Search Results
Your search for ,Fda matches 3753 pages
Showing 3001 - 3050Newly 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...
Oncologists Speak Out Against the High Cost of Cancer Drugs
That the United States spends twice as much on health care than other industrialized countries—about $2.8 trillion in 2012—without reaping appreciably better outcomes1 is not news. The topic has been dissected on the front pages of leading newspapers for years and was the subject of the entire...
Role of Erlotinib in EGFR Wild-Type Lung Cancer
I welcomed Matthew Stenger’s Journal Spotlight on the TAILOR trial in the August 15 issue of The ASCO Post (“Docetaxel Superior to Erlotinib in Second-Line Treatment of Advanced Non–Small Cell Lung Cancer With Wild-Type EGFR”). The trial was recently published online in Lancet Oncology,1 and...
Dr. Julie Vose Finds the Best of Both Worlds—Patient Care and Cutting-Edge Research—in Academic Medicine
Julie M. Vose, MD, MBA, is the Neumann M. and Mildred E. Harris Professor and Chief of the Division of Hematology/Oncology at the University of Nebraska Medical Center. She grew up in Mitchell, South Dakota, a small town nestled on the banks of the James River. Mitchell is home to the Corn Palace,...
Enhanced Treatment, Surveillance Needed for Patients With BRAF-Mutant Melanoma to Prevent Secondary Cancers
Researchers at Moffitt Cancer Center suggest secondary cancers seen in melanoma patients who are being treated for a BRAF gene mutation may require new strategies, such as enhanced surveillance and combining BRAF inhibitor therapy with other inhibitors, especially as they become more widely used....
FDA Approves First Rapid Diagnostic Test to Detect Both HIV-1 Antigen and HIV-1/2 Antibodies
The U.S. Food and Drug Administration (FDA) approved the first rapid human immunodeficiency virus (HIV) test for the simultaneous detection of HIV-1 p24 antigen as well as antibodies to both HIV-1 and HIV-2 in human serum, plasma, and venous or fingerstick whole blood specimens. Approved for use as ...
Merkel Cell Carcinoma: Hints of Immune Mediation May Enhance Treatment Options
Merkel cell carcinoma is a rare but aggressive skin cancer with poor outcomes and suboptimal therapeutic options. With a 46% mortality rate, it is three times more lethal than melanoma, and its reported incidence is rising. “Merkel cell carcinoma is a nasty cancer and we have zero FDA-approved...
Access to and Appropriate Use of Oncology Drugs Called Into Question by ASCO Studies
Studies presented at this year’s ASCO Annual Meeting suggest that despite the wealth of amazing oncolytics on the market, drug shortages persist, drug substitutions are common, off-label use of drugs occurs frequently, and patients find their costs burdensome. Drug Shortage Persists The shortage of ...
Addressing the Key Clinical Questions in Advanced Melanoma
At the 3rd Annual World Cutaneous Malignancies Congress, in La Jolla, California, Steven J. O’Day, MD, Director of Clinical Research at the Beverly Hills Cancer Center and Adjunct Member of the John Wayne Cancer Institute, Los Angeles, addressed what he labeled the “key clinical questions” about...
FDA on CLL Drug Approval and Expanded Access
The ASCO Post article, “Ibrutinib CLL Trial: Where is the Equipoise?” published in May 2013, inaccurately conveyed that the Food and Drug Administration (FDA) requires an improvement in overall survival for chronic lymphocytic leukemia (CLL) drug approval and opposes allowing crossover in the...
Clinical Trials, Crossover, and Clinical Equipoise: An Advocate's Perspective
In a previous issue of The ASCO Post, Dr. Susan O’Brien wrote, “It is my understanding that the FDA strongly opposed allowing crossover [in the RESONATE trial]. I presume that is because the FDA also wants to see if there is a survival advantage.”1 The lack of crossover seems a valid concern to me...
Clinical Trials, Crossover, and Clinical Equipoise: A Patient's Perspective
I am writing with regard to two articles on the ethical imperative of clinical equipoise written by Susan O’Brien, MD, and Stephen J. Schuster, MD, and published recently in The ASCO Post.1,2 I was a victim of Pharmacyclics’ policies during one of their randomized ibrutinib trials (PCI-32765)...
The Trials and Tribulations of a Revolutionary Cancer Drug
A modest brass plaque above a booth in the Eagle Pub in Cambridge, notes, “On this spot, on February 28, 1953, Francis Crick and James Watson declared the discovery of DNA with these words: ‘We have discoverewd the secret of life.’” Announcing a major scientific advance over a pint of ale is a far...
Sorafenib Granted Priority Review for Differentiated Thyroid Cancer
Bayer HealthCare and Onyx Pharmaceuticals recently announced that the FDA has granted priority review designation to the supplemental new drug application of sorafenib (Nexavar) tablets for the treatment of locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer....
FDA Approves Mechlorethamine Gel for Cutaneous T-Cell Lymphoma
Ceptaris Therapeutics, Inc, recently announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for the orphan drug mechlorethamine gel (Valchlor) for the topical treatment of stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (CTCL) in patients who have ...
Prescribing of Off-Label Chemotherapy Is Common, and Most Off-Label Drug Use Meets NCCN Compendium Criteria
Off-label prescribing of drugs remains common in oncology, but about two-thirds of off-label prescribing is consistent with the National Comprehensive Care Network (NCCN) compendium, according to a study1 reviewed at the Best of ASCO® ’13 meeting in Chicago by Monika K. Krzyzanowska, MD, MPH,...
Pomalidomide In Patients With Disease Progression Who Are Refractory to Bortezomib and Lenalidomide
The second-generation immunomodulatory drug pomalidomide (Pomalyst) “has shown impressive results in patients with multiple myeloma who are refractory to lenalidomide [Revlimid] and bortezomib [Velcade],” according to a review of clinical data leading to the drug’s approval by the FDA. In February, ...
SIDEBAR: Expect Questions About E-Cigarettes
E-cigarettes are in the news, in advertising, and in stores, and because their public use is still largely unregulated, they may be in your face. Being prepared to answer questions about their use may help patients make wise decisions. What are e-cigarettes? Electronic cigarettes or e-cigarettes, ...
What You Need to Know About E-Cigarettes
“I’ve seen a lot of puzzled people,” Alexander V. Prokhorov, MD, PhD, said, referring to people who see others using electronic or e-cigarettes. That puzzlement can go beyond wondering why people are smoking in public places and whether they are breaking the law, or just being annoying, to...
Straight Talk: The Future of Medical and Health Research
Nearly 200 scientists and stakeholders in the research community attended Research!America’s National Health Research Forum on September 12, at the Newseum’s Knight Conference Center in Washington, DC. Research!America’s President and CEO, Mary Woolley, opened the program. “The theme for this...
Radium-223 and Beyond in Metastatic Castration-Resistant Prostate Cancer
Metastasis to bone is the hallmark of prostate cancer and a major source of disease-related morbidity and mortality. In addition to prostate cancer cells, other major players in the vicious interactive cycle of prostate cancer bone metastasis are osteoblasts, osteoclasts, and mineralized bone...
FDA Approves Neoadjuvant Pertuzumab for Early-Stage Breast Cancer
On September 30, 2013, the FDA granted accelerated approval to pertuzumab (Perjeta) in combination with trastuzumab (Herceptin) and docetaxel for patients with early-stage breast cancer in the neoadjuvant setting. Pertuzumab is the first FDA-approved drug for the neoadjuvant treatment of breast...
ASCO Survey: Drug Shortages Still a Problem Despite Slight Improvement
As part of its continued effort to monitor and assess the impact of oncology drug shortages, ASCO will be conducting the third round of its biannual survey of members. The results of the first two surveys indicated that serious problems persist in the accessibility of life-extending oncology drugs, ...
FDA Grants Breakthrough Therapy Status to Entinostat for Advanced Breast Cancer
Syndax Pharmaceuticals Inc announced that the U.S. Food and Drug Administration (FDA) has designated entinostat as a Breakthrough Therapy for the treatment of locally recurrent or metastatic estrogen receptor (ER)-positive breast cancer when added to exemestane in postmenopausal women whose disease ...
FDA Approves Nab-Paclitaxel for Late-Stage Pancreatic Cancer
The U.S. Food and Drug Administration (FDA) has expanded the approved uses of paclitaxel protein-bound particles for injectable suspension, albumin-bound (nab-paclitaxel, Abraxane) to treat patients with late-stage pancreatic cancer. “Patients with pancreatic cancer are often diagnosed after the...
FDA Approves First Generic Capecitabine to Treat Colorectal and Breast Cancers
The U.S. Food and Drug Administration (FDA) has approved the first generic version of capecitabine (Xeloda), an oral chemotherapy agent used in the treatment of metastatic colorectal cancer and breast cancers. Teva Pharmaceuticals USA has gained FDA approval to market generic capecitabine in 150...
