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Showing 3501 - 3550FDA Approves Carfilzomib Combination for Patients With Relapsed Multiple Myeloma
The U.S. Food and Drug Administration (FDA) approved carfilzomib (Kyprolis) in combination with lenalidomide (Revlimid) and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received one to three prior lines of therapy. The approval was based on a demonstration of ...
FDA Approves Sonidegib for Locally Advanced Basal Cell Carcinoma
The U.S. Food and Drug Administration (FDA) approved sonidegib (Odomzo) for the treatment of patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy or those who are not candidates for surgery or radiation therapy. The approval was based on...
FDA Grants Orphan Drug Designation to Melphalan for Cholangiocarcinoma
Delcath Systems, Inc, today announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug designation to melphalan for the treatment of cholangiocarcinoma. Cholangiocarcinoma is recognized by the FDA as an orphan disease,...
Study Identifies Mechanism Fueling Growth of Pancreatic and Prostate Cancer Cells
UCLA Jonsson Cancer Center scientists have identified a new mechanism that delivers a key substance that fuels the growth of pancreatic and prostate cancer cells, a finding that offers new hope in the fight against two of the deadliest forms of the disease. Their findings were published by...
Adverse Event Reporting System Indicates Renal Toxic Effects With BRAF Inhibitors Vemurafenib and Dabrafenib
In an analysis of FDA Adverse Event Reporting System data reported in JAMA Oncology, Jhaveri et al found that the BRAF inhibitors vemurafenib (Zelboraf) and dabrafenib (Tafinlar) were associated with nephrotoxicity. Their findings suggest a need to monitor renal function and electrolyte levels ...
FDA Grants Orphan Drug Designation to Anti‑Tropomyosin Drug for Neuroblastoma
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to Novogen Limited’s chemotherapy candidate drug Anisina for neuroblastoma. Anisina is a small molecule belonging to a family of compounds called anti-tropomyosins. It has been designed to inhibit Tpm3.1, a...
FDA Approves Gefitinib for EGFR-Mutated Metastatic Non–Small Cell Lung Cancer
The U.S. Food and Drug Administration (FDA) has approved gefitinib (Iressa) for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an...
Daratumumab Expanded Access Program Open to Eligible U.S. Patients With Heavily Pretreated Multiple Myeloma
Janssen Biotech, Inc, announced the opening of a daratumumab expanded access program for eligible U.S. patients. Daratumumab is an investigational human anti-CD38 monoclonal antibody being evaluated in clinical trials as a treatment for patients with multiple myeloma. The multicenter, open-label...
Mapping Genetic Mutations in Cutaneous Melanoma
Researchers have a significantly better understanding of the genetic alterations found in cutaneous melanoma as part of a multi-institution, international effort of The Cancer Genome Atlas (TCGA). The study, published in Cell, refined and revealed new molecular subgroups of patients who could...
Analysis Shows Advantage for Picture-Based vs Text-Based Warnings on Cigarette Packs
Pictures illustrating the dangers of cigarette smoking were more effective at strengthening people’s intentions to quit smoking than text warnings, a University of North Carolina at Chapel Hill analysis of multiple research studies has found. These findings were published by Noar et al in...
ASCO 2015: NCI-MATCH Trial Links Targeted Drugs to Genetic Abnormalities
Investigators for the nationwide trial NCI-MATCH: Molecular Analysis for Therapy Choice announced at the 2015 ASCO Annual Meeting in Chicago that the precision medicine trial will open to patient enrollment in July. The trial seeks to determine whether targeted therapies for people whose tumors...
ASCO 2015: Investigational ALK Inhibitor Demonstrates Promising Overall Response Rates in Patients With Advanced ALK-Positive NSCLC
The oral investigational anaplastic lymphoma kinase (ALK) inhibitor alectinib shrank tumors in almost half of patients with advanced ALK-positive non–small cell lung cancer (NSCLC) whose disease had progressed following crizotinib (Xalkori) treatment. Positive results from two clinical...
ASCO 2015: ASCO Announces First-Ever Clinical Trial
ASCO announced its first-ever clinical trial, which will offer patients with advanced cancer access to molecularly targeted cancer drugs and collect “real-world” data on clinical outcomes, to help learn the best uses of these drugs outside of indications approved by the U.S. Food and...
ASCO 2015: JAK Inhibitor Pacritinib Proves Effective for Easing Symptoms of Myelofibrosis
Findings from the PERSIST-1 study of patients with myelofibrosis show that the JAK inhibitor pacritinib is significantly more effective than best available therapy, which includes a range of off-label treatments, for easing the symptoms of myelofibrosis. At a landmark analysis at 24 weeks of...
ASCO 2015: First-in-Class Targeted Drug Daratumumab Is Effective as Single Agent in Heavily Treated Multiple Myeloma
“Daratumumab monotherapy produced unprecedented overall responses that deepened over time” in a phase II trial among patients with heavily treated multiple myeloma, study author Saad Zafar Usmani, MD, reported at a press conference at the 2015 ASCO Annual Meeting. Dr. Usmani, a...
First-in-Class Antibody Mixture Shows Clinical Activity Against Treatment-Resistant, Advanced Colorectal Cancer
Patients with advanced colorectal tumors without mutations in the RAS genes derive substantial benefit from anti-EGFR (epidermal growth factor receptor) therapies; however, the disease eventually progresses, leaving these patients with few alternative therapeutic options. Over the past decade, some ...
FDA Fast Track Designation Granted to AG-120 for Treatment of Patients With IDH1-Mutated Acute Myeloid Leukemia
The U.S. Food and Drug Administration had granted Fast Track designation to AG-120 for the treatment of patients with acute myeloid leukemia who harbor an isocitrate dehydrogenase-1 (IDH1) mutation. Agios Pharmaceuticals’ AG-120 is a first-in-class, oral, selective, potent inhibitor of the...
Sacituzumab Govitecan Receives Fast Track Designation for Non–Small Cell Lung Cancer Therapy
The U.S. Food and Drug Administration has granted Fast Track designation to Immunomedics’ lead antibody-drug conjugate sacituzumab govitecan (IMMU-132) for the treatment of patients with relapsed/refractory metastatic non–small cell lung cancer (NSCLC) who have failed two prior lines of ...
FDA Grants Fast Track Designation to Evofosfamide for Advanced Pancreatic Cancer
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of evofosfamide (TH-302), administered in combination with gemcitabine, for previously untreated patients with metastatic or locally advanced unresectable pancreatic cancer. Evofosfamide is an...
Cobas KRAS Mutation Test Receives FDA Approval
Roche announced that the U.S. Food and Drug Administration (FDA) has approved the cobas KRAS Mutation Test for diagnostic use. The real-time polymerase chain reaction (PCR) test is designed to identify KRAS mutations in tumor samples from patients with metastatic colorectal cancer and aid...
Venetoclax Receives Breakthrough Therapy Designation in Relapsed/Refractory CLL With 17p Deletion
The U.S. Food and Drug Administration has granted Breakthrough Therapy designation to AbbVie’s investigational agent venetoclax (ABT-199) for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) in patients with the 17p deletion. Venetoclax is an investigational oral...
FDA Accepts Supplemental Biologics License Application for Nivolumab in Patients With Previously Untreated Advanced Melanoma
The U.S. Food and Drug Administration (FDA) has accepted for filing and review Bristol-Myers Squibb’s supplemental Biologics License Application (sBLA) for nivolumab (Opdivo) for the treatment of previously untreated patients with unresectable or metastatic melanoma. The FDA also granted...
FDA Approves Ramucirumab for Metastatic Colorectal Cancer
The U.S. Food and Drug Administration today approved ramucirumab (Cyramza) for use in combination with FOLFIRI (leucovorin, fluorouracil, irinotecan) for the treatment of patients with metastatic colorectal cancer whose disease has progressed on a first-line bevacizumab (Avastin)-, oxaliplatin-,...
FDA Announces Clinical Trial Endpoints for Approval of Non–Small Cell Lung Cancer Drugs
This week, the U.S. Food and Drug Administration (FDA) released its guidance for industry document Clinical Trial Endpoints for the Approval of Non–Small Cell Lung Cancer Drugs and Biologics, which allows companies to use several types of clinical trial endpoints, including overall survival...
Crizotinib Receives Breakthrough Therapy Designation for the Treatment of ROS1-Positive Non–Small Cell Lung Cancer
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to crizotinib (Xalkori) for the potential treatment of patients with ROS1-positive non–small cell lung cancer (NSCLC). Crizotinib currently is approved in the United States for the treatment of patients...
AACR 2015: Pembrolizumab Safe, With Signs of Clinical Benefit, for Patients With Malignant Pleural Mesothelioma
Pembrolizumab (Keytruda) was safe, tolerable, and yielded robust antitumor responses in patients with malignant pleural mesothelioma, according to data from the phase Ib KEYNOTE-028 clinical trial presented at the AACR Annual Meeting 2015, held April 18 to 22 in Philadelphia (Abstract CT103)....
Study Finds Oncology Drug Pricing Models ‘Not Rational’
A statistical analysis of 51 oncology drugs approved by the U.S. Food and Drug Administration (FDA) between January 1, 2009, and December 31, 2013, has found that cancer drug prices are rising faster than the prices in other sectors of health care and that the high cost of the drugs is not...
FDA Grants Breakthrough Therapy Designation to Rucaparib in Advanced Ovarian Cancer With BRCA Mutations
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Clovis Oncology’s investigational agent rucaparib as monotherapy treatment of advanced ovarian cancer in patients who have received at least two lines of prior platinum-containing therapy, with...
Addition of Bevacizumab to Chemotherapy Extends Survival in Women With Platinum-Sensitive Recurrent Ovarian Cancer
In a phase III study of women with ovarian cancer, researchers found that the addition of bevacizumab (Avastin) to standard chemotherapy extended median overall survival by 5 months compared to standard chemotherapy alone. The bevacizumab combination was also associated with a significant...
FDA Grants Priority Review to Carfilzomib Supplemental New Drug Application for Relapsed Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has accepted Amgen’s supplemental New Drug Application (sNDA) for carfilzomib (Kyprolis) injection for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. The sNDA is designed to support the...
Annual ASCO Report Shows Widespread Disturbance in Oncology Practice, Amid Growing Patient Demand and Administrative Burden
The U.S. cancer care system faces tremendous turbulence while dealing with growing numbers of cancer patients and survivors, mounting pressures to control rising health-care costs, and widespread oncology practice transformation, reports a new study by the American Society of Clinical Oncology...
FDA Approves Dinutuximab Combination for Pediatric Patients With High-Risk Neuroblastoma
The U.S. Food and Drug Administration has approved dinutuximab (Unituxin) as part of first-line therapy for pediatric patients with high-risk neuroblastoma. Dinutuximab, a chimeric monoclonal antibody that binds to the surface of neuroblastoma cells, is being approved for use as part of a...
Neoadjuvant Chemotherapy for Breast Cancer Increases Chances of Lumpectomy, Decreases Chances of Mastectomy
Patients with larger malignant tumors of the breast who undergo chemotherapy before a breast cancer operation are more likely to undergo a lumpectomy than a mastectomy, according to a study published by Killelea et al in the Journal of the American College of Surgeons. Study investigators from...
FDA Approves First Biosimilar Product Filgrastim‑Sndz
The U.S. Food and Drug Administration (FDA) today approved filgrastim-sndz (Zarxio), the first biosimilar product approved in the United States. A biosimilar product is a biologic product that is approved based on a showing that it is highly similar to an already-approved biologic. The biosimilar...
Study Finds Websites That Market Personalized Cancer Care Services Overemphasize Benefits
A recent analysis of 55 Internet websites marketing a broad range of tests and services that promise the ability to personalize cancer treatment has found that the websites often overemphasize their purported benefits and downplay their limitations. In addition, the study results show that the...
FDA Approves Nivolumab to Treat Metastatic Squamous Non–Small Cell Lung Cancer
The U.S. Food and Drug Administration (FDA) today approved the PD-1 inhibitor nivolumab (Opdivo) for the treatment of patients with metastatic squamous non–small cell lung cancer (NSCLC) who have progressed on or after platinum-based chemotherapy. Nivolumab is a monoclonal antibody that binds ...
Early Study Shows Cabazitaxel May Be More Effective Than Docetaxel in Some Patients With Advanced Prostate Cancer
In a new study reported by de Leeuw et al in Clinical Cancer Research, researchers found that the novel taxane cabazitaxel (Jevtana) has properties that could make it more effective than docetaxel in some patients with advanced prostate cancer. This hypothesis is currently being tested in a phase...
Human Reovirus Formulation Receives FDA Orphan Drug Designation for Fallopian Tube Cancer
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation for Oncolytics Biotech’s proprietary formulation of the human reovirus (Reolysin) for the treatment of fallopian tube cancer. The designation was granted on the basis of the company's December 2014 application for ...
FDA Grants Breakthrough Therapy Designation to EBV-Targeted T Cells for Treatment of EBV-Associated Lymphoproliferative Disease
The U.S. Food and Drug Administration has granted Breakthrough Therapy designation to Memorial Sloan Kettering Cancer Center and Atara Biotherapeutics’ optioned cytotoxic T lymphocytes activated against Epstein-Barr virus (EBV-CTL) in the treatment of patients with rituximab...
FDA Approves Panobinostat Combination for the Treatment of Multiple Myeloma
The U.S. Food and Drug Administration (FDA) today approved panobinostat (Farydak) in combination with bortezomib (Velcade) and dexamethasone for the treatment of patients with multiple myeloma. Panobinostat is the first histone deacetylase (HDAC) inhibitor approved to treat multiple myeloma. It is...
FDA Analysis Explores Relationship Between Response Rate and Survival at Trial and Patient Levels in Advanced NSCLC Studies
In a U.S. Food and Drug Administration (FDA) analysis of randomized trials in advanced non–small cell lung cancer (NSCLC) reported in the Journal of Clinical Oncology, Blumenthal et al found a strong correlation between response rate and progression-free survival at the trial level and a...
FDA Grants Cobimetinib Priority Review for Use in Combination With Vemurafenib in Advanced Melanoma
The U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for Genentech’s New Drug Application (NDA) for cobimetinib in combination with vemurafenib (Zelboraf) for the treatment of people with BRAF V600 mutation–positive advanced melanoma. The FDA will make a...
FDA Approves Lenalidomide in Combination With Dexamethasone for Newly Diagnosed Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has expanded the existing indication for lenalidomide (Revlimid) in combination with dexamethasone to include patients newly diagnosed with multiple myeloma. Lenalidomide plus dexamethasone was previously approved in June 2006 for use in multiple myeloma...
Early Study Suggests Olaparib May Be Effective in Ovarian Cancers Expressing High Levels of POLQ
Last December, the U.S. Food and Drug Administration (FDA) approved olaparib (Lynparza) in the treatment of advanced ovarian cancer in women with BRCA1 or BRCA2 gene mutations. Now, a laboratory study by Ceccaldi et al has found that the drug may also be effective in breast and ovarian tumors that...
FDA Approves Lenvatinib for Progressive Radioiodine-Refractory Differentiated Thyroid Cancer
The U.S. Food and Drug Administration (FDA) today granted approval to lenvatinib (Lenvima) to treat patients with progressive, differentiated thyroid cancer whose disease progressed despite receiving radioactive iodine therapy. Lenvatinib is a tyrosine kinase inhibitor that binds to multiple sites...
FDA Grants Orphan Drug Designation to Human Reovirus Formulation for the Treatment of Ovarian Cancer
Oncolytics Biotech, Inc, a clinical-stage biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics, has announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation for its proprietary formulation of the human reovirus...
Widespread Use of Docetaxel Preceded Phase III Evidence of Usefulness in Patients With Metastatic Prostate Cancer
Docetaxel was being widely used by patients with metastatic prostate cancer before phase III evidence that it was more effective than standard-of-care for patients with castration-resistant prostate cancer, according to an analysis of Medicare claims from before and after the trial results and...
Study Shows Immunosuppressives, Chemotherapy May Reactivate Hepatitis B
Individuals previously infected with the hepatitis B virus (HBV) that receive chemotherapy or immunosuppressive treatment may be at risk of reactivating the virus, according to a report published by Di Bisceglie et al in Hepatology. Reactivation of HBV can be fatal, and researchers suggest routine...
FDA Approves Palbociclib in Combination With Letrozole for Advanced Breast Cancer
The U.S. Food and Drug Administration has granted accelerated approval to palbociclib (Ibrance) in combination with letrozole for the treatment of postmenopausal women with estrogen receptor–positive, HER2-negative metastatic breast cancer who have not yet received an endocrine-based therapy. ...
FDA Grants Priority Review for Trabectedin for the Treatment of Patients With Advanced Soft-Tissue Sarcoma
Janssen Research & Development, LLC, announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for trabectedin to treat patients with advanced soft-tissue sarcoma, including liposarcoma and leiomyosarcoma subtypes, who have...
