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Showing 3551 - 3600FDA Grants Orphan Drug Designation to BGB324 for Acute Myeloid Leukemia
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to BGB324 for the treatment of acute myeloid leukemia (AML). BGB324 is a first-in-class, highly selective small-molecule inhibitor of the Axl receptor tyrosine kinase. It blocks the epithelial-mesenchymal transition...
FDA Approves Bevacizumab Plus Chemotherapy for Platinum-Resistant, Recurrent Ovarian Cancer
The U.S. Food and Drug Administration (FDA) approved bevacizumab (Avastin) in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for the treatment of patients with platinum-resistant, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. AURELIA Trial ...
FDA Approves Ramucirumab in Combination With Paclitaxel for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
The U.S. Food and Drug Administration (FDA) today approved ramucirumab (Cyramza) for use in combination with paclitaxel for the treatment of patients with advanced gastric or gastroesophageal junction adenocarcinoma. Ramucirumab was approved in April 2014 as a single agent for the treatment of...
Oncology Advances Included in Cleveland Clinic's Top 10 Medical Innovations List for 2015
Antibody-drug conjugates, checkpoint inhibitors, and single-dose intraoperative radiation therapy for breast cancer were included in the Cleveland Clinic's Ninth Annual Top 10 Medical Innovations List released earlier today. The list identifies those advances likely to have a major impact on...
FDA Grants Breakthrough Therapy Designation Pembrolizumab in Advanced Non–Small Cell Lung Cancer
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to the anti–PD-1 therapy pembrolizumab (Keytruda) for the treatment of patients with epidermal growth factor receptor (EGFR) mutation–negative, and anaplastic lymphoma kinase (ALK)...
TAS-102 Receives FDA Fast Track Designation for Refractory Metastatic Colorectal Cancer
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Taiho Oncology’s TAS-102, a novel agent currently under investigation for the treatment of refractory metastatic colorectal cancer. TAS-102 is an oral combination investigational anticancer drug consisting of...
FDA Grants Lenvatinib Priority Review Designation for Advanced Thyroid Cancer
The U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application for lenvatinib mesylate as a treatment for progressive radioactive iodine–refractory differentiated thyroid cancer and granted the application Priority Review status. Lenvatinib is an oral multiple...
FDA Approves Expanded Use of Tilmanocept for Lymphatic Mapping in Solid Tumors
The U.S. Food and Drug Administration (FDA) has approved the Supplemental New Drug Application for the expanded use of technetium 99m tilmanocept (Lymphoseek Injection) for lymphatic mapping in solid tumors and for adding sentinel lymph node detection for breast cancer and melanoma to the approved...
FDA Grants Priority Review to Palbociclib as First-Line Therapy in Combination With Letrozole in Advanced Breast Cancer
The U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to Pfizer’s New Drug Application for palbociclib, in combination with letrozole, as a first-line treatment for postmenopausal women with estrogen receptor–positive, HER2-negative advanced breast cancer...
Blinatumomab Receives FDA Priority Review Designation in Acute Lymphoblastic Leukemia
The U.S. Food and Drug Administration (FDA) has accepted for review Amgen’s Biologics License Application for blinatumomab for the treatment of adults with Philadelphia chromosome–negative relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL). As part of the acceptance, the ...
FDA Approves Bortezomib Injection for Previously Untreated Patients With Mantle Cell Lymphoma
The U.S. Food and Drug Administration (FDA) has approved bortezomib (Velcade) injection for previously untreated patients with mantle cell lymphoma. This is the first treatment in the United States to be approved for use in previously untreated patients with mantle cell lymphoma. Bortezomib was...
FDA Approves Netupitant and Palonosetron Combination Capsule for Chemotherapy-Induced Nausea and Vomiting
The U.S. Food and Drug Administration (FDA) today approved a combination of netupitant and palonosetron (Akynzeo) to treat nausea and vomiting in patients undergoing cancer chemotherapy. The new drug, also known as NEPA, is a fixed-combination capsule comprised of two agents: oral palonosetron,...
FDA Grants Orphan Drug Designation to DNX-2401 for Malignant Glioma
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to DNAtrix’s DNX-2401, a conditionally-replicative oncolytic adenovirus for malignant glioma. Glioma is the most common form of primary brain cancer, the treatment of which remains a significant unmet medical...
FDA Grants Orphan Drug Designation to Investigational Agent for Pancreatic Cancer
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to pegylated recombinant human hyaluronidase (PEGPH20) for the treatment of pancreatic cancer. Halozyme Therapeutics is currently investigating PEGPH20 in a phase II study in combination with gemcitabine and...
FDA Grants Breakthrough Therapy Designation to AP26113 for ALK-Positive NSCLC
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Ariad Pharmaceutical’s investigational agent AP26113 for patients with anaplastic lymphoma kinase (ALK)-positive metastatic non–small cell lung cancer (NSCLC) who are resistant to crizotinib...
Next-Generation HPV Vaccine May Prevent 90% of Cervical Cancer Cases Worldwide
A study of a nine-valent human papillomavirus (HPV) vaccine that provides protection against HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, has found it to be highly safe and efficacious. If vaccination programs with this new-generation vaccine are effectively implemented, approximately 90% of...
ESMO 2014: Adding Cediranib to Chemotherapy Improves Progression-Free Survival in Metastatic or Recurrent Cervical Cancer
For patients with recurrent or metastatic cervical cancer, adding the experimental drug cediranib to standard chemotherapy improved tumor shrinkage and resulted in a modest improvement in progression-free survival, researchers reported at the ESMO 2014 Congress in Madrid (Abstract LBA25_PR). In...
Aldoxorubicin Receives FDA Orphan Drug Designations for Glioblastoma, Small Cell Lung Cancer, and Ovarian Cancer
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designations to aldoxorubicin in three indications: glioblastoma multiforme, small cell lung cancer, and ovarian cancer. Aldoxorubicin combines doxorubicin with a novel single-molecule linker that binds directly and...
FDA Grants Orphan Drug Designation to Bivalent Vaccine for Neuroblastoma
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to MabVax Therapeutics’ vaccine for the treatment of relapsed or recurrent high-risk neuroblastoma in remission or with limited residual disease after best available treatment. The bivalent vaccine is intended to...
Tyrosine Kinase Inhibitors May Improve Treatment Outcomes in Children With Philadelphia Chromosome–Like ALL
Using genomic profiling and next-generation sequencing of patients with BCR-ABL1-like B-progenitor acute lymphoblastic leukemia (B-cell ALL) and Philadelphia chromosome–like ALL, researchers recently identified alterations targeting 18 kinase or cytokine receptor genes. They then determined...
Lymphatic Mapping Agent Receives Orphan Drug Designation for Head and Neck Cancers
Navidea Biopharmaceuticals, Inc, recently announced that technetium 99m tilmanocept (Lymphoseek Injection) has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for use in sentinel lymph node detection in patients with cancer of the head and neck. The designation...
Study Identifies Two Novel ALK Mutations Causing Lung Cancer Resistance to ALK Inhibitors
In a recent study investigating alectinib resistance in ALK-positive lung cancers, researchers identified two novel ALK mutations that are sensitive to ceritinib (Zykadia), a next-generation ALK tyrosine kinase inhibitor approved by the FDA earlier this year for advanced non–small cell lung...
AACR’s 2014 Cancer Progress Report Stresses Research Advances and More Federal Funding
The American Association for Cancer Research (AACR) released its 2014 Cancer Progress Report today, which highlights the quickening pace of drug development and approval, especially in molecularly targeted agents that are leading to increased numbers of cancer survivors. However, the report also...
FDA Approves New Indication for Enzalutamide in Metastatic Castration-Resistant Prostate Cancer
The U.S. Food and Drug Administration (FDA) has approved a new indication for the use of enzalutamide (Xtandi) capsules to treat patients with metastatic castration-resistant prostate cancer. The new indication is for men with metastatic castration-resistant prostate cancer who have not received...
FDA Approves Pembrolizumab for Advanced Melanoma
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to the anti–PD-1 antibody pembrolizumab (Keytruda) for the treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs. Pembrolizumab is intended for use following...
FDA 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...
