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Showing 3651 - 3700Omacetaxine 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...
FDA Approves Ibrutinib for the Treatment of Chronic Lymphocytic Leukemia
The U.S. Food and Drug Administration (FDA) today expanded the approved use of ibrutinib (Imbruvica) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one previous therapy. Ibrutinib, an oral Bruton’s tyrosine kinase inhibitor, was previously...
Potential Therapeutic Role for Aspirin in the Management of Sporadic Vestibular Schwannoma
In patients with sporadic vestibular schwannoma, aspirin may be of benefit in minimizing tumor growth, according to the results of a retrospective study presented by Kandathil et al in Otology and Neurotology. This finding may eliminate the need for invasive therapy and may complement existing...
Dabrafenib Receives FDA Breakthrough Therapy Designation for BRAF-Mutated NSCLC
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for dabrafenib (Tafinlar) for the treatment of patients with metastatic BRAF V600E mutation–positive non–small cell lung cancer (NSCLC) who have received at least one prior line of...
FDA Accepts New Drug Application for Idelalisib in Refractory Indolent Non-Hodgkin Lymphoma
The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for idelalisib, a targeted, oral inhibitor of PI3K-delta, for the treatment of refractory indolent non-Hodgkin lymphoma (NHL). The FDA has granted a standard review for the NDA, with a target review date of...
FDA Approves Combination Therapy for Unresectable or Metastatic Melanoma With BRAF V600E/K Mutations
The U.S. Food and Drug Administration (FDA) has approved trametinib (Mekinist) for use in combination with dabrafenib (Tafinlar) for the treatment of patients with unresectable melanoma or metastatic melanoma with BRAF V600E or V600K mutations. These mutations must be detected by an FDA-approved...
Preclinical Study Suggests E-Cigarettes May Contribute to Lung Cancer in High-Risk Individuals
A study of human bronchial epithelial cells carrying mutations in the TP53 and KRAS genes has found that e-cigarette vapors enhanced the cells’ cancerous behaviors. The study suggests that e-cigarette exposure may contribute to lung cancer in individuals at high risk for the disease. The...
FDA Approves Revised Prescribing Information for Ponatinib, Authorizes Resumption of Drug Sales and Distribution
The U.S. Food and Drug Administration (FDA) has approved revised prescribing information and a Risk Evaluation and Mitigation Strategy (REMS) for ponatinib (Iclusig) that allows immediate resumption of its marketing and commercial distribution. The prescribing information includes a revised...
Novel BRAF Fusions Identified in 'Pan-Negative' Melanomas
A study by Sosman et al has identified two novel BRAF fusions in melanomas previously considered to be negative for molecular targets. In addition, these “pan-negative” melanomas were found to be sensitive to MEK inhibitors. According to the study, BRAF fusions define a new molecular...
Anastrozole Reduces Primary Breast Cancer Incidence by More Than 50% in High-Risk Postmenopausal Women
Five years of treatment with anastrozole reduced the risk of primary breast cancer by 53% in postmenopausal women at high risk for developing the disease, according to an analysis of the IBIS II trial. Anastrozole reduced the risk of estrogen receptor–positive invasive cancers by 58%. The...
NeoALTTO Trial Links Pathologic Complete Response to Clinical Outcomes
Final results of the phase III NeoALTTO trial have confirmed the value of pathologic complete response to dual HER2 blockade in the neoadjuvant setting. The achievement of pathologic complete response was associated with significantly improved event-free survival and overall survival in some women...
Vorinostat Plus Standard Immunoprophylaxis Cuts Risk of Graft-vs-Host Disease in Half
A new class of drugs reduced the risk of patients contracting a serious and often deadly side effect of bone marrow transplant treatments, according to a study by Choi et al published in The Lancet Oncology. The study, the first to test this treatment in humans, combined the drug vorinostat...
FDA Approves Sorafenib to Treat Late-Stage Differentiated Thyroid Cancer
The U.S. Food and Drug Administration today expanded the approved uses of sorafenib (Nexavar) to treat late-stage differentiated thyroid cancer. The new indication is for patients with locally recurrent or metastatic, progressive differentiated thyroid cancer that no longer responds to radioactive...
FDA Grants Regular Approval to Crizotinib for ALK-Positive NSCLC
The U.S. Food and Drug Administration (FDA) today granted regular approval for crizotinib (Xalkori) for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. Today’s...
FDA Approves Ibrutinib for Mantle Cell Lymphoma
The U.S. Food and Drug Administration today approved ibrutinib (Imbruvica) for the treatment of patients with mantle cell lymphoma, an aggressive B-cell lymphoma that represents about 6% of all non-Hodgkin lymphoma cases in the United States. The drug, a Bruton’s tyrosine kinase inhibitor, is ...
Phase II Trial of Ponatinib Shows Activity in Heavily Pretreated CML and Philadelphia Chromosome–Positive ALL
On October 31, 2013, Ariad Pharmaceuticals, the manufacturer of ponatinib, agreed to an FDA request to suspend marketing and sales of the drug due to the risk of life-threatening blood clots and severe narrowing of blood vessels. The FDA states that it will continue to evaluate ponatinib to further ...
Novel Agents Produce Encouraging Trends in Gastric Cancer
Several novel agents targeting the HER2, C-MET, and VEGF receptors have achieved encouraging results in gastric cancer, which is the second leading cause of cancer death worldwide. Charles Fuchs, MD, of Dana-Farber Cancer Institute, Boston, reviewed these new approaches in a presentation at the...
FDA Approves Transducer Array Layout System for Use in Patients With Recurrent Glioblastoma Multiforme
Novocure announced today that it has received U.S. Food and Drug Administration (FDA) approval for its NovoTAL (Transducer Array Layout) System through a Premarket Approval supplement. The NovoTAL System allows certified physicians to use the individual magnetic resonance imaging (MRI) data of...
FDA Approves Obinutuzumab for Chronic Lymphocytic Leukemia
The U.S. Food and Drug Administration (FDA) today approved obinutuzumab (Gazyva) for use in combination with chlorambucil (Leukeran) to treat patients with previously untreated chronic lymphocytic leukemia (CLL). Obinutuzumab is the first drug with Breakthrough Therapy designation to receive FDA...
Sale of Ponatinib Suspended Due to Risk of Life-Threatening Blood Clots
The U.S. Food and Drug Administration (FDA) has asked the manufacturer of the tyrosine kinase inhibitor ponatinib (Iclusig) to suspend marketing and sales of the drug because of the risk of life-threatening blood clots and severe narrowing of blood vessels. Ariad Pharmaceuticals has agreed to...
African American Women Are Less Likely to Benefit From HPV Vaccines for Cervical Cancer Prevention
Vaccines currently available to prevent the two most common strains of human papillomavirus (HPV), HPV 16 and 18, responsible for about 70% of cervical cancers, may not be protective in African American women, according to a study by Cathrine Hoyo, PhD, MPH, Associate Professor in the Obstetrics...
FDA Approves First Extended-Release, Single-Entity Hydrocodone Product
The U.S. Food and Drug Administration (FDA) today approved hydrocodone bitartrate extended-release capsules (Zohydro ER) for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate. The drug, a Schedule ...
New Molecular Diagnostics Platform Enables Rapid Detection of BRAF V600 Mutations
A new diagnostic platform to detect BRAF mutations in melanoma and other cancer types is faster and more accurate compared with the standard method currently used in clinics, and this could help accelerate diagnosis and treatment, according to results presented at the AACR-NCI-EORTC International...
FDA Grants Priority Review to Ramucirumab as a Potential Single-Agent Treatment for Advanced Gastric Cancer
The U.S. Food and Drug Administration (FDA) has assigned Priority Review to the regulatory submission for ramucirumab (IMC-1121B) as a single-agent treatment for advanced gastric cancer following disease progression after initial chemotherapy. Ramucirumab is a human monoclonal antibody that...
FDA Investigating Ponatinib After Increased Reports of Serious Blood Clots in Arteries and Veins
The U.S. Food and Drug Administration (FDA) is investigating an increasing frequency of reports of serious and life-threatening blood clots and severe narrowing of blood vessels of patients taking the antileukemia drug ponatinib (Iclusig). Ponatinib is indicated for the treatment of patients with...
Program 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...
