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Showing 3301 - 3350Ruxolitinib for Polycythemia Vera
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 December 4, 2014, ruxolitinib (Jakafi) was approved for the...
FDA Appoints Robert Califf, MD, Deputy Commissioner for Medical Products and Tobacco
U.S. Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg, MD, has appointed Robert Califf, MD, as the FDA Deputy Commissioner for Medical Products and Tobacco. Dr. Califf is a leader in cardiology, clinical research, and medical economics, who is currently serving as Vice...
FDA Expands Approved Use of Ibrutinib for Waldenström’s Macroglobulinemia
The U.S. Food and Drug Administration (FDA) today expanded the approved use of ibrutinib (Imbruvica) for patients with Waldenström’s macroglobulinemia, a rare, indolent type of B-cell lymphoma. Ibrutinib is the first therapy indicated specifically for Waldenström’s macroglobulinemia and previously...
News Roundup From the 2014 San Antonio Breast Cancer Symposium
Highlighted here are summaries of four abstracts presented at the 2014 San Antonio Breast Cancer Symposium: They focus on the EPO-ANE-3010 clinical trial of epoetin alfa (Epogen, Procrit) in anemic patients with metastatic breast cancer, a New York Cancer Consortium trial of fulvestrant (Faslodex)...
ASTRO Announces Additions to Management Team
The American Society for Radiation Oncology’s (ASTRO) Board of Directors has announced three additions to the Society’s management team: Emily Wilson has been named Executive Vice President; Dave Adler has been promoted to Vice President of Advocacy; and Anne Hubbard has been promoted to Director...
Capsaicin
Scientific name: 8-methyl-N-vanillyl-6-nonenamide Brand names: Zostrix cream 0.025% or 0.075%, Salonpas Gel-Patch Hot, Sinus Buster (homeopathic intranasal spray). The use of dietary supplements by patients with cancer has increased significantly over the past 20 years despite insufficient evidence ...
Blinatumomab in Philadelphia Chromosome–Negative Relapsed/Refractory B-Cell Precursor ALL
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 December 3, 2014, blinatumomab (Blincyto) was granted...
Ibrutinib for Waldenström’s Macroglobulinemia
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 January 29, 2015, the U.S. Food and Drug Administration (FDA)...
Pharmacokinetics and Exposure Response in Drug Development
INSIDE THE BLACK BOX is an occasional column offering insight into the U.S. Food and Drug Administration (FDA) and its policies and procedures. In this installment, former clinical pharmacology team leader Julie Bullock, PharmD, and current team leader Nitin Mehrotra, PhD, discuss how...
ASCO, AACR Call for Regulation of Electronic Nicotine Delivery Systems
ASCO and the American Association for Cancer Research (AACR) released a joint statement in January to guide policymakers as they work to minimize the potential negative consequences of electronic cigarettes (e-cigarettes) and other electronic nicotine delivery systems. Tobacco use, according to the ...
Conquer Cancer Foundation Researchers Lead Six Key Studies Featured in Clinical Cancer Advances 2015
Six of the studies featured in the recently released Clinical Cancer Advances 2015: ASCO’s Annual Report on Progress Against Cancer were led by researchers that whom Conquer Cancer Foundation (CCF) funded early in their careers through its signature Young Investigator Award (YIA) and Career...
ASCO Commends Margaret Hamburg, MD, for Leadership as FDA Commissioner
ASCO expresses deep gratitude to Margaret Hamburg, MD, for her 6 years of vision and progress as Commissioner of the U.S. Food and Drug Administration (FDA). Dr. Hamburg, one of the longest-serving FDA commissioners, leaves a legacy of important advances in regulatory science and medicine. The...
Douglas R. Lowy, MD, Receives Harrington Prize for Innovation in Medicine
The second annual Harrington Prize for Innovation in Medicine has been awarded to oncologist/researcher Douglas R. Lowy, MD, Chief of the Laboratory of Cellular Oncology and Deputy Director of the National Cancer Institute. The Harrington Prize for Innovation in Medicine, established in 2014 by...
Palbociclib as Initial Endocrine-Based Therapy in Postmenopausal Women With Metastatic 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. On February 3, 2015, palbociclib (Ibrance) was granted...
FDA Approves Lenalidomide in Combination With Dexamethasone for Newly Diagnosed Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has expanded the existing indication for lenalidomide (Revlimid) in combination with dexamethasone to include patients newly diagnosed with multiple myeloma. Lenalidomide plus dexamethasone was previously approved in June 2006 for use in multiple myeloma...
FDA Approves Panobinostat Combination for the Treatment of Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has approved panobinostat (Farydak) in combination with bortezomib (Velcade) and dexamethasone for the treatment of patients with multiple myeloma. Panobinostat is the first histone deacetylase (HDAC) inhibitor approved to treat multiple myeloma. It is...
For Hodgkin Lymphoma Patients, It Ain’t Over
With less than 10,000 patients diagnosed with Hodgkin lymphoma each year and a cure rate of approximately 75% to 80%, drug development for this disease was never a priority for pharmaceutical companies. So when the antibody-drug conjugate brentuximab vedotin (Adcetris) was approved by the U.S. Food ...
Crizotinib Crosses Another Finish Line in Lung Cancer
Treatment of anaplastic lymphoma kinase (ALK)–positive lung cancer has been one of the great success stories in oncology in the past decade. First discovered in lung cancer in 2007, ALK rearrangements are found in 3% to 5% of patients and define a distinct molecular subgroup of the disease with...
Human Reovirus Formulation Gets Orphan Drug Designation in Ovarian and Pancreatic Cancer
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation for Oncolytics Biotech’s proprietary formulation of the human reovirus (Reolysin) for the treatment of ovarian and pancreatic cancer. The reovirus’s primary mode of activity is to infect and selectively target tumors...
FDA Approves Lenvatinib for Progressive Radioiodine-Refractory Differentiated Thyroid Cancer
The U.S. Food and Drug Administration (FDA) has granted approval to lenvatinib (Lenvima) to treat patients with progressive, differentiated thyroid cancer whose disease progressed despite receiving radioactive iodine therapy. Lenvatinib is a tyrosine kinase inhibitor that binds to multiple sites...
FDA Grants Breakthrough Therapy Designation to MPDL3280A for Non–Small Cell Lung Cancer
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Genentech’s investigational cancer immunotherapy MPDL3280A for the treatment of PD-L1–positive non–small cell lung cancer (NSCLC) that has progressed during or after platinum-based chemotherapy (and an...
FDA Grants Cobimetinib Priority Review for Use in Combination With Vemurafenib in Advanced Melanoma
The U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for Genentech’s New Drug Application (NDA) for cobimetinib in combination with vemurafenib (Zelboraf) for the treatment of people with BRAF V600 mutation–positive advanced melanoma. The FDA will make a decision on...
FDA Approves Palbociclib in Combination With Letrozole for Advanced Breast Cancer
The U.S. Food and Drug Administration has granted accelerated approval to palbociclib (Ibrance) in combination with letrozole for the treatment of postmenopausal women with estrogen receptor–positive, HER2-negative metastatic breast cancer who have not yet received an endocrine-based therapy....
Expert Point of View: Hagan Kennecke, MD, Pamela L. Kunz, MD, and George Fisher, MD, PhD
Hagan Kennecke, MD, Associate Professor, University of British Columbia at the British Columbia Cancer Agency, said in an interview, “It was important to see the detailed subgroup analysis for pancreatic neuroendocrine tumors, because that is a major patient population we treat, and it was not...
Lanreotide Evaluated in Pancreatic Neuroendocrine Subgroup
The somatostatin analog lanreotide (Somatuline) depot extended the time to disease progression in patients with pancreatic neuroendocrine tumors, in a planned subgroup analysis of the CLARINET trial, Alexandria T. Phan, MD, of The Houston Methodist Hospital in Texas, reported at the 2015...
Study Finds Websites That Market Personalized Cancer Care Services Overemphasize Benefits
A recent analysis of 55 Internet websites marketing a broad range of tests and services that promise the ability to personalize cancer treatment has found that the websites often overemphasize their purported benefits and downplay their limitations. In addition, the study results show that the...
Herbal Supplements: Increasing Problems
In Don Quixote, the 1605 Spanish literary masterpiece by Miguel Cervantes, “Balsam of Fierabras” is mentioned often as a therapeutic panacea. It calls for mixing rosemary, wine, oil, and salt. As the story goes, the knight relied heavily on this herbal preparation to relieve him of pain from the...
Dinutuximab Combination Approved for Pediatric High-Risk Neuroblastoma
The U.S. Food and Drug Administration (FDA) has approved dinutuximab (Unituxin), a monoclonal antibody targeting glycolipid GD2, as part of first-line therapy for pediatric patients with high-risk neuroblastoma. A chimeric monoclonal antibody that binds to the surface of neuroblastoma cells,...
FDA Launches Drug Shortages Mobile App
Today, the U.S. Food and Drug Administration (FDA) launched the agency’s first mobile application (app) specifically designed to speed public access to valuable information about drug shortages. The app identifies current drug shortages, resolved shortages, and discontinuations of drug products....
FDA Takes Steps to Simplify Compassionate Use Process, Invites Comment
The U.S. Food and Drug Administration (FDA) introduced a more streamlined form for requesting permission for patient access to investigational drugs outside of clinical trials. The new form is available for comment in a draft guidance for industry entitled “Individual Patient Expanded Access...
ASCO Supports FDA’s Proposed Regulation of Laboratory Developed Tests
In comments submitted to the U.S. Food and Drug Administration (FDA), ASCO expressed its support for the agency’s draft guidance, “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs).” ASCO also strongly recommends that the agency proceed with regulatory authority in a way that...
FDA Names Geoffrey Kim, MD, Director of the Division of Oncology Products
The U.S. Food and Drug Administration (FDA) recently announced the appointment of Geoffrey Kim, MD, as Director of the Division of Oncology Products 1 (DOP1) in the Office of Hematology Oncology Products. Dr. Kim assumed this position effective March 22, 2015. Dr. Kim previously served as the...
Development and Approval of Biosimilar Products
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, Leah Christl, PhD, and Albert Deisseroth, MD, PhD, answer questions about biosimilar products. Dr. Christl is the Associate Director...
Many Cancer Patients at Risk for Hepatitis B Virus Reactivation
In 2015, no cancer patients should be cured of their malignancy only to die of reactivation of hepatitis B virus (HBV),” according to Anna S. Lok, MD, the Alice Lohrman Andrews Research Professor in Hepatology and Director of Clinical Hepatology at the University of Michigan, Ann Arbor. “I...
Priority Review Granted for Trabectedin in Advanced Soft-Tissue Sarcoma
The U.S. Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for trabectedin to treat patients with advanced soft-tissue sarcoma, including liposarcoma and leiomyosarcoma subtypes, who have received prior chemotherapy including an anthracycline. The NDA ...
Nivolumab in Metastatic Squamous Non–Small Cell Lung Cancer After Platinum Therapy
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 March 4, 2015, the anti–programmed cell death protein 1 (PD-1) ...
FDA Approves Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis and Invasive Mucormycosis
The U.S. Food and Drug Administration (FDA) has approved Astellas’ New Drug Application for the use of isavuconazonium sulfate (Cresemba), the prodrug for isavuconazole, for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis (also known as...
Biosimilar Filgrastim-sndz in Filgrastim Indications
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 March 6, 2015, the granulocyte colony-stimulating factor...
FDA Approves Nivolumab to Treat Metastatic Squamous NSCLC
The U.S. Food and Drug Administration (FDA) has approved the PD-1 inhibitor nivolumab (Opdivo) for the treatment of patients with metastatic squamous non–small cell lung cancer (NSCLC) who have progressed on or after platinum-based chemotherapy. Nivolumab is a monoclonal antibody that binds to the...
FDA Approves First Biosimilar Product Filgrastim-Sndz
The U.S. Food and Drug Administration (FDA) has approved filgrastim-sndz (Zarxio), the first biosimilar product approved in the United States. A biosimilar product is a biologic product that is approved based on a showing that it is highly similar to an already-approved biologic. The biosimilar...
Dinutuximab in Pediatric High-Risk Neuroblastoma
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 March 10, 2015, the chimeric monoclonal antibody dinutuximab...
The ASCO Post Replies
Nivolumab (Opdivo) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of lung cancer on March 4, 2015, before clinical data from the pivotal trials (CheckMate 017 and CheckMate 063) were presented at a major oncology conference or published in a peer-reviewed journal....
Widespread Use of Docetaxel Preceded Phase III Evidence of Usefulness in Patients With Metastatic Prostate Cancer
Docetaxel was being widely used by patients with metastatic prostate cancer before phase III evidence that it was more effective than the standard of care for patients with castration-resistant prostate cancer, according to an analysis of Medicare claims from before and after the trial results and...
Expect Questions About Cold Caps to Spare Hair During Chemotherapy
For patients who have confronted a diagnosis of cancer, then endured weeks of chemotherapy, it would seem that losing their hair would not be a big concern. But for many patients, it can be. “You have to spend a year either putting on wigs or announcing to the world that you’ve had chemotherapy,”...
Scalp Cooling Caps Offer Option to Prevent Hair Loss During Chemotherapy
Hair loss remains one of the most dreaded side effects of chemotherapy, particularly for women. Scalp cooling caps worn by patients during chemotherapy infusion and for brief periods of time before and after offer these patients an option to preserve 50% or more of the hair on their heads. Although ...
FDA Grants Priority Review to Carfilzomib Supplemental New Drug Application for Relapsed Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has accepted Amgen’s supplemental New Drug Application (sNDA) for carfilzomib (Kyprolis) injection for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. The sNDA is designed to support the conversion of ...
FDA Grants Breakthrough Therapy Designation to Rucaparib in Advanced Ovarian Cancer With BRCA Mutations
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Clovis Oncology’s investigational agent rucaparib as monotherapy treatment of advanced ovarian cancer in patients who have received at least two lines of prior platinum-containing therapy, with BRCA-mutated ...
FDA’s Biosimilar Product Approval Process: A Closer Look
In March, the U.S. Food and Drug Administration (FDA) approved filgrastim-sndz (Zarxio) as a biosimilar to U.S.-licensed filgrastim (Neupogen). It is the first biosimilar product to be approved in the United States and will increase treatment options for people living with cancer. The FDA considers ...
In Search of ‘Just’ Prices: Questioning the High Cost of New Cancer Drugs
As the oncology community begins the slow and often difficult-to-define transition from volume to value in the delivery of cancer care, the relationship between the price and value of certain high-priced cancer drugs is getting more scrutiny. We generally correlate the efficacy of a new drug and...
Breast Cancer Management in Review
With the field of breast oncology as complex as ever, a brief update of the latest findings impacting breast cancer treatment seems timely. To that end, I have assembled highlights from a collection of newsworthy studies featured over the past year and into early 2015. Part 1 of this review, which...
