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Showing 3601 - 3650ASCO 2014: Investigational Anti–PD-L1 Antibody Demonstrates Promising Activity in Certain Patients With Metastatic Bladder Cancer
In a phase I study, the investigational anti–programmed death-ligand 1 (PD-L1) monoclonal antibody MPDL3280A demonstrated promising overall response rates in patients with previously treated metastatic urothelial bladder cancer whose tumors were characterized as PD-L1–positive. The ...
FDA Approves Palonosetron Hydrochloride to Prevent 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...
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...
Study Confirms Clinical Benefit for Interleukin-2 Immunotherapy in Patients With Advanced Kidney Cancer
A retrospective study published online ahead of print in Urology by researchers at Roswell Park Cancer Institute found that patients with metastatic kidney cancer—even those with chronic renal insufficiency—can tolerate and benefit from high-dose interleukin-2 (HDIL-2) immunotherapy....
FDA Approves Omacetaxine Mepesuccinate for Injection for Home Administration
The U.S. Food and Drug Administration (FDA) has approved omacetaxine mepesuccinate (Synribo) for injection, for subcutaneous use, to include home administration, and also approved a related Medication Guide and Instructions for Use. With this approval, physicians who treat adults with chronic- or...
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...
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 Approves First HPV Test for Primary Cervical Cancer Screening
The U.S. Food and Drug Administration (FDA) today 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...
FDA Proposes to Extend Its Tobacco Authority to Additional Tobacco Products, Including E-Cigarettes
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) today proposed a new rule that would extend the agency’s tobacco authority to cover additional tobacco products. ...
FDA Approves Siltuximab for Rare Castleman’s Disease
The U.S. Food and Drug Administration (FDA) today 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...
FDA Grants Orphan Drug Designation to Alvocidib for the Treatment of Acute Myeloid Leukemia
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to alvocidib, a potent cyclin-dependent kinase small-molecule inhibitor, for the treatment of patients with acute myeloid leukemia (AML). The agent is being tested in patients with intermediate- or high-risk AML, who...
Experimental Drug Receives Fast Track Designation as Second-Line Chemotherapy for Metastatic Castration-Resistant Prostate Cancer
OncoGenex Pharmaceuticals, Inc, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the investigation of custirsen (OGX-011) when administered in combination with cabazitaxel (Jevtana Kit)/prednisone for the treatment of men with metastatic...
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....
FDA Discourages Use of Laparoscopic Power Morcellation for Removal of Uterus or Uterine Fibroids
In a safety communication notice issued yesterday, the U.S. Food and Drug Administration (FDA) discouraged the use of laparoscopic power morcellation for the removal of the uterus (hysterectomy) or uterine fibroids (myomectomy) in women because, based on an analysis of currently available data, it...
FDA Approves Ofatumumab for Previously Untreated Chronic Lymphocytic Leukemia
The U.S. Food and Drug Administration (FDA) today approved ofatumumab (Arzerra) injection in combination with chlorambucil (Leukeran) for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL), for whom fludarabine-based therapy is considered inappropriate. Trial...
Volasertib Granted Orphan Drug Designation for Acute Myeloid Leukemia
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to volasertib for acute myeloid leukemia (AML). Volasertib is currently being evaluated in a phase III clinical trial for the treatment of patients aged 65 or older, with previously untreated AML, who are ineligible for ...
FDA Approves Ethiodized Oil Injection for Imaging of Tumors in Adults With Known Hepatocellular Carcinoma
The U.S. Food and Drug Administration has approved ethiodized oil injection (Lipiodol) for selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma. The agent received orphan drug designation for management of patients with known hepatocellular carcinoma ...
Palbociclib Plus Letrozole Achieves Impressive Results in Metastatic Breast Cancer
First-line treatment with the combination of palbociclib plus letrozole extended progression-free survival by approximately 50% in patients with metastatic estrogen receptor–positive, HER2-negative breast cancer, according to final results of a randomized phase II study presented at the...
FDA Panel Endorses Stool-Based DNA Colon Cancer Test
The U.S. Food and Drug Administration’s (FDA) committee of genetic experts has determined that Cologuard, a stool-based DNA, noninvasive screening test for colorectal cancer, has demonstrated safety, effectiveness, and a favorable risk-benefit profile. The FDA is now considering the...
Electronic Cigarette Usage Associated With Use of Conventional Cigarettes Among Adolescents
“Use of e-cigarettes does not discourage, and may encourage, conventional cigarette use among US adolescents.” This was the conclusion of a cross-sectional analysis of survey data from a representative sample of middle and high school students who completed the National Youth Tobacco...
FDA Advisory Committee Unanimously Recommends HPV Test as Primary Screening Tool for Detection of Women at High Risk for Cervical Cancer
The U.S. Food and Drug Administration (FDA) Microbiology Devices Panel of the Medical Devices Advisory Committee has recommended unanimously that the benefits of the cobas human papillomavirus (HPV) test outweigh the risks as a first-line primary screening tool to assess the risk of cervical cancer ...
Common Cancers Evade Detection by Silencing Parts of Immune System Cells, Study Finds
Immunotherapy for ovarian, breast, and colorectal cancer has so far had limited success, primarily because the immune system often can’t destroy the cancer cells. According to a report published in Oncotarget, researchers at Johns Hopkins have identified genes that have been repressed through ...
Pathologic Complete Response Has Prognostic Value in Breast Cancer, But Is Not Supported as Surrogate for Event-Free or Overall Survival
Pathologic complete response has been proposed as a surrogate endpoint for long-term clinical benefit in breast cancer. The U.S. Food and Drug Administration (FDA) established the international Collaborative Trials in Neoadjuvant Breast Cancer working group to perform a pooled analysis of...
Leukemia & Lymphoma Society Applauds FDA's Approval of Ibrutinib for CLL
In response to FDA's approval earlier this week of ibrutinib (Imbruvica) to treat patients with chronic lymphocytic leukemia (CLL) who had received at least one prior therapy, The Leukemia & Lymphoma Society (LLS) issued the following statement: "After the FDA designated ibrutinib as a...
Compound Screening Identifies Novel Treatment Options for Gastrointestinal Stromal Tumors
Using high-throughput screening of already FDA-approved chemotherapeutic agents in gastrointestinal stromal tumors (GIST) cell lines, researchers have discovered that GIST cells display a high sensitivity to transcriptional and topoisomerase II inhibitors. The finding could bring new treatments to...
Omacetaxine 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...
