Search Results
Your search for ,Fda matches 3728 pages
Showing 3101 - 3150Omacetaxine Mepesuccinate Receives Full FDA Approval for CML
The U.S. Food and Drug Administration (FDA) has granted full approval to omacetaxine mepesuccinate (Synribo) for injection. The full approval was based on the final analysis of two phase II trials that evaluated the efficacy and tolerability data of omacetaxine. The agent received an accelerated...
Expert Point of View: Anas Younes, MD
This study provides proof of principle that different tumor types that express CD30 have a good chance of responding to anti-CD30 treatment. Brentuximab achieves good response rates of about 76% in mycosis fungoides and 85% in [anaplastic T-cell lymphoma]. In [mycosis fungoides] and cutaneous...
Promising Results Demonstrated for Brentuximab Vedotin in Cutaneous T-Cell Lymphoma
Phase II results suggest that brentuximab vedotin (Adcetris) has encouraging activity in CD30-positive cutaneous T-cell lymphomas and lymphoproliferative disorders, including mycosis fungoides, the most common type of cutaneous T-cell lymphoma. High levels of responses were achieved in a 48-patient ...
The Evolution of U.S. Cooperative Group Trials: Publicly Funded Cancer Research at a Crossroads
Over the past 5 decades, National Cancer Institute (NCI) Clinical Trials Cooperative Groups have played an enormous role in the fight against cancer, tackling a broad social agenda, including cancer prevention, quality-of-life issues for patients with cancer, and comparison of benefits among...
The FDA’s Bad Ad Program
INSIDE THE BLACK BOX is an occasional column providing insight into the FDA and its policies and procedures. In this installment, Robert Dean, MBA, Director, and Michael Sauers, Deputy Director, of Division II in the FDA’s Office of Prescription Drug Promotion discuss the FDA’s Bad Ad program. The...
Shaw T. Chen, MD, PhD, Joins Polaris Pharmaceuticals
Shaw T. Chen, MD, PhD, has been appointed Executive Vice-President of Regulatory Affairs at Polaris Pharmaceuticals, a subsidiary of Polaris Group. Dr. Chen had previously been with the U.S. Food & Drug Administration (FDA) for over 26 years in new drug development. Most recently he served as...
Study Shows Pathologic Complete Response to Neoadjuvant Therapy for Breast Cancer of Prognostic Value but Not for Use as Surrogate for Survival
Pathologic complete response to neoadjuvant therapy has been proposed as a surrogate endpoint for long-term clinical benefit in breast cancer. The U.S. Food and Drug Administration (FDA) established the international Collaborative Trials in Neoadjuvant Breast Cancer (CTNeoBC) working group to...
Electronic Cigarette Use and Smoking Among Adolescents
Use of e-cigarettes does not discourage, and may encourage, conventional cigarette use among U.S. adolescents.” This was the conclusion of a cross-sectional analysis of survey data from a representative sample of middle and high school students who completed the National Youth Tobacco Survey (NYTS) ...
A Conversation With Arie Belldegrun, MD, FACS, and Allan Pantuck, MD, MS, FACS
Cancer Immunotherapy What is the role of immunotherapy in the treatment of metastatic renal cell carcinoma? The harnessing of the immune system as an effective treatment for cancer was recently selected by the journal Science as the top scientific Breakthrough of the Year for 2013.1 With this...
Ethiodized Oil Approved for Imaging of Hepatocellular Carcinoma Tumors
The U.S. Food and Drug Administration has approved ethiodized oil injection (Lipiodol) for selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma. The agent received orphan drug designation for management of patients with known hepatocellular carcinoma ...
FDA Approves Ofatumumab for Previously Untreated Chronic Lymphocytic Leukemia
The U.S. Food and Drug Administration (FDA) has approved ofatumumab (Arzerra) injection in combination with chlorambucil (Leukeran) for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL), for whom fludarabine-based therapy is considered inappropriate. The...
FDA Grants Orphan Drug Designation for Anti-CD19 T-Cell Cancer Immunotherapy Product
Kite Pharma, Inc, announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development granted orphan drug designation for the company’s lead investigational therapy, an autologous engineered T-cell product that targets CD19 expression on B-cell malignancies, for the...
PALOMA-1 Trial Finds Palbociclib/Letrozole Doubles Progression-Free Survival in Metastatic Breast Cancer
First-line treatment with the combination of palbociclib plus letrozole extended progression-free survival by approximately 50% in patients with metastatic estrogen receptor–positive, HER2-negative breast cancer, according to final results of the PALOMA-1 trial, a randomized phase II study...
Learning More About Expanded Access Programs
The FDA and ASCO have collaborated to create an educational webinar to explain expanded access programs and to clarify the process to access investigational drugs outside a clinical trial. Although it is primarily intended for physicians, the webinar provides valuable information to anyone...
Quality Cancer Care
Ten years ago, at ASCO’s Annual Meeting, we were celebrating 40 Years of Quality Cancer Care. We have certainly seen many improvements in cancer care quality since then, especially in more effective agents and patient-centeredness care. When I joined ASCO in 1984, I never imagined that I would be...
SIDEBAR: FDA-Approved Drugs to Use as Single Agents or in Combination Chemotherapy
2014 Ceritinib for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, metastatic NSCLC with disease progression on or who are intolerant to crizotinib; mercaptopurine as a 20 mg/mL oral suspension for the treatment of acute lymphoblastic leukemia as part of a combination...
The Leukemia & Lymphoma Society Surpasses $1 Billion Investment in Blood Cancer Research
The Leukemia & Lymphoma Society (LLS) has announced that it has passed the $1 billion mark in research investment, a significant milestone in the cancer research landscape as the Society continues its 65-year pursuit of advancing breakthrough therapies, finding cures, and ensuring access to...
Ramucirumab for Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
On April 21, 2014, ramucirumab (Cyramza) was approved for use as a single agent in the treatment of patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with disease progression on or after prior treatment with fluoropyrimidine- or platinum-containing...
James P. Allison, PhD, Receives 2014 Canada Gairdner International Award
The Gairdner Foundation of Canada has named James P. Allison, PhD, for one of its 2014 Canada Gairdner International Awards. Dr. Allison is Chair and Professor of Immunology at The University of Texas MD Anderson Cancer Center in Houston. The honor, announced recently by the Gairdner Foundation,...
Project Data Sphere: Megadata in the Cloud Could Speed Clinical Trials Here on Earth
Project Data Sphere, which launched on April 8, is a “giant digital laboratory, an enormous library containing data about tens of thousands of patients and hundreds of clinical trials, all of which will be in the public domain,” said Martin J. Murphy, Jr, DMedSc, PhD, FASCO, Chief Executive Officer ...
Michael S. Gordon, MD, Named Medical Director for Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare
Michael S. Gordon, MD, has been named the new Medical Director for the Virginia G. Piper Cancer Center Clinical Trials program at Scottsdale Healthcare in Phoenix. Dr. Gordon will oversee the center’s phase I clinical trials program. Virginia G. Piper Cancer Center Clinical Trials at Scottsdale...
FDA Discourages Use of Laparoscopic Power Morcellation for Removal of Uterus or Uterine Fibroids
In a safety communication notice issued recently, the U.S. Food and Drug Administration (FDA) discouraged the use of laparoscopic power morcellation for the removal of the uterus (hysterectomy) or uterine fibroids (myomectomy) in women because, based on an analysis of currently available data, it...
Demanding More From Clinical Trials
“The function of the formal controlled clinical trial is to separate the relative handful of discoveries that prove to be true advances in therapy from a legion of false leads and unverifiable clinical impressions, and to delineate in a scientific way the extent of and the limitations that attend...
Cancer Chemotherapy Use During Pregnancy
INSIDE THE BLACK BOX is an occasional column providing insight into the FDA and its policies and procedures. In this installment, National Toxicology Program scientists Kembra L. Howdeshell, PhD, and Michael D. Shelby, PhD, discuss a recently completed monograph that reviews the published data on...
Volasertib Granted Orphan Drug Designation for Acute Myeloid Leukemia
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to volasertib for acute myeloid leukemia. Volasertib is currently being evaluated in a phase III clinical trial for the treatment of patients aged 65 or older, with previously untreated AML, who are ineligible for...
Supplemental New Drug Application Submitted for Ibrutinib in CLL
Pharmacyclics, Inc, and Janssen Biotech, Inc, have announced the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA), based on data from the randomized, multicenter, open-label phase III RESONATE study, a head-to-head comparison of single-agent ibrutinib ...
FDA Approves Mercaptopurine Oral Suspension for Acute Lymphoblastic Leukemia
On April 28, 2014, the U.S. Food and Drug Administration approved a 20 mg/mL oral suspension of mercaptopurine (Purixan) indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination regimen. Successive clinical trials have demonstrated that mercaptopurine ...
FDA Proposes to Extend Its Tobacco Authority to Additional Tobacco Products, Including E-Cigarettes
On April 24, 2014, as part of its implementation of the Family Smoking Prevention and Tobacco Control Act signed by the President in 2009, the U.S. Food and Drug Administration (FDA) proposed a new rule that would extend the agency’s tobacco authority to cover additional tobacco products. Products ...
FDA Approves First HPV Test for Primary Cervical Cancer Screening
The U.S. Food and Drug Administration (FDA) approved the first human papillomavirus (HPV) DNA test that can be used as a primary cervical cancer screening test for women aged 25 years and older. The test also can provide information about the patient’s risk for developing cervical cancer in the...
FDA Approves Siltuximab for Rare Castleman’s Disease
The U.S. Food and Drug Administration (FDA) has approved siltuximab (Sylvant injection) for the treatment of patients with multicentric Castleman’s disease who are human immunodeficiency virus (HIV)-negative and human herpes virus-8 (HHV-8)-negative. Multicentric Castleman’s disease is a rare...
FDA Approves Ceritinib for Late-Stage Lung Cancer
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to ceritinib (Zykadia) for patients with a metastatic anaplastic lymphoma kinase (ALK)-positive non–small cell lung cancer (NSCLC) who were previously treated with crizotinib (Xalkori). Ceritinib is an ALK tyrosine kinase...
Ceritinib Highly Active in Patients With ALK-Rearranged Advanced NSCLC
Non-small cell lung cancer (NSCLC) harboring ALK rearrangement is sensitive to the ALK inhibitor crizotinib (Xalkori), but resistance ultimately occurs. In a phase I study reported in The New England Journal of Medicine, Alice T. Shaw, MD, PhD, of Dana-Farber/Harvard Cancer Center, Boston, and...
Belinostat Moves Forward in Trials for Two Aggressive Cancers
In February, the U.S. Food and Drug Administration (FDA) granted belinostat (Beleodaq), a targeted histone deacetylase (HDAC) inhibitor, priority review status based on a pivotal phase II trial in peripheral T-cell lymphoma. Just 1 month later, researchers at the National Cancer Institute (NCI) in...
Expert Point of View: Daniel Petrylak, MD
This is an extremely important study,” said Daniel Petrylak, MD, Professor of Medicine and Urology at the Yale School of Medicine in New Haven, Connecticut. “This work needs to be replicated prospectively in a larger group of patients. Right now we have no way to select appropriate first-line...
Blood Test Can Identify Prostate Cancer Patients Who Are Not Likely to Respond to Enzalutamide
A simple blood test may be able to identify men with castration-resistant prostate cancer who will not respond to enzalutamide (Xtandi). The presence of the splice variant androgen receptor (AR) V7 in circulating tumor cells identified men who were unlikely to respond to enzalutamide and whose...
FDA Approves Ramucirumab for Stomach Cancer
The U.S. Food and Drug Administration (FDA) has approved ramucirumab (Cyramza) to treat patients with advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with disease progression on or after prior treatment with fluoropyrimidine- or platinum-containing chemotherapy....
ASCO Develops New Strategy to Increase Value in Cancer Care
Last January, ASCO held a leadership summit in Washington, DC, with representatives from the pharmaceutical industry, insurance payers, patient advocates, and physicians to address the skyrocketing costs of new drugs and technologies used in the diagnosis and treatment of cancer. Although costs are ...
Enthusiasm and Vision Guide the Head of FDA’s Oncology Office
In 2005, Richard Pazdur, MD, was named the FDA’s Director of the Office of Hematology and Oncology Products. By any measure, being arbiter of the nation’s oncology drug pipeline is a daunting prospect, but Dr. Pazdur sees it as an opportunity to encourage his talented staff to work for the greater ...
Nationally Renowned Surgeon and Researcher, John E. Niederhuber, MD, Relishes the Challenges That Lie Ahead
John E. Niederhuber, MD, was born and grew up in Steubenville, Ohio, a steel mill town located along the Ohio River. Dr. Niederhuber had a childhood interest in engineering and chemistry, but it was the town’s general practitioner who made a lasting impact on his career path. “He was an old-style...
FDA Approves Panitumumab Plus FOLFOX for Wild-Type KRAS Metastatic Colorectal Cancer
The U.S. Food and Drug Administration (FDA) has approved panitumumab (Vectibix) for use in combination with FOLFOX (fluorouracil, leucovorin, oxaliplatin) as first-line treatment in patients with wild-type KRAS (exon 2) metastatic colorectal cancer. This approval converts the accelerated...
FDA Approves Palonosetron Hydrochloride for Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients
The U.S. Food and Drug Administration (FDA) has approved palonosetron hydrochloride (Aloxi) injection for the prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy, in children aged 1...
Patients Benefit From Faster FDA Drug Approval Process
In an increasing spirit of cooperation, U.S. Food and Drug Administration (FDA) and several pharmaceutical companies are bringing to fruition the newest in a series of ways to expedite drug development and review. Breakthrough therapy is the designation instituted in 2012 by the FDA Safety and...
Mercaptopurine Oral Suspension for Acute Lymphoblastic Leukemia
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 April 28, 2014, an oral suspension of mercaptopurine (Purixan) ...
David Craig, PharmD, Named to FDA Advisory Committee
Moffitt Cancer Center recently announced that Clinical Pharmacist David Craig, PharmD, has been appointed to the U.S. Food and Drug Administration’s Anesthetic and Analgesic Drug Products Advisory Committee. Dr. Craig specializes in pain medicine and palliative care. The Anesthetic and Analgesic...
FDA Approves Radioactive Diagnostic Imaging Agent to Help Determine the Extent of Head and Neck Cancer in the Body
The U.S. Food and Drug Administration has 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. In 2013, tilmanocept...
FDA Approval of Siltuximab for Multicentric Castleman’s Disease
INSIDE THE BLACK BOX is an occasional column providing insight into the FDA and its policies and procedures. In this installment, FDA hematologist/oncologist Albert Deisseroth, MD, PhD, discusses the recent approval of siltuximab for patients with multicentric Castleman’s disease who are human...
Colorectal Cancer Screening Poised for Change
New screening modalities and the customization of the screening population could soon change the way that screening for colorectal cancer is done. At Digestive Disease Week 2014, the largest gathering of gastrointestinal disease specialists in the world, researchers presented data suggesting that...
FDA Approves Magnetic Resonance Contrast Agent for Evaluation of Breast Cancer
The U.S. Food and Drug Administration has approved a new indication for gadobutrol (Gadavist) injection for intravenous use with magnetic resonance imaging (MRI) of the breast to assess the presence and extent of malignant breast disease. The approval is based on priority review of two multicenter...
Expert Point of View: Cora N. Sternberg, MD, FACP
Despite the availability of hormonal therapy for the treatment of metastatic prostate cancer and the high response rates for these agents, most patients eventually experience progression to castration-resistant disease. “Multidisciplinary team approaches have contributed to the enormous progress...
Updated Information on Prostate Cancer Drugs: Enzalutamide, Orteronel, and Cixutumumab
Three separate studies of treatments for prostate cancer reported at the 2014 ASCO Annual Meeting in Chicago showed excellent, intermediate, and disappointing results. An update of the previously reported PREVAIL trial (see March 1 issue of The ASCO Post, page 1) was overwhelmingly positive for the ...
