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Showing 3601 - 3650FDA Grants Priority Review to Lanreotide Injection for Gastroenteropancreatic Neuroendocrine Tumors
The U.S. Food and Drug Administration (FDA) has accepted and granted priority review to Ipsen’s supplemental New Drug Application (sNDA) for the somatostatin analog lanreotide (Somatuline Depot) 120 mg injection in the treatment of gastroenteropancreatic neuroendocrine tumors. The FDA...
Oncologists Respond Rapidly to Clinical Trial Evidence on Use of EGFR Inhibitors
Use of panitumumab (Vectibix) and cetuximab (Erbitux) in patients with metastatic colorectal cancer decreased significantly after the publication of clinical trial evidence that anti-EGFR antibodies should be restricted to wild-type KRAS tumors, subsequent ASCO guidelines recommending testing for...
FDA Approves Bevacizumab for Aggressive and Late-Stage Cervical Cancer
The U.S. Food and Drug Administration (FDA) has approved the antiangiogenic agent bevacizumab (Avastin) for the treatment of persistent, recurrent, or metastatic cervical cancer. The new indication is approved for use in combination with paclitaxel and cisplatin or paclitaxel and topotecan. The FDA ...
FDA Approves First Noninvasive DNA Screening Test for Colorectal Cancer
The U.S. Food and Drug Administration (FDA) today approved Cologuard, the first stool-based colorectal screening test that detects the presence of red blood cells and DNA mutations that may indicate the presence of certain kinds of abnormal growths that may be cancers such as colon cancer or...
FDA Approves Bortezomib Retreatment in Patients With Multiple Myeloma
The U.S. Food and Drug Administration has approved bortezomib (Velcade) for the retreatment of adult patients with multiple myeloma who had previously responded to bortezomib therapy and relapsed at least 6 months following completion of prior bortezomib treatment. The labeling update includes...
FDA Grants Orphan Drug Designation to Mocetinostat for Diffuse Large B-Cell Lymphoma
The U.S. Food and Drug Administration has granted Orphan Drug Designation to Mirati Therapeutics’ mocetinostat, a spectrum-selective HDAC inhibitor, for diffuse large B-cell lymphoma. In June, mocetinostat was granted Orphan Drug Designation as a treatment for myelodysplastic syndrome....
FDA Grants Fast Track Designation to Novel JAK2 Inhibitor for the Treatment of Myelofibrosis
The U.S. Food and Drug Administration has granted Fast Track designation to pacritinib for the treatment of intermediate- and high-risk myelofibrosis, including patients with disease-related thrombocytopenia on other JAK2 therapy or patients who are intolerant to or whose symptoms are suboptimally...
Ruxolitinib Granted Priority Review for Polycythemia Vera
The U.S. Food and Drug Administration (FDA) has accepted for filing and granted Priority Review to the supplemental New Drug Application (sNDA) for ruxolitinib (Jakafi) as a potential treatment of patients with polycythemia vera who have had an inadequate response to or are intolerant of...
Investigational Compound ABT-414 Receives Orphan Drug Designation for Glioblastoma Multiforme
The U.S. Food and Drug Administration has granted orphan drug designation to AbbVie’s investigational compound ABT-414, which is being evaluated for safety and efficacy in patients with glioblastoma multiforme. ABT-414 is an investigational anti-EGFR (epidermal growth factor receptor)...
FDA Expands Approved Use of Ibrutinib for Chronic Lymphocytic Leukemia
The U.S. Food and Drug Administration (FDA) today expanded the approved use of ibrutinib (Imbruvica) to treat patients with chronic lymphocytic leukemia (CLL) who carry deletions of the short arm of chromosome 17, which are associated with poor responses to standard treatment for CLL. Ibrutinib...
FDA Approves Idelalisib for Three Types of Blood Cancers
The U.S. Food and Drug Administration (FDA) has approved idelalisib (Zydelig) for the treatment of patients with three types of blood cancers. Idelalisib is being granted traditional approval to treat patients with relapsed chronic lymphocytic leukemia (CLL). Used in combination with rituximab...
FDA Grants Bevacizumab Priority Review for Recurrent Platinum-Resistant Ovarian Cancer
The U.S. Food and Drug Administration (FDA) has accepted Genentech’s supplemental Biologics License Application and granted Priority Review for bevacizumab (Avastin) plus chemotherapy for the treatment of women with recurrent platinum-resistant ovarian cancer. “The majority of women...
FDA Grants Bevacizumab Priority Review for Certain Types of Cervical Cancer
The U.S. Food and Drug Administration (FDA) has accepted Genentech’s supplemental Biologics License Application and granted Priority Review for bevacizumab (Avastin) plus chemotherapy in the treatment of women with persistent, recurrent, or metastatic cervical cancer. The designation...
FDA Grants Breakthrough Therapy Designation to Investigational Chimeric Antigen Receptor Therapy for Relapsed/Refractory ALL
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy status to CTL019, an investigational chimeric antigen receptor (CAR) therapy for the treatment of pediatric and adult patients with relapsed/refractory acute lymphoblastic leukemia (ALL). The Breakthrough Therapy filing...
FDA Grants Orphan Drug Designation to ENMD-2076 for Hepatocellular Carcinoma
CASI Pharmaceuticals, Inc, announced that its investigational agent ENMD-2076 has received orphan drug designation from the U.S. Food & Drug Administration (FDA) for the treatment of hepatocellular carcinoma. ENMD-2076 is an orally active Aurora A/angiogenic kinase inhibitor with a unique...
FDA Approves Belinostat for Relapsed or Refractory Peripheral T-Cell Lymphoma
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to belinostat (Beleodaq), a histone deacetylase inhibitor, for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma, a rare and fast-growing type of non-Hodgkin lymphoma (NHL). “This is...
FDA Grants Breakthrough Therapy Designation to Blinatumomab for Acute Lymphoblastic Leukemia
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to blinatumomab for adults with Philadelphia chromosome–negative relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL), a rapidly progressing cancer of the blood and bone marrow....
FDA Advisory Committee Votes Against Accelerated Approval for Olaparib in Ovarian Cancer
The U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 11 to 2 that current evidence from clinical studies does not support an accelerated approval for use of olaparib as a maintenance treatment for women with platinum-sensitive relapsed ovarian cancer who have...
BPA Stimulates Growth of Breast Cancer Cells, Diminishes Effect of Treatment
Bisphenol A (BPA), a chemical commonly used in plastics, appears to increase the proliferation of breast cancer cells, according to Duke Medicine researchers presenting at ICE/ENDO 2014, the annual joint meeting of the International Society of Endocrinology and the Endocrine Society in Chicago. The ...
FDA Approves Radioactive Diagnostic Imaging Agent to Help Determine the Extent of Head and Neck Cancer in the Body
The U.S. Food and Drug Administration today approved a new use for technetium 99m tilmanocept (Lymphoseek Injection), a radioactive diagnostic imaging agent used to help doctors determine the extent to which squamous cell carcinoma has spread in the body’s head and neck region. In 2013,...
FDA Approves Magnetic Resonance Contrast Agent for Evaluation of Breast Cancer
The U.S. Food and Drug Administration has approved a new indication for gadobutrol (Gadavist) injection for intravenous use with magnetic resonance imaging (MRI) of the breast to assess the presence and extent of malignant breast disease. The approval is based on priority review of two multicenter...
ASCO 2014: PD-1–Targeting Antibody Pembrolizumab Produces Long-Term Responses in Patients With Metastatic Melanoma
Findings from a large phase I study of 411 patients with advanced melanoma show that the PD-1–targeting antibody pembrolizumab (MK-3475) produced responses in 34% of patients, including 28% of patients whose disease progressed on prior treatment with ipilimumab (Yervoy). Among those who...
ASCO 2014: Adjuvant Ipilimumab Significantly Improves Recurrence-Free Survival in Patients With High-Risk Stage III Melanoma
Adjuvant therapy with ipilimumab (Yervoy) for patients with high-risk stage III melanoma significantly improved recurrence-free survival, the primary endpoint of the phase III EORTC 18071/CA 184-029 study. Patients randomly assigned to receive ipilimumab had a 9-month absolute improvement in...
ASCO 2014: Ceritinib Shows Rapid, Durable Response in ALK-Positive NSCLC
In a phase I study, ceritinib (Zykadia) was found to shrink tumors in patients with anaplastic lymphoma kinase (ALK)-positive non–small cell lung cancer (NSCLC), regardless of whether patients had received previous treatment with an ALK inhibitor. The study was presented at the 2014 ASCO...
ASCO 2014: Adding Lapatinib to Adjuvant Trastuzumab Does Not Improve Outcomes in Early-Stage HER2-Positive Breast Cancer
A large phase III study, ALTTO (Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation), found no statistically significant differences in 4-year disease-free survival among women with early HER2-positive breast cancer who received adjuvant treatment that combined the HER2-targeted drugs...
ASCO 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...
