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Showing 1151 - 1200FDA 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...
Aurora Kinase A Inhibitor Alisertib Active in Solid Tumors
In a phase II study reported in The Lancet Oncology, Melichar et al found that the oral aurora kinase A inhibitor alisertib was active in solid tumors, particularly breast cancer and small cell lung cancer. Aurora kinases play central roles in mitosis. Inhibition of aurora kinase A, which is...
No Overall Survival Benefit of Adding Orteronel to Prednisone in Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer
In the phase III ELM-PC 4 trial reported in The Lancet Oncology, Saad et al found that the addition of the CYP 17,20 lyase inhibitor orteronel to prednisone did not improve overall survival in chemotherapy-naive patients with metastatic castration-resistant prostate cancer. Improvement in...
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...
Ibrutinib Active in Previously Untreated and Relapsed/Refractory CLL With TP53 Aberrations
In a phase II study reported in The Lancet Oncology, Farooqui et al found that single-agent ibrutinib (Imbruvica) had good activity in patients with previously untreated or relapse/refractory chronic lymphocytic leukemia (CLL) with TP53 aberrations. Study Details In this single-arm trial, 51...
Supplemental New Drug Application Submitted for Carfilzomib for Relapsed Multiple Myeloma
Amgen and its subsidiary Onyx Pharmaceuticals, Inc, announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for carfilzomib (Kyprolis) to seek approval for the treatment of patients with relapsed multiple myeloma who have received at...
Analysis of Unexplored Part of Human Genome May Lead to Cancer Biomarker Development
A new analysis opens the door to the discovery of thousands of potential new cancer biomarkers, according to a recent study by Iyer et al published in Nature Genetics. Long Noncoding RNA Researchers at the University of Michigan Comprehensive Cancer Center analyzed the global landscape of long...
Expanded Analyses of Phase III MM-398 NAPOLI-1 Study Substantiate Positive Results of MM-398 Combined With Fluorouracil/Leucovorin
Additional analyses from the global phase III NAPOLI-1 study of MM-398 (aka PEP02), a nanoliposomal encapsulation of irinotecan, in metastatic pancreatic cancer were presented by Chen et al in an oral session at the 2015 Gastrointestinal Cancers Symposium (Abstract 234). The primary analysis ...
No Survival Difference for Adjuvant Capecitabine vs 5-FU With or Without Oxaliplatin in Stage III Colon Cancer
In an analysis reported in The Lancet Oncology, Schmoll et al found no difference in survival outcomes with adjuvant capecitabine vs fluorouracil (5-FU)/leucovorin with or without oxaliplatin in patients with stage III colon cancer and no adverse impact of adjuvant oxaliplatin on post-relapse...
ASH 2014: Oral Inhibitor Shows Clinical Activity in Poor-Prognosis AML
An oral targeted drug has shown encouraging activity and tolerable side effects in patients with treatment-resistant or relapsed acute myelogenous leukemia (AML), a poor-prognosis group with few options, reported investigators from Dana-Farber Cancer Institute and The University of Texas MD...
LINE-1 Hypomethylation Associated With Poorer Survival in Microsatellite Instability–High vs Microsatellite-Stable Tumors in Colorectal Cancer
In a study reported in the Journal of the National Cancer Institute, Inamura et al found that hypomethylation in long interspersed nucleotide element-1 (LINE-1) is associated with greater colorectal cancer–specific and overall mortality in high-degree microsatellite instability vs...
Hormone Loss Could Be Involved in Colon Cancer
Some cancers, like breast and prostate cancer, are driven by hormones such as estrogen and testosterone, but to date, there are none that are understood to be driven by the lack of a hormone. New evidence reported by researchers at Thomas Jefferson University, Philadelphia, suggests that human...
Sex Steroid Hormones May Play a Role in the Development of Aggressive Prostate Cancer
Men with higher estradiol-to-testosterone ratios had a substantially reduced risk of aggressive prostate cancer, whereas men with higher ratios of 2-hydroxyestrone to 16α-hydroxyestrone had an increased risk of such cancer, according to the study findings presented by Black et al in Cancer...
Robert S. Miller, MD, FACP, FASCO, Joins ASCO as Medical Director for Society's Institute for Quality
Robert S. Miller, MD, FACP, FASCO, Assistant Professor of Oncology and Oncology Medical Information Officer at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, has been named Medical Director of the Institute for Quality (iQ) of the American Society of Clinical Oncology (ASCO). ...
Pilot Study Evaluates Concurrent Use of Sunitinib and Radiation Therapy in Recurrent High-Grade Glioma
The combination of continuous daily-dosed sunitinib (Sutent) and hypofractionated stereotactic radiation therapy produced acceptable toxicity and “encouraging” 6-month progression-free survival in previously irradiated patients with recurrent high-grade glioma, according to the results...
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...
mTOR Inhibitor Ridaforolimus Shows Activity in Advanced Endometrial Cancer
The oral mTOR inhibitor ridaforolimus was modestly active and reasonably tolerated in women with recurrent or metastatic endometrial cancer, according to the results of a phase II study reported in Gynecologic Oncology. Tsoref et al suggested that it may prove to be an effective therapeutic...
Promising Activity of Ibrutinib Plus Rituximab in High-Risk CLL
In a phase II trial reported in The Lancet Oncology, Burger et al found that the combination of ibrutinib (Imbruvica) and rituximab (Rituxan) showed promising activity and an encouraging safety profile in patients with previously treated or untreated high-risk chronic lymphocytic leukemia (CLL)....
NSAID Use May Reduce Risk of Breast Cancer Recurrence in Overweight and Obese Women
Obesity is associated with a worse breast cancer prognosis and elevated levels of inflammation, including greater cyclooxygenase-2 (COX-2) expression and activity in adipose-infiltrating macrophages. Data from a new study finds that overweight and obese women who regularly used aspirin or other...
Noninvasive Image Texture Analysis May Provide Tumor Heterogeneity Information With Prognostic Potential in NSCLC
Noninvasive quantitative computed tomography–based texture analysis can accurately differentiate the presence of a KRAS mutation from pan–wild-type non–small cell lung cancer (NSCLC), based on the results of a study in PLOS ONE. Weiss et al reported that this tumor heterogeneity...
New Androgen Receptor Inhibitor Shows Activity in Metastatic Castration-Resistant Prostate Cancer
ODM-201 is a novel androgen receptor inhibitor—structurally distinct from enzalutamide (Xtandi)—that acts via high-affinity binding to the androgen receptor and inhibition of receptor nuclear translocation. In the phase I/II ARADES trial reported in The Lancet Oncology, Fizazi et al...
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...
Adding Rilotumumab to First-Line Chemotherapy May Benefit Patients With Advanced Gastric or Esophagogastric Junction Adenocarcinoma
Hepatocyte growth factor (HGF) and its receptor MET have been found to promote the proliferation, migration, and survival of tumor cells and to play a role in gastric cancer. In a phase II study reported in The Lancet Oncology, Iveson et al found evidence of benefit from adding the anti-HGF...
Tumor Microenvironment of Metastasis Score Independently Predicts Distant Metastasis in Estrogen Receptor–Positive/HER2-Negative Breast Cancer
Tumor microenvironment of metastasis (TMEM) consists of direct contact between a macrophage, an endothelial cell, and a tumor cell. In a case-control study reported in the Journal of the National Cancer Institute, Rohan et al found that TMEM score was an independent predictor of distant metastasis...
Priming Pancreatic Cancer Cells With a Vaccine May Allow Them to Respond to Immunotherapy
Pancreatic ductal adenocarcinoma is considered a “nonimmunogenic” neoplasm and does not typically respond to immunotherapy, in part due to a complex tumor microenvironment that provides a formidable barrier to immune infiltration and function. A new study by Lutz et al has found that by ...
ASCO 2014: Lenvatinib Yields High Response Rates, Delays Progression in Patients With Radioiodine-Resistant Differentiated Thyroid Cancer
A phase III, multicenter, double-blind, placebo-controlled study found that the oral targeted drug lenvatinib is highly effective among patients with differentiated thyroid cancer resistant to standard radioiodine therapy. “The main result is an extraordinary improvement in progression-free...
Early Study Shows Improved Survival With Radioimmunotherapy/Gemcitabine Combination in Patients With Advanced Pancreatic Ductal Cancer
A randomized phase Ib study of a combination of low radiosensitizing doses of gemcitabine and fractionated doses of 90Y-clivatuzumab tetraxetan in patients with metastatic pancreatic ductal cancer who had received at least two prior systemic therapies, has found a significant survival advantage in...
Novel Targeted Drug May Provide a New Treatment Option for Patients With Recurrent Pigmented Villonodular Synovitis
According to early results from a phase I study, a new targeted drug, PLX3397, appears remarkably active against a rare neoplastic joint disorder known as pigmented villonodular synovitis. The study evaluated patients whose disease had progressed despite all other available therapies. More than...
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...
European Phase II Study Indicates Activity of Enzalutamide in Hormone-Naive Prostate Cancer
As reported in The Lancet Oncology by Tombal et al, a single-arm phase II trial of the androgen receptor inhibitor enzalutamide (Xtandi) has shown that the agent is active in suppressing disease and well tolerated in men with hormone-naive prostate cancer. In this ongoing trial, 67 men with...
Panitumumab Not Inferior to Cetuximab in Overall Survival in Chemotherapy-Refractory Wild-Type KRAS Metastatic Colorectal Cancer
In the open-label noninferiority phase III ASPECCT trial reported in The Lancet Oncology, Price et al found that anti-EGFR monoclonal antibody treatment with panitumumab (Vectibix) produced a noninferior overall survival outcome vs cetuximab (Erbitux) in patients with chemotherapy-refractory...
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...
MET Immunohistochemistry Expression Is Best Predictor of Benefit From Addition of Onartuzumab to Erlotinib in Advanced NSCLC
A recent phase II study showed progression-free survival and overall survival benefits with the addition of onartuzumab (an antibody directed against MET, a receptor kinase that binds hepatocyte growth factor [HGF]) to erlotinib (Tarceva) in the subset of patients with advanced non–small cell ...
Higher Macrophage Inhibitory Cytokine-1 Levels Associated With Increased Risk of Colorectal Cancer
It is known that chronic inflammation plays a role in the development of colorectal cancer. In a study reported in the Journal of the National Cancer Institute, Mehta et al evaluated the association of the novel plasma inflammatory biomarker macrophage inhibitory cytokine-1 (MIC-1; growth...
Researchers Identify Biomarker for Noncancerous Pancreatic Cysts
Researchers at the Indiana University School of Medicine have discovered a highly accurate, noninvasive test to identify benign pancreatic cysts, which could spare patients the cost and risk of surveillance or potentially dangerous surgical intervention. The findings are reported in the Journal of...
Angiotensin System Inhibitors Improve Survival in Hypertensive Patients With Metastatic Renal Cell Carcinoma
According to a retrospective study, the use of angiotensin system inhibitors, such as lisinopril, captopril, and losartan, improved the survival of patients with metastatic renal cell carcinoma by 9 months, compared with patients who were not receiving these types of agents. Survival was even...
No Increased Risk of Local Recurrence After Breast-Conserving Surgery in Triple-Negative Breast Cancer in Single-Center Study
Triple-negative breast cancer may be considered a relative contraindication to breast-conserving surgery. In a study reported in JAMA Surgery, Gangi et al from Cedars-Sinai Medical Center in Los Angeles assessed outcomes in a large cohort of women undergoing breast-conserving surgery at their...
Imprime PGG Added to Chemoimmunotherapy Shows Improved Outcomes in Advanced Lung Cancer Patients
The addition of Imprime PGG, a type of immunotherapy, to chemoimmunotherapy with carboplatin, paclitaxel, and cetuximab (Erbitux) resulted in improved response rates and overall survival rates in patients with late-stage, non–small cell lung cancer (NSCLC), according to the results of a phase ...
Julie M. Vose, MD, MBA, FASCO, Elected ASCO President for 2015-2016 Term
Julie M. Vose, MD, MBA, FASCO, has been elected President of the American Society of Clinical Oncology (ASCO) for a 1-year term beginning in June 2015. She will take office as President-Elect during the ASCO Annual Meeting in Chicago in June 2014. Additionally, four new members were elected to the...
No Overall Survival Benefit With Addition of Sunitinib to Prednisone in Metastatic Castration-Resistant Prostate Cancer
In a phase III trial reported in the Journal of Clinical Oncology, Michaelson et al assessed the addition of the antiangiogenesis agent sunitinib (Sutent) to prednisone in patients with progressive metastatic castration-resistant prostate cancer after docetaxel-based chemotherapy. No...
Digital Breast Tomosynthesis Increases Cancer Detection and Reduces Recall Rates
Compared to traditional mammography, three-dimensional (3D) mammography—known as digital breast tomosynthesis—found 22% more breast cancers and led to fewer call-backs in a large screening study at the Hospital of the University of Pennsylvania, researchers reported today at the 99th...
Brentuximab Vedotin Plus ABVD or AVD Is Highly Active in Newly Diagnosed Hodgkin Lymphoma
Brentuximab vedotin (Adcetris) is active in patients with relapsed/refractory Hodgkin’s lymphoma. In a phase I study reported in The Lancet Oncology, Anas Younes, MD, of Memorial Sloan-Kettering Cancer Center (formerly of The University of Texas MD Anderson Cancer Center), and colleagues...
Assay-Sensitive Treatment Improves Outcomes in Recurrent Ovarian Cancer
The use of assay-sensitive treatment significantly improved both progression-free survival and overall survival compared with nonsensitive treatment in women with recurrent ovarian cancer, according to the results of a prospective clinical trial reported in Gynecologic Oncology. Thomas Rutherford,...
No Progression-Free Survival Difference With First-Line Axitinib vs Sorafenib in Metastatic Renal Cell Carcinoma
In a phase III trial reported in The Lancet Oncology, Thomas E. Hutson, DO, PharmD, of Baylor Sammons Cancer Center and colleagues compared the second-generation VEGFR inhibitor axitinib (Inlyta) with sorafenib (Nexavar) as first-line treatment of metastatic renal cell carcinoma. There was no...
Phase II Study Supports Axitinib Dose Titration in Select Treatment-Naive Metastatic Renal Cell Carcinoma Patients
Axitinib plasma exposure may correlate with efficacy in metastatic renal cell carcinoma, according to population pharmacokinetic data. In a phase II study reported in The Lancet Oncology, Brian I. Rini, MD, of the Cleveland Clinic, and colleagues evaluated the effects of axitinib dose titration in...
New Nanopharmaceutical May Be Able to Overcome Resistance to Antiangiogenic Treatment
The nanopharmaceutical CRLX101, a novel inhibitor of topoisomerase-1 and hypoxia-inducible factor (HIF)-1 alpha, may be capable of overcoming resistance of tumors to antiangiogenic agents, according to preclinical and early clinical studies that have evaluated CRLX101 in combination with...
Targeted Investigational Therapy Has Potential to Overcome Crizotinib Resistance in Lung Cancers
The investigational drug PF-06463922 may have the potential to become a new treatment option for patients who have lung cancer harboring abnormalities in the ALK gene, according to preclinical results (Abstracts A277, PR10/B107, and C253) presented at the AACR-NCI-EORTC International Conference on...
Dual-Stained Cytology Has Greater Sensitivity and Comparable Specificity vs Pap Cytology for High-Grade Cervical Intraepithelial Neoplasia
Pap cytology is more specific but less sensitive than human papillomavirus (HPV) testing for the detection of high-grade cervical intraepithelial neoplasia (CIN2+). In the pan-European PALMS study, reported in the Journal of the National Cancer Institute, Hans Ikenberg, MD, of CytoMol in...
Researchers Identify Potential New Drug for Inherited Cancer
Scientists from The Scripps Research Institute have identified a new drug candidate for an inherited form of cancer with no known cure. The new study showed the drug candidate—known as FRAX97—slowed the proliferation and progression of tumor cells in animal models of neurofibromatosis...
Men With Advanced Prostate Cancer Worry More About Burdening Family and Friends Than Dying, Survey Finds
Men with advanced prostate cancer are now living longer than ever, and it is estimated that one in six U.S. men will be diagnosed with prostate cancer in their lifetime. However, little research has been conducted to understand the psychosocial needs of these men and their caregivers after...
