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Showing 3451 - 3500National Coalition for Cancer Survivorship Honors Richard Pazdur, MD, and Ellen Goodman
On October 21 in Washington, DC, the National Coalition for Cancer Survivorship (NCCS) hosted a reception to honor Richard Pazdur, MD, and Ellen Goodman. Special guest Robert M. Califf, MD, Deputy Commissioner for Medical Products and Tobacco at the U.S. Food and Drug Administration (FDA),...
FDA Approves Trabectedin for Advanced Liposarcoma and Leiomyosarcoma
The U.S. Food and Drug Administration today approved the chemotherapy drug trabectedin (Yondelis) for the treatment of specific soft-tissue sarcomas—liposarcoma and leiomyosarcoma—that are unresectable or metastatic. This treatment is approved for patients who previously received...
Statement From AACR CEO Margaret Foti, PhD, MD (hc), on Vice President Biden’s Call for More Cancer Research
Margaret Foti, PhD, MD (hc), CEO of the American Association for Cancer Research (AACR), issued the following statement regarding Vice President Joe Biden’s call for a “moon shot” to end cancer: “We extend our deepest sympathy to Vice President Biden and his family for the...
FDA Approves Liposomal Irinotecan for Advanced Pancreatic Cancer
The U.S. Food and Drug Administration today approved irinotecan liposome injection (Onivyde), in combination with fluorouracil (5-FU) and leucovorin, to treat patients with metastatic pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy. According to the National...
Inotuzumab Ozogamicin Receives FDA Breakthrough Therapy Designation for Acute Lymphoblastic Leukemia
Pfizer announced that the investigational antibody-drug conjugate inotuzumab ozogamicin received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for acute lymphoblastic leukemia (ALL). The Breakthrough Therapy designation was based on the results of the phase III...
FDA Approves Use of Nivolumab in Advanced Nonsquamous Lung Cancer
The U.S. Food and Drug Administration (FDA) today approved nivolumab (Opdivo) to treat patients with metastatic nonsquamous non–small cell lung cancer (NSCLC) whose disease progressed during or after platinum-based chemotherapy. Nivolumab is a monoclonal antibody that that blocks the...
FDA Approves Expanded Indication for Medical Device to Treat Newly Diagnosed Glioblastoma Multiforme
The U.S. Food and Drug Administration (FDA) today approved an expanded indication for the Optune tumor treating fields device to treat patients with newly diagnosed glioblastoma multiforme. It is given along with the chemotherapy drug temozolomide following standard treatments that include...
ASCO Endorses CHEST Guideline on Treatment of Small Cell Lung Cancer
As reported in the Journal of Clinical Oncology, ASCO has endorsed the current American College of Chest Physicians (CHEST) guideline on treatment of small cell lung cancer, released in 2013. After review of evidence from an updated literature search covering 2011 to March 2015, an ASCO...
FDA Grants Accelerated Approval to Pembrolizumab for Advanced NSCLC
On October 2, 2015, the U.S. Food and Drug Administration (FDA) granted accelerated approval for pembrolizumab (Keytruda) to treat patients with metastatic non–small cell lung cancer (NSCLC) whose disease has progressed after other treatments and with tumors that express programmed cell...
ECC 2015: Atezolizumab in Locally Advanced or Metastatic Urothelial Carcinoma: Results of the IMvigor 210 Study
At the 2015 European Cancer Congress in Vienna, Austria, early results were announced (Abstract 21LBA) from a pivotal phase II study, IMvigor 210, of the investigational cancer immunotherapy atezolizumab (anti–PD-L1; MPDL3280A) in people with locally advanced or metastatic urothelial...
FDA Grants Accelerated Approval to Nivolumab in Combination With Ipilimumab in BRAF V600 Wild-Type, Unresectable, or Metastatic Melanoma
On September 30, 2015, the U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab (Opdivo) in combination with ipilimumab (Yervoy) for the treatment of patients with BRAF V600 wild-type, unresectable, or metastatic melanoma. The FDA is scheduled to make a decision on ...
Preclinical Study Shows Starving Cancer Cells of Cholesterol May Inhibit Tumor Growth and Improve Drug Sensitivity
Drugs that target key proteins involved in cholesterol metabolism could represent a promising new treatment strategy for a broad range of cancers, according to research by Fox Chase Cancer Center investigators. The study, published by Gabitova et al in Cell Reports, reveals that deficiency in the...
FDA Approves New Oral Medication for the Treatment of Refractory Metastatic Colorectal Cancer
The U.S. Food and Drug Administration today approved trifluridine/tipiracil (Lonsurf) for patients with metastatic colorectal cancer who have been previously treated with chemotherapy and biologic therapy and are no longer responding to treatment. The new agent is an oral combination of...
AACR’s Cancer Progress Report Details Major Advances in Cancer and Rising Costs of Treatment
The American Association for Cancer Research (AACR) 2015 Cancer Progress Report highlighted the accelerated pace of the number of U.S. Food and Drug Administration (FDA)-approved targeted therapies over the past 5 years, which reached 52 this year; the dramatic increase in the 5-year survival rate...
FDA Grants Priority Review to Ixazomib for Patients With Relapsed/Refractory Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has granted Priority Review status to the New Drug Application for the investigational oral proteasome inhibitor ixazomib for the treatment of patients with relapsed or refractory multiple myeloma, Takeda Pharmaceuticals announced. The New Drug...
FDA Grants Alectinib Priority Review for ALK‑Positive Lung Cancer
Genentech announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) and granted Priority Review for alectinib, an oral investigational anaplastic lymphoma kinase (ALK) inhibitor, for the treatment of people with ALK-positive,...
FDA Approves Rolapitant for Prevention of Chemotherapy-Induced Nausea and Vomiting
The U.S. Food and Drug Administration (FDA) approved rolapitant (Varubi) to prevent delayed-phase chemotherapy-induced nausea and vomiting. Rolapitant is approved in adults in combination with other antiemetic agents that prevent nausea and vomiting associated with initial and repeat courses of...
FDA Accepts for Priority Review the Biologics License Application for Elotuzumab for the Treatment of Relapsed Multiple Myeloma
Bristol-Myers Squibb and AbbVie today announced that the U.S. Food and Drug Administration has accepted for priority review the Biologics License Application for elotuzumab, an investigational signaling lymphocyte activation molecule (SLAMF7)-directed immunostimulatory antibody, for the...
High Use of Complementary or Alternative Medicines in Older Patients With Cancer
Alternative medicines are widely thought to be at least harmless, and very often helpful, for a wide range of discomforts and illnesses. However, although they’re marketed as “natural,” they often contain active ingredients that can react chemically and biologically with other...
FDA Approves Eltrombopag for Pediatric Patients With Chronic Immune Thrombocytopenia
The U.S. Food and Drug Administration approved eltrombopag (Promacta) for the treatment of thrombocytopenia in pediatric patients aged 1 year and older with chronic immune thrombocytopenia who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. The approval was...
FDA Grants Regular Approval to Brentuximab Vedotin as Post-Transplant Consolidation Therapy for High-Risk Classical Hodgkin Lymphoma
The U.S. Food and Drug Administration has approved brentuximab vedotin (Adcetris) as post–autologous hematopoietic stem cell transplantation consolidation treatment for patients with classical Hodgkin lymphoma at high risk of relapse or progression, Seattle Genetics has announced. The...
ASCO Statement: Improving the Evidence Base for Treating Older Adults With Cancer
Older persons are the fastest growing segment of the U.S. population and account for the majority of cancer diagnoses and deaths and the majority of cancer survivors. However, since this population is underrepresented in clinical trials, the evidence base for treating older patients is poor. As...
Study Finds Underinvestment in Long-Term Cancer Research
Pharmaceutical firms underinvest in long-term research to develop new cancer-fighting drugs due to the greater time and cost required to conduct such research, according to a newly published study authored by Massachusetts Institute of Technology (MIT) economists. These findings were published by...
FDA Grants Orphan Drug Designation to Novel Dactinomycin Formulation for Ewing Sarcoma
The FDA has granted Orphan Drug designation to NanoSmart Pharmaceuticals’ novel formulation of dactinomycin for the treatment of Ewing sarcoma, a rare type of childhood bone cancer. The designation was granted on the basis of a plausible hypothesis that the novel formulation, which uses...
FDA Grants Breakthrough Therapy Designation to Lenvatinib for Metastatic Renal Cell Carcinoma
The U.S. Food and Drug Administration (FDA) granted lenvatinib (Lenvima) Breakthrough Therapy designation for investigational use in patients with advanced or metastatic renal cell carcinoma who were previously treated with a vascular endothelial growth factor (VEGF)-targeted therapy. Lenvatinib...
FDA 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...
