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Showing 3151 - 3200Supplemental 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 ...
Diagnostic 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...
