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...
Immune cells engineered to seek out and attack a type of deadly brain cancer were found to be safe and effective at controlling tumor growth in mice that were treated with these modified cells, according a team from the Perelman School of Medicine at the University of Pennsylvania and the Novartis...
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...
Findings from a federally funded study suggest that patients with locally advanced kidney cancer should not be treated with either adjuvant sorafenib (Nexavar) or sunitinib (Sutent). The average period to disease recurrence was similar between those who received sorafenib or sunitinib after surgery ...
An analysis of data on roughly 87,500 men treated for prostate cancer since 2005 found a notable increase in higher-risk cases of the disease between 2011 and 2013. The retrospective analysis of patient data found the proportion of men diagnosed with intermediate- and high-risk disease increased by ...
Findings from a small prospective study suggest that androgen receptor V7 (or AR-V7) status does not significantly affect response to taxane chemotherapy in men with metastatic castration-resistant prostate cancer. Treatment outcomes were largely similar for the 17 patients with...
As reported in the Journal of Clinical Oncology by Wang et al, the incidence of late toxicity among patients with extremity soft-tissue sarcoma receiving preoperative image-guided radiotherapy to a reduced target volume in the phase II Radiation Therapy Oncology Group (RTOG) 0630 trial was lower...
Decades after undergoing cranial irradiation for childhood cancer, St. Jude Children's Research Hospital investigators found that adult survivors of pediatric cancer remain at risk for pituitary hormone deficiencies, which may diminish their health and quality of life. Chemaitilly et al published...
A frailty score predicts mortality and the risk of toxicity in elderly patients with multiple myeloma and can be used to determine more suitable therapies for these patients, the International Myeloma Working Group reported in Blood. “Chronologic age, performance status, and physician's...
A phase II, open-label study evaluating the efficacy of brentuximab vedotin (Adcetris), an anti-CD30 antibody-drug conjugate, found that among 48 evaluable patients with CD30-positive diffuse large B-cell lymphoma, 21 (44%) had objective responses. This total included 8 patients (17%) with complete ...
“Risk assessment in Hodgkin lymphoma is continuously evolving and promises even greater precision and specific clinical relevance in the future,” Joseph M. Connors, MD, stated in Blood. Dr. Connors is Clinical Professor, British Columbia Cancer Agency Centre for Lymphoid Cancer and the...
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...
Researchers at Roswell Park Cancer Institute (RPCI) have uncovered new information that may begin to explain why many African American women are more likely to be diagnosed with aggressive, often deadly forms of breast cancer. Their findings also strengthen evidence that increased dietary folate...
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. ...
Pancreatic cancer affects approximately 46,000 people each year in the United States, and ranks fourth among the leading causes of cancer-related deaths. Only about 6% of individuals with pancreatic cancer will live 5 years after their diagnosis. One reason for this high mortality rate is the lack...
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...
Chemotherapy resistance is one of the most formidable obstacles to treating acute lymphoblastic leukemia (ALL), the most common form of childhood cancer. Now researchers at Children’s Hospital Los Angeles (CHLA) have designed and developed a new protein-based therapy that may prove highly...
According to researchers at the Johns Hopkins Kimmel Cancer Center, testosterone, which is generally thought to be a feeder of prostate cancer, has been found to suppress some advanced prostate cancers. The hormone may also reverse resistance to testosterone-blocking drugs used to treat prostate...
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...
In a study reported in The New England Journal of Medicine, Jaiswal et al found somatic mutations associated with hematologic cancers at increasing frequency with increasing age, with presence of the mutations being associated with increased risk of hematologic cancers, all-cause mortality,...
In a study reported in The New England Journal of Medicine, Genovese et al found that clonal hematopoiesis with somatic mutations is increasingly common with greater age and is associated with increased risk of hematologic cancer. The presence of such clonal hematopoiesis in apparently healthy...
A genomic study of cancer patients previously treated with chemotherapy or radiation therapy found that TP53 mutations may play a role in the development of treatment-related acute myeloid leukemia (AML) and myelodysplastic syndrome, according to a report by Wong et al in Nature. However, the...
A somatic mutation in the ATRX gene has recently been identified as a potential molecular marker for gliomas, neuroblastomas, and pancreatic neuroendocrine tumors. Now, researchers at the Perelman School of Medicine at the University of Pennsylvania have found that the same mutated gene may serve...
A simple change to a two-drug therapy for metastatic pancreatic cancer provides similar cancer control while significantly improving quality of life and reducing the cost of care, according to data reported by researchers at the The Ohio State University Comprehensive Cancer Center – Arthur...
A large population-based analysis of women 65 and older in the United States diagnosed with endometrial cancer has found that women with metabolic syndrome—characterized by low HDL cholesterol, hypertension, high triglycerides, and elevated waist circumference—have an increased risk of...
Updated results from TRIBE, an Italian phase III study of patients with metastatic colorectal cancer, indicate that FOLFOXIRI (leucovorin, fluorouracil [5-FU], oxaliplatin, irinotecan) chemotherapy in combination with bevacizumab (Avastin) is superior to the standard FOLFIRI (leucovorin, 5-FU,...
A prospective analysis of data from a phase III study of patients newly diagnosed with metastatic colorectal cancer indicates that patients with higher vitamin D levels have better outcomes after treatment with chemotherapy and targeted therapy. The median overall survival for patients with the...
Patients with new cases of cancer face a heightened risk of stroke in the months immediately following their diagnoses, with that risk escalating with the aggressiveness of their disease, according to a new study from researchers at Weill Cornell Medical College and Memorial Sloan Kettering Cancer...
After performing whole-genome sequencing on patients found to have BRCA1or BRCA2 mutations as well as on those that were not carriers of either mutation, researchers found cancer risk–related potentially pathogenic variants in those without BRCA mutations. While the results highlight the ...
In a phase II study reported in The Lancet Oncology, Topp et al found that the bispecific CD19-directed CD3 T-cell engager (BiTE) blinatumomab (Blincyto) was highly active in adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Blinatumomab binds to CD19 expressed ...
The molecular determinants of benefit from immune checkpoint inhibitor treatment have not been characterized. In a study reported in The New England Journal of Medicine, Snyder et al found that benefit of the anti–cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibodies ipilimumab (Yervoy) and...
Today’s approval by the U.S. Food and Drug Administration (FDA) of olaparib (Lynparza) occurred concurrently with that of a companion diagnostic, BRACAnalysis CDx. This genetic test is designed to detect the presence of mutations in the BRCA genes in blood samples from patients with ovarian...
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to olaparib (Lynparza) for women with advanced ovarian cancer with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer, as detected by an FDA-approved test, who have been treated with three ...
In a phase II study, the histone deacetylase inhibitor pracinostat demonstrated significant clinical activity in combination with azacitadine in elderly patients with newly diagnosed acute myeloid leukemia (AML). Interim data from 33 evaluable patients were presented at the 56th American Society of ...
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...
Common variations in four genes related to brain inflammation or cells′ response to damage from oxidation may contribute to the problems with memory, learning, and other cognitive functions seen in children treated for acute lymphoblastic leukemia (ALL), according to a study presented at the...
Outcomes in children with T-cell acute lymphoblastic leukemia (ALL), which has traditionally been considered a poor-prognosis cancer, are better than expected, even for the early thymic precursor (ETP) phenotype, according to investigators from the Children’s Oncology Group (COG) who...
Although the data are preliminary, single-agent AG-221 therapy targeted to the IDH2 mutation holds great promise as a nonchemotherapy approach for the treatment of advanced hematologic malignancies, including relapsed/refractory acute myelogenous leukemia (AML) and untreated AML. The findings were...
A phase II study investigating the potential of the drugs azacitidine and lenalidomide (Revlimid) demonstrated that the two therapies in combination may be an effective frontline treatment regimen for patients with higher-risk forms of myelodysplastic syndrome and acute myeloid leukemia (AML). The...
As more experience is gained with the use of genetically engineered chimeric antigen receptor (CAR) T cells in pediatric patients with relapsed/refractory acute lymphoblastic leukemia (ALL), the data continue to be highly encouraging. To date, 36 of 39 pediatric ALL patients (92%) treated with...
Results from a large prospective study suggest that children and young adults with acute lymphocytic leukemia (ALL) may respond better to a chemotherapy regimen pioneered in pediatric patients. The findings were presented at the 56th American Society of Hematology (ASH) Annual Meeting and...
Patients with human immunodeficiency virus (HIV)-related relapsed/refractory lymphoma can safely undergo autologous hematopoietic cell transplant, according to results of a phase II multicenter trial. At many centers, patients with HIV-related lymphoma are currently excluded from this potentially...
The U.S. Food and Drug Administration (FDA) today approved a new use for ruxolitinib (Jakafi) to treat patients with polycythemia vera, a chronic type of bone marrow disease. Ruxolitinib, a JAK inhibitor, is the first drug approved by the FDA for this condition. Polycythemia vera occurs when too...
In a phase Ib/II study of patients with relapsed or refractory acute myeloid leukemia (AML), the addition of vosaroxin to cytarabine demonstrated antileukemic activity and an acceptable risk-benefit profile, according to a study by Lancet et al in Haematologica. Based on the findings from this...
In a phase III trial reported in The New England Journal of Medicine, Wagner et al found that use of two units vs one unit of umbilical cord blood in hematopoietic stem cell transplantation did not improve 1-year overall survival in children and adolescents with hematologic cancers. Use of...
New evidence that immune checkpoint inhibitors may work in glioblastoma and brain metastases was presented today at the ESMO Symposium on Immuno-Oncology 2014 in Geneva (Abstract 1O). The novel research shows that brain metastases of tumor infiltrating lymphocytes, providing an immunoactive...
Results from the ARMOR2 of the anticancer drug galeterone shows that it is successful in lowering prostate-specific antigen (PSA) levels in men with a variant form castration-resistant prostate cancer. The findings, presented at the 26th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer...
Researchers have found that patients with an advanced form of kidney cancer, for which there is no standard treatment and a very poor prognosis, respond well to a combination of two existing anticancer drugs. The combination of bevacizumab (Avastin) and erlotinib (Tarceva) produced excellent...
A phase I trial of the first drug designed to inhibit the cancer-causing activity of a mutated enzyme known as isocitrate dehydrogenase (IDH) 1, which is involved in cell metabolism, has shown clinical activity in patients with advanced acute myeloid leukemia (AML) with the IDH1 mutation. The...
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...