigarettes
The U.S. Food and Drug Administration (FDA) has issued an Advance Notice of Proposed Rulemaking (ANPRM) seeking additional information to help the agency make informed decisions about menthol in cigarettes. Despite decades of work to reduce tobacco use in the United States, it continues to be the...
Molecular Tests and Precision Medicine: Not So Fast Now!
The era of the application of genomic, proteomic, and a host of other “omic” analyses to guide decision-making in the therapeutic selection of drugs and biologics is now a key part of cancer care. Medical practice is working to keep up with the scientific advances, evaluate them, and add a variety...
