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Showing 3651 - 3700Program Chairs Highlight Abstracts of Interest for the 2013 CTRC-AACR San Antonio Breast Cancer Symposium
The Program Chairs of the 2013 CTRC-AACR San Antonio Breast Cancer Symposium, which will be held December 10–14, 2013, have highlighted what they consider to be the most important abstracts to be presented at the Symposium. In a telebriefing in advance of the December meeting, C. Kent...
ECC 2013: Strong Showing for Ado-Trastuzumab Emtansine in Heavily Pretreated Advanced HER2-Positive Breast Cancer
Results of the phase III TH3RESA trial show that the antibody-conjugate ado-trastuzumab (Kadcyla, previously known as T-DM1) extends progression-free survival in women with advanced HER2-positive breast cancer that progressed on two or more previous HER2-directed therapies including trastuzumab...
FDA Approves Neoadjuvant Pertuzumab for Early-Stage Breast Cancer
The U.S. Food and Drug Administration (FDA) today 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...
Repurposed Antidepressants May Have Potential to Treat Small Cell Lung Cancer
A bioinformatics approach to repurposing drugs resulted in identification of a class of antidepressants as a potential new treatment for small cell lung cancer, according to a study published in Cancer Discovery. Based on data generated using bioinformatics, two drugs approved by the U.S. Food and ...
USPSTF Issues Final Recommendation Statement on Medications for the Risk Reduction of Primary Breast Cancer in Women
The U.S. Preventive Services Task Force (USPSTF) released today its final recommendation statement on medications to reduce the risk of primary breast cancer in women. Clinicians are recommended to prescribe risk-reducing medications, such as tamoxifen or raloxifene, for women who are at increased...
NCCN: Practical Considerations in Selecting Tyrosine Kinase Inhibitor Therapy for Chronic Myeloid Leukemia
Although imatinib (Gleevec) is the initial therapy for chronic myeloid leukemia (CML), several second-generation tyrosine kinase inhibitors are now approved for the treatment of this disease. Michael Millenson, MD, of Fox Chase Cancer Center in Philadelphia, reviewed practical considerations in...
Pomalidomide Produces ‘Impressive Results’ in Patients With Multiple Myeloma 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 and bortezomib,” according to a review of clinical data leading to the drug’s approval by the U.S. Food and Drug...
New Medical Device Treats Urinary Symptoms Related to Benign Prostatic Hyperplasia
The U.S. Food and Drug Administration has authorized the marketing of the UroLift system, a permanent implant to relieve low or blocked urine flow in men age 50 and older with benign prostatic hyperplasia. As men age, the prostate can become enlarged, also known as benign prostatic hyperplasia....
FDA Grants Priority Review Designation for Dabrafenib/Trametinib Combination in Metastatic Melanoma
GlaxoSmithKline recently announced that the U.S. Food and Drug Administration has granted Priority Review designation to its supplemental New Drug Applications for the combined use of dabrafenib (Tafinlar) and trametinib (Mekinist) for the treatment of adult patients with unresectable or metastatic ...
FDA Grants Volasertib Breakthrough Therapy Designation in Acute Myeloid Leukemia
Boehringer Ingelheim Pharmaceuticals, Inc, has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to volasertib, an investigational inhibitor of polo-like kinase (Plk), which being evaluated for the treatment of patients aged 65 or older with...
AACR Issues 2013 Cancer Progress Report
The American Association for Cancer Research (AACR) released its Cancer Progress Report 2013 today. And while there is much to celebrate in the significant progress made in cancer research—which has led to more effective therapies for the more than 200 types of cancer and increased...
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...
FDA Grants Ofatumumab Breakthrough Therapy Designation for Previously Untreated CLL
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for ofatumumab (Arzerra) in combination with chlorambucil (Leukeran) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have not received prior treatment and are inappropriate for...
ODAC Recommends Accelerated Approval of Pertuzumab for HER2-Positive, Early-Stage Breast Cancer
The U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 13 to 0, with one abstention, in favor of recommending accelerated approval of a pertuzumab (Perjeta) regimen for neoadjuvant treatment in patients with high-risk, HER2-positive, early-stage breast...
FDA Grants Breakthrough Therapy Status to Entinostat for Advanced Breast Cancer
Syndax Pharmaceuticals Inc today 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...
FDA Announces Class-Wide Safety Labeling Changes for Long-Acting Opioid Analgesics to Combat Abuse
The U.S. Food and Drug Administration (FDA) today announced class-wide safety labeling changes and new postmarketing study requirements for all extended-release and long-acting opioid analgesics intended to treat pain. “The FDA is invoking its authority to require safety labeling changes and ...
Cabozantinib Improves Disease-Free Survival in Progressive Medullary Thyroid Cancer
Cabozantinib (Cometriq) is an inhibitor of hepatocyte growth factor receptor (MET), VEGFR2, and rearranged during transfection (RET) tyrosine kinases. In a phase III trial reported in Journal of Clinical Oncology, Rosella Elisei, MD, of the University of Pisa, and colleagues found that cabozantinib ...
FDA Approves Nab-Paclitaxel for Late-Stage Pancreatic Cancer
The U.S. Food and Drug Administration (FDA) today 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...
Sorafenib Granted Priority Review for Differentiated Thyroid Cancer
Bayer HealthCare and Onyx Pharmaceuticals 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. The...
FDA Approves Mechlorethamine Gel for Cutaneous T-Cell Lymphoma
Ceptaris Therapeutics, Inc, announced today 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...
Enhanced Treatment, Surveillance Needed for Certain Melanoma Patients to Prevent Secondary Cancers, Researchers Say
Researchers at Moffitt Cancer Center in Tampa, Florida, 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...
Brain Cancer Survival Improved Following FDA Approval of Bevacizumab, Mayo Study Finds
A new population-based study has found that patients with glioblastoma who died in 2010, after the FDA approval of bevacizumab (Avastin), had lived significantly longer than patients who died of the disease in 2008, prior to the conditional approval of the drug for the treatment of brain...
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....
Best of ASCO 2013: Off-Label Prescribing of Chemotherapy Drugs Is Common but Most 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 Cancer Network (NCCN) Drugs & Biologics Compendium, according to a study reviewed at Best of ASCO Chicago by Monika K. Krzyzanowska, MD, MPH, of ...
FDA Approves Dolutegravir to Treat HIV-1 Infection
The U.S. Food and Drug Administration (FDA) today approved dolutegravir (Tivicay), a new drug to treat HIV-1 infection. Dolutegravir is an oral integrase strand transfer inhibitor that interferes with one of the enzymes necessary for HIV to multiply. The drug is taken in combination with other...
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) today 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...
FDA Grants Orphan Drug Status to Eisai’s Investigational Compound E7777 for Cutaneous T-Cell Lymphoma
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Eisai’s investigational compound E7777 for cutaneous T-cell lymphoma. E7777 is designed to have an improved purity profile and manufacturing process. It is currently in a pivotal trial intended to support ...
Study Reveals Genes That Drive Glioblastoma
A team of researchers at the Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center has identified 18 new genes responsible for driving glioblastoma multiforme, the most common—and most aggressive—form of brain cancer in adults. The study was published online...
FDA Warns of Rare but Serious Skin Reactions with Acetaminophen
The U.S. Food and Drug Administration (FDA) is informing the public 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...
FDA Limits Usage of Oral Ketoconazole Due to Potentially Fatal Liver Damage
The U.S. Food and Drug Administration (FDA) announced today that oral ketoconazole should not be used as first-line treatment for any fungal infection and should only be used for the treatment of endemic mycoses when alternative antifungal therapies are not available or tolerated. The use of...
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...
FDA Approves Afatinib for EGFR-mutant Late-stage Non–Small Cell Lung Cancer
The U.S. Food and Drug Administration (FDA) today 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...
New Drug Application Submitted for Ibrutinib in the Treatment of Two B-cell Malignancies
Pharmacyclics, Inc, today 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) and...
FDA Grants Priority Review to Obinutuzumab in CLL and Pertuzumab in Neoadjuvant Therapy for HER2-positive Early-stage Breast Cancer
Two drugs were given Priority Review designation by FDA earlier this week. Obinutuzumab (GA101) was granted Priority Review for the treatment of chronic lymphocytic leukemia (CLL), based on final stage 1 data from the pivotal CLL11 trial. FDA also granted Priority Review to a pertuzumab (Perjeta)...
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...
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 ...
FDA Approves Denosumab to Treat Giant Cell Tumor of the Bone
The U.S. Food and Drug Administration (FDA) today 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 ...
ASCO 2013: Lung Cancer Mutations ALK and ROS1 Also Drive Colorectal Cancer
A study from the University of Colorado Cancer Center shows that the ALK and ROS1 gene rearrangements known to drive subsets of lung cancer are also present in some colorectal cancers. Results imply that drugs used to target ALK and ROS1 in lung cancer may also have applications in this subset of...
FDA Grants Orphan Drug Status for Novel Targeted Therapy for the Treatment of 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...
FDA Clears Multicenter Trial of Treatment for Chemotherapy-related Hair Loss
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...
ASCO 2013: Adapting to Ongoing Shortages of Common Cancer Drugs
A survey of 214 U.S. oncologists and hematologists found that more than 80% encountered cancer drug shortages between March and September of 2012, and many reported that shortages affected the quality of patient care they were able to provide. As physicians were forced to substitute more expensive...
FDA Approves Lenalidomide for Patients with Relapsed or Refractory Mantle Cell Lymphoma
The U.S. Food and Drug Administration today 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 ...
ASCO 2013: Sorafenib Stalls Growth of Treatment-resistant Differentiated Thyroid Cancer
A randomized phase III study found that the targeted drug sorafenib (Nexavar) stalls disease progression by 5 months in patients with metastatic differentiated thyroid cancer that has progressed despite standard radioactive iodine therapy. If approved in this setting by the U.S. Food and Drug...
ASCO 2013: Adding Bevacizumab to Standard First-line Chemoradiation for Glioblastoma Does Not Improve Overall Survival
A randomized phase III study found no improvement in overall survival after the addition of bevacizumab (Avastin) to standard first-line chemoradiation for glioblastoma. Patients who received bevacizumab also experienced more side effects compared to those treated with chemoradiation alone. The...
ASCO 2013: Adding Bevacizumab to Chemotherapy Significantly Improves Response Rates and Survival in Women with Advanced Cervical Cancer
Adding bevacizumab (Avastin) to chemotherapy regimens with or without a platinum drug improved outcomes for women with metastatic or relapsed cervical cancer treated in a randomized phase III study. Presenting the results at the 2013 ASCO Annual Meeting (Abstract 3), lead author Krishnansu Sujata...
In the Clinic: 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...
FDA Grants Fast Track Designation to SGX942 for the 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...
ASCO 2013: Pazopanib Maintenance Therapy Delays Relapse of Advanced Ovarian Cancer
A phase III clinical trial has found that pazopanib (Votrient), an oral multikinase inhibitor, extends disease-free survival by an average of 5.6 months, compared to placebo, in women with advanced ovarian cancer who had initial successful treatment with surgery and chemotherapy. “Our...
FDA Approves Two Drugs, Companion Diagnostic Test for Advanced Skin Cancer
The U.S. Food and Drug Administration today approved two new drugs, dabrafenib (Tafinlar) and trametinib (Mekinist), for patients with advanced or unresectable melanoma, the most dangerous type of skin cancer. Dabrafenib, a BRAF inhibitor, is approved to treat patients with melanoma whose tumors...
FDA Approves Low-dose, Two-dimensional Mammography Software
Hologic, Inc, announced today that the U.S. Food and Drug Administration (FDA) has approved the use of C-View, a new low-dose two-dimensional (2D) imaging software. C-View 2D images may now be used in place of the conventional 2D exposure previously required as part of Hologic’s FDA-approved...
