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Showing 701 - 750Extended Endocrine Therapy in Postmenopausal Women With Breast Cancer: 2 Years as Effective as 5 Years
An additional 5 years of aromatase inhibitor therapy after 5 years of adjuvant endocrine therapy failed to improve disease-free survival compared with an additional 2 years of aromatase inhibitor therapy in postmenopausal women with hormone receptor–positive breast cancer, according to the results ...
Front-Line Brentuximab Plus AVD vs Standard ABVD in Advanced Hodgkin Lymphoma
FRONT-LINE TREATMENT of advanced Hodgkin lymphoma with brentuximab vedotin (Adcetris) plus doxorubicin/ vinblastine/dacarbazine (A+AVD) achieved superior outcomes compared with the standard four-drug regimen of doxorubicin/bleomycin/vinblastine/dacarbazine (ABVD). The substitution of brentuximab...
Phase II Data for Venetoclax/Ibrutinib Combination in Relapsed or Refractory Chronic Lymphocytic Leukemia
THE COMBINATION of ibrutinib (Imbruvica) plus venetoclax (Venclexta) achieved favorable responses in patients with relapsed or refractory chronic lymphocytic leukemia (CLL), according to initial results of the phase II CLARITY trial presented at the 2017 American Society of Hematology (ASH) Annual ...
Updated Follow-up of ZUMA-1 Confirms Benefit of CAR T-Cell Therapy in Aggressive B-Cell Lymphoma
POSITIVE DATA about chimeric antigen receptor (CAR) T-cell therapy in lymphoma continue to accrue. Long-term follow-up of the pivotal ZUMA-1 trial shows that patients with refractory diffuse large B-cell lymphoma (DLBCL) continue to have durable responses to the CD19-directed CAR T-cell therapy...
Anti–PD-L1 Antibody in Advanced Urothelial Carcinoma After Platinum Failure
As reported in The Lancet Oncology by Patel et al, the anti–programmed cell death ligand 1 (PD-L1) antibody avelumab (Bavencio) produced durable responses in patients with locally advanced or metastatic urothelial carcinoma after failure of platinum-based therapy in two expansion cohorts of...
FDA Announces Approval, CMS Proposes Coverage of Diagnostic Test for Cancer Biomarkers
On November 30, the U.S. Food and Drug Administration (FDA) approved CDx (F1CDx), a breakthrough-designated, next-generation sequencing–based in vitro diagnostic test that can detect genetic mutations in 324 genes and 2 genomic signatures in any solid tumor type. The Centers for Medicare &...
FDA Approves First Biosimilar for the Treatment of Certain Breast and Stomach Cancers
On December 1, 2017, the U.S. Food and Drug Administration (FDA) approved trastuzumab-dkst (Ogivri) as a biosimilar to trastuzumab (Herceptin) for the treatment of patients with breast or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors overexpress the HER2 gene. The...
Ibrutinib in Chronic Graft-vs-Host Disease
On August 2, 2017, ibrutinib (Imbruvica) was approved for treatment of adult patients with chronic graft-vs-host disease after failure of one or more lines of systemic therapy.1,2 This is the first U.S. Food and Drug Administration (FDA)-approved therapy for treatment of chronic graft-vs-host...
Intravenous Rolapitant for Chemotherapy-Induced Delayed Nausea and Vomiting
On October 25, 2017, intravenous (IV) rolapitant (Varubi) was approved for use in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including but not limited to highly...
Walther Cancer Foundation Endows New ASCO Special Award and Lecture for Palliative and Supportive Care
The Walther Cancer Foundation, Inc., a private foundation based in Indianapolis, Indiana, has endowed a new ASCO award and lecture bearing its name to be presented annually at the Palliative and Supportive Care in Oncology Symposium. This grant represents a new foray for the foundation as it...
Vemurafenib in Erdheim-Chester Disease
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On November 6, 2017, vemurafenib (Zelboraf) was granted...
FDA Approves New Oral Solution for Colonoscopy Preparation
The U.S. Food and Drug Administration (FDA) has granted Ferring Pharmaceuticals Inc approval to market a combination sodium picosulfate, magnesium oxide, and anhydrous citric acid oral solution (Clenpiq) for cleansing the colon in adults undergoing a colonoscopy. With availability planned in...
Tandem Autologous/Allogeneic HCT With Maintenance Therapy in High-Risk Myeloma
In a phase II study reported in Blood Advances, Green et al found that tandem autologous/allogeneic hematopoietic cell transplantation (HCT) followed by bortezomib (Velcade) maintenance produced good results in patients with newly diagnosed high-risk multiple myeloma. Poorer outcomes were observed...
FDA Approves Biosimilar for the Treatment of Certain Breast and Stomach Cancers
The U.S. Food and Drug Administration (FDA) today approved trastuzumab-dkst (Ogivri) as a biosimilar to trastuzumab (Herceptin) for the treatment of patients with breast or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors overexpress the HER2 gene. The drug is the first...
FDA Announces Approval, CMS Proposes Coverage of First Breakthrough-Designated Test to Detect Extensive Number of Cancer Biomarkers
On November 30, the U.S. Food and Drug Administration (FDA) approved the FoundationOne CDx (F1CDx), the first breakthrough-designated, next-generation sequencing–based in vitro diagnostic test that can detect genetic mutations in 324 genes and 2 genomic signatures in any solid tumor type. The ...
NIH Partners With 11 Biopharmaceutical Companies on PACT Collaboration
On October 12, 2017, the National Institutes of Health (NIH) and 11 leading biopharmaceutical companies launched the Partnership for Accelerating Cancer Therapies (PACT), a 5-year public-private research collaboration totaling $215 million as part of the Cancer Moonshot. PACT will initially focus...
Pembrolizumab in Advanced Gastric Cancer
On September 22, 2017, pembrolizumab (Keytruda) was granted accelerated approval for treatment of recurrent locally advanced or metastatic, gastric or gastroesophageal junction adenocarcinoma with tumors expressing programmed cell death ligand 1 (PD-L1), as determined by a U.S. Food and Drug...
Clinical Trials Actively Recruiting Geriatric Oncology Patients
THE INFORMATION contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on geriatric oncology. These studies highlight psychological interventions, managing cancer symptoms, the surgical process, fall prevention, and making treatment decisions; as well ...
West Cancer Center Joins CancerLinQ® as Participating Practice
CANCERLINQ LLC, a wholly owned nonprofit subsidiary of ASCO, has announced that West Cancer Center in Tennessee has signed an agreement to participate in the CancerLinQ® platform. “The CancerLinQ® rapid learning system continues to be enriched through the participation of remarkable cancer care...
Copanlisib in Relapsed Follicular Lymphoma
On September 14, 2017, copanlisib (Aliqopa) was granted accelerated approval for treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies.1,2 Supporting Efficacy Data Approval was based on durable responses observed in a multicenter phase ...
Axicabtagene Ciloleucel for Large B-Cell Lymphoma
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On October 18, 2017, the chimeric antigen receptor (CAR)...
FDA Expands Approval of Sunitinib Malate for Adjuvant Treatment of Renal Cell Carcinoma After Nephrectomy
Today, the U.S. Food and Drug Administration (FDA) approved sunitinib malate (Sutent) for the adjuvant treatment of adult patients who are at a high risk of recurrent renal cell carcinoma after nephrectomy. “This is the first adjuvant treatment approved for patients with renal cell...
Immunotherapy in PD-L1–Positive Advanced Cervical Cancer
Pembrolizumab (Keytruda) treatment was active in patients with programmed cell death ligand 1 (PD-L1)–positive advanced cervical cancer enrolled in the phase Ib KEYNOTE-028 trial. The findings were reported by Frenel et al in the Journal of Clinical Oncology. Study Details In the advanced...
Internal Radiotherapy vs Kinase Inhibitor in Advanced Hepatocellular Carcinoma
A French phase III trial has shown no significant survival difference between selective internal radiotherapy with yttrium-90 resin microspheres vs sorafenib (Nexavar) in patients with advanced hepatocellular carcinoma. The findings were reported by Vilgrain et al in The Lancet Oncology. Study...
Gerold Bepler, MD, PhD, Elected to Association of American Cancer Institute’s Board of Directors
GEROLD BEPLER, MD, PhD, President and Chief Executive Officer of the Barbara Ann Karmanos Cancer Institute, has been elected to serve a 3-year term on the Association of American Cancer Institutes (AACI) Board of Directors. AACI comprises 97 leading cancer research centers in North America and is...
Conqueror in Action: Six-Time Survivor Brittany Sullivan Takes on Sarcoma
Alveolar soft part sarcoma (ASPS) is a cancer so rare that some oncologists have never heard of it. Brittany Sullivan, a 29-year-old anatomy teacher from Nashville, Tennessee, learned about it when she was 3 years old. She has been conquering it ever since. Since her childhood diagnosis, Ms....
AACR-NCI-EORTC: Colorectal Cancer Test Could Detect Early Cancer-Causing Genetic Biomarkers With High Degree of Sensitivity
An investigational test that screens for colorectal cancer could detect genetic mutations that are indicative of the disease with a high degree of sensitivity and specificity, according to results of a study presented by Powell et al at the AACR-NCI-EORTC International Conference on Molecular...
BE PREPARED TO ENCOURAGE HPV VACCINATION
“Human papillomavirus (HPV) vaccination coverage lags behind coverage for the other vaccines recommended for preteens,” according to the Centers for Disease Control and Prevention (CDC).1 A recent report about vaccination coverage in the United States among adolescents aged 13 to 17 found that...
FDA Awards Grants for Clinical Trials to Stimulate Product Development for Rare Diseases
THE U.S. FOOD and Drug Administration (FDA) has awarded numerous new clinical trial research grants, totaling more than $22 million over the next 4 years, to boost the development of products for patients with rare diseases. These new grants were awarded to principal investigators from academia and ...
Carfilzomib Improves Overall Survival vs Bortezomib in Relapsed/Refractory Multiple Myeloma
AT A PRESPECIFIED interim analysis, the phase III ENDEAVOR trial has shown a significant overall survival benefit for carfilzomib (Kyprolis) vs bortezomib (Velcade) in patients with relapsed/refractory multiple myeloma, as reported by Meletios A. Dimopoulos, MD, of the National and Kapodistrian...
For HPV Vaccine to Have Optimal Impact, ‘Provider Hesitancy’ Must Be Overcome
Honoring National Cancer Institute researchers Douglas R. Lowy, MD, and John T. Schiller, PhD, with the Lasker-DeBakey Clinical Medical Research Award for advances in technology that enabled the development of human papillomavirus (HPV) vaccines to prevent cervical cancer and other tumors caused by ...
FDA Approves CAR T-Cell Therapy to Treat Adults With Certain Types of Large B-Cell Lymphoma
On October 18, the U.S. Food and Drug Administration (FDA) approved axicabtagene ciloleucel (Yescarta), a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment....
Stand Up To Cancer Catalyst Launches 10 Clinical Trial Projects
Stand Up To Cancer has awarded 10 Stand Up To Cancer Catalyst clinical trial projects in which researchers from more than 30 institutions collaborate across academic and corporate borders on clinical trials studying correlated translational research. The inaugural Stand Up To Cancer Catalyst...
FDA Clears 7T Magnetic Resonance Imaging Device
On October 12, the U.S. Food and Drug Administration (FDA) cleared the first 7-Tesla (7T) magnetic resonance imaging (MRI) device, more than doubling the static magnetic field strength available for use in the United States. The Magnetom Terra is the first 7T MRI system cleared for clinical use in...
Potential Biomarkers to Identify Patients at Risk for Neurotoxicity From CAR T-Cell Therapy
Although lymphodepletion chemotherapy followed by an infusion of CD19-targeted chimeric antigen receptor (CAR)-modified T cells has produced high response rates in phase I studies of patients with refractory CD19-positive B-cell acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia...
Brentuximab Vedotin Granted FDA Breakthrough Therapy Designation in Front-Line Advanced Hodgkin Lymphoma
On October 2, Seattle Genetics, Inc, announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to brentuximab vedotin (Adcetris) in combination with chemotherapy for the front-line treatment of patients with advanced classical Hodgkin lymphoma. The positive ...
Integrative Therapies in Palliative Care Project
Palliative care professionals are invited to participate in a unique project sponsored by the National Cancer Institute. Collinge and Associates, Inc, is seeking interdisciplinary professionals to help develop and evaluate a new online continuing education (CE/CME) course on the use of integrative...
FDA Accepts sNDA for Lenvatinib for the Treatment of Hepatocellular Carcinoma
On September 26, Eisai Inc announced the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for lenvatinib (Lenvima) for potential use in the first-line treatment of patients with hepatocellular carcinoma. “Patients with...
Avelumab in Locally Advanced or Metastatic Urothelial Carcinoma
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On May 9, 2017, avelumab (Bavencio) was granted...
Combination of Rituximab and Hyaluronidase Human for Subcutaneous Use in Lymphoma and Leukemia
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On June 22, 2017, the combination of rituximab (Rituxan)...
ACS Awards Grants to Reduce Colorectal Cancer Disparities in American Indian and Alaska Native Populations
The American Cancer Society (ACS) has awarded $100,000 in grants to five community health centers across the country to reduce colon cancer disparities in American Indian and Alaska Native populations through the Community Health Advocates implementing Nationwide Grants for Empowerment and Equity...
Fox Chase Cancer Center Announces New Faculty, Appointments
Under the direction of Martin J. Edelman, MD, Chair, Department of Hematology/Oncology, who joined Fox Chase Cancer Center earlier this year, the department has been reorganized into four sections: Hematologic Malignancies, Solid Tumor Oncology, General Hematology/Oncology, and Fox Chase at Temple...
Tisagenlecleucel for B-Cell Acute Lymphoblastic Leukemia
On August 30, 2017, tisagenlecleucel (Kymriah) was granted regular approval for the treatment of patients up to age 25 years with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.1,2 Tisagenlecleucel is the first chimeric antigen receptor (CAR)...
Inotuzumab Ozogamicin for Relapsed/Refractory B-Cell Precursor ALL
On August 17, 2017, inotuzumab ozogamicin (Besponsa) was approved for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).1,2 Supporting Efficacy Data APPROVAL WAS BASED on complete remission rates in the open-label phase III INO-VATE ALL...
Regorafenib in Hepatocellular Carcinoma Previously Treated With Sorafenib
On April 27, 2017, the indications for regorafenib (Stivarga) were expanded to include treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib (Nexavar).1,2 Supporting Efficacy Data The new approval was based on the finding of improved overall survival...
Final Efficacy Analysis of 9-Valent Human Papillomavirus Vaccine Trial
The final efficacy analysis of a trial of 9-valent human papillomavirus (HPV) vaccine has shown a high preventive effect against disease due to the additional HPV pathogenic strains covered compared with the quadrivalent vaccine at up to 6 years. These findings were reported by Huh et al in The...
FDA Approves Copanlisib for Adults With Relapsed Follicular Lymphoma
Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to copanlisib (Aliqopa) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior systemic therapies. “For patients with relapsed follicular lymphoma, the cancer often...
FDA Approves First Biosimilar for the Treatment of Cancer
The U.S. Food and Drug Administration today approved bevacizumab-awwb (Mvasi) as a biosimilar to bevacizumab (Avastin) for the treatment of multiple types of cancer. Bevacizumab-awwb is the first biosimilar approved in the U.S. for the treatment of cancer. “Bringing new biosimilars to...
Pembrolizumab in PD-L1–Positive Nasopharyngeal Carcinoma
As reported by Hsu et al in the Journal of Clinical Oncology, pembrolizumab (Keytruda) has shown activity in programmed cell death ligand 1 (PD-L1)–positive recurrent or metastatic nasopharyngeal carcinoma, in a cohort of the phase Ib KEYNOTE-028 trial. Study Details In the study, 27...
First-Line Cetuximab vs Bevacizumab Plus Chemotherapy in KRAS Wild-Type Colorectal Cancer
A phase III trial has shown no significant difference in overall survival with first-line cetuximab (Erbitux) vs bevacizumab (Avastin) plus chemotherapy in patients with advanced or metastatic KRAS wild-type colorectal cancer. These study findings were reported by Alan Venook, MD, of University of ...
