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Showing 9651 - 9700FDA 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...
ASCO Guideline on Stage IV NSCLC Therapy Updated
An update of the ASCO clinical practice guideline on the systemic treatment of patients with stage IV non–small cell lung cancer (NSCLC) clarifies the role of immunotherapy in this setting. The update was published by Hanna et al in the Journal of Clinical Oncology.1 “This guideline update...
IASLC 2017: IASLC Releases New Atlas of EGFR Testing
The International Association for the Study of Lung Cancer (IASLC) released its Atlas of EGFR Testing in Lung Cancer at the IASLC 18th World Conference on Lung Cancer (WCLC) in Yokohama, Japan. The EGFR Atlas provides health-care professionals with information on EGFR testing processes and...
IASLC 2017: Treatment Based on BRCA1 Level Does Not Increase Survival of Stage II/III NSCLC Node-Positive Resected Patients
New research shows that treating stage II and III non–small cell lung cancer (NSCLC) node-positive resected patients with customized chemotherapy based on their specific BRCA1 expression levels, as opposed to providing the standard treatment, did not increase overall survival rates among...
Norman E. Sharpless, MD, Sworn in as Director of the National Cancer Institute
Norman E. “Ned” Sharpless, MD, took the oath of office late Tuesday, October 17, 2017, to become the 15th Director of the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). He succeeds Harold E. Varmus, MD, who stepped down as Director in March 2015....
IASLC 2017: REVEL Trial Subgroup Analysis Further Clarifies Outcomes With Ramucirumab Plus Docetaxel in Advanced Non–Small Cell Lung Cancer
New subgroup analysis from the phase III REVEL trial of ramucirumab (Cyramza) in advanced non–small cell lung cancer (NSCLC) was presented at the International Association for the Study of Lung Cancer (IASLC) 18th World Conference on Lung Cancer in Yokohama, Japan. Specifically, these...
PI3K Inhibition in Relapsed or Refractory Indolent Lymphoma
As reported in the Journal of Clinical Oncology by Dreyling et al, the phase II CHRONOS-1 trial has shown a high response rate and durable responses with the phosphatidylinositol 3-kinase (PI3K) inhibitor copanlisib (Aliqopa) in adults with relapsed or refractory indolent lymphoma who had received...
Long-Term Use of Long-Acting Insulin Analogs and Breast Cancer Risk in Type 2 Diabetes
A study in the UK population has shown that long-term use of the long-acting insulin glargine was associated with increased risk of breast cancer among women with type 2 diabetes. The findings were reported by Wu et al in the Journal of Clinical Oncology. Study Details The study involved a...
Immunotherapy for Previously Treated Advanced Gastric Cancer
In an Asian phase III trial (ONO-4538-12, ATTRACTION-2) reported in The Lancet, Kang et al found that nivolumab (Opdivo) produced an improvement in overall survival vs placebo in patients with advanced gastric or gastroesophageal junction cancer who had disease refractory to or who were intolerant...
FDA Grants Priority Review for Cabozantinib in Previously Untreated Advanced Renal Cell Carcinoma
On October 16, the U.S. Food and Drug Administration (FDA) determined the supplemental New Drug Application (sNDA) for cabozantinib (Cabometyx) for patients with previously untreated advanced renal cell carcinoma (RCC) to be sufficiently complete to permit a substantive review. The FDA granted...
IASLC 2017: Race, Socioeconomic Factors Are Influential in NSCLC Survival Rates
New research found race and specific socioeconomic factors to have a significant influence on disparities in the survival rates of non–small cell lung cancer (NSCLC) patients. Yanyan Lou, MD, PhD, of the Mayo Clinic, presented these findings at the International Association for the Study of...
IASLC 2017: CheckMate-032: Nivolumab Alone or With Ipilimumab in Recurrent SCLC With High Tumor Mutation Burden
At the International Association for the Study of Lung Cancer (IASLC) 18th World Conference on Lung Cancer in Yokohama, Japan, Bristol-Myers Squibb announced data evaluating nivolumab (Opdivo) and nivolumab plus ipilimumab (Yervoy) in previously treated small cell lung cancer (SCLC) patients whose...
IASLC 2017: Early Palliative Care Provides No Quality-of-Life Benefits for Patients With Recently Diagnosed Malignant Pleural Mesothelioma
Early specialist palliative care for patients that were recently diagnosed with malignant pleural mesothelioma does not impact quality-of-life measures, according to research presented by Fraser Brims, MBcHB, MRCP, MD, FRACP, of Curtin University in Australia, at the International Association...
Maintenance Therapy After ASCT in Younger Patients With Mantle Cell Lymphoma
In a French phase III trial, maintenance rituximab (Rituxan) improved event-free survival vs observation after autologous stem cell transplantation (ASCT) in younger patints with mantle cell lymphoma. These findings were reported by Le Gouill et al in The New England Journal of Medicine. Study...
Amended Health Insurance Rule Threatens Key Component of Standard Cancer Treatment
On October 12, ASCO President Bruce E. Johnson, MD, FASCO, issued the following statement: The Trump administration's move to expand the rights of employers to opt out of the requirement for contraceptive coverage would have unexpected and deleterious consequences for patients of childbearing age...
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...
FDA Grants Priority Review for Abemaciclib as Initial Treatment of Advanced Breast Cancer
On October 12, Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) granted Priority Review designation to its New Drug Application (NDA) for abemaciclib (Verzenio), a cyclin-dependent kinase (CDK) 4/6 inhibitor. MONARCH 3 The NDA was based upon the positive interim...
sNDA Submitted for Rucaparib as Maintenace Treatment for Patients With Platinum-Sensitive Recurrent Ovarian Cancer
On October 9, Clovis Oncology announced that the company submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration for rucaparib (Rubraca) as maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer...
First-Line Immunotherapy for Cisplatin-Ineligible Patients With Advanced Urothelial Cancer
As reported in The Lancet Oncology by Balar et al, first-line pembrolizumab (Keytruda) produced durable responses in cisplatin-ineligible patients with locally advanced and unresectable or metastatic urothelial cancer in the phase II KEYNOTE-052 trial. The trial supported the accelerated approval...
Ranjana H. Advani, MD, on Hodgkin Lymphoma: New Management Options
Ranjana H. Advani, MD, of Stanford Cancer Institute, discusses the novel immunomodulatory agents used to manage patients with relapsed or refractory Hodgkin lymphoma.
David G. Maloney, MD, PhD, on ALL: New Therapeutic Agents
David G. Maloney, MD, PhD, of the Fred Hutchinson Cancer Research Center, reviews the clinical data and ongoing trials evaluating immunotherapy in the setting of relapsed or refractory acute lymphocytic leukemia and discusses major adverse events of treatment.
Osimertinib Granted Breakthrough Therapy Designation for First-Line Treatment of EGFR Mutation–Positive NSCLC
On October 9, AstraZeneca announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for osimertinib (Tagrisso) for the first-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation–positive non–small cell lung ...
Cancers Associated With Overweight and Obesity Make Up 40% of Cancers Diagnosed in the United States
Overweight and obesity are associated with increased risk of 13 types of cancer—and these cancers account for about 40% of all cancers diagnosed in the United States in 2014—according to the latest Vital Signs report by the Centers for Disease Control and Prevention (CDC). Overall, the...
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 ...
Treating Breast Cancer During Pregnancy Calls for Careful Timing of Therapies and Sensitive Discussions With Patients
Breast cancer during pregnancy is relatively uncommon; however, it poses a significant clinical challenge to the patient and her multidisciplinary care team. To shed light on this difficult issue, The ASCO Post spoke with Carey K. Anders, MD, a medical oncologist and researcher at the University...
Dana-Farber Opens New Facility for Integrative Therapies
DANA-FARBER CANCER INSTITUTE has announced the opening of the new Leonard P. Zakim Center for Integrative Therapies and Healthy Living. Increasing data have indicated that integrative therapies can help alleviate the side effects of cancer therapy. The Zakim Center, as it is commonly referred to,...
For Breast Cancer Specialist Ann H. Partridge, MD, MPH, Medicine Is a Family Tradition
Breast cancer specialist Ann H. Partridge, MD, MPH, was born in Manhasset, Long Island, and grew up several miles east in Muttontown, New York. Since tiny Muttontown didn’t have its own school system, Dr. Partridge went to high school in nearby Locust Valley, a town on Long Island’s North Shore,...
Nivolumab in MSI-H or dMMR Metastatic Colorectal Cancer
ON JULY 31, 2017, nivolumab (Opdivo) was granted accelerated approval for treatment of patients 12 years and older with DNA mismatch repair–deficient (dMMR) and microsatellite instability– high (MSI-H) metastatic colorectal cancer progressing following treatment with a fluoropyrimidine,...
Nivolumab in Advanced DNA Mismatch Repair–Deficient or Microsatellite Instability–High Colorectal Cancer
THE PHASE II CHECKMATE 142 TRIAL has shown that nivolumab (Opdivo) produces durable responses in previously treated recurrent or metastatic DNA mismatch repair–deficient (dMMR)/ microsatellite instability–high (MSI-H) colorectal cancer. These study findings were reported in The Lancet Oncology...
Overview of the Phase III MSLT-II Trial
THE PHASE III MSLT- II TRIAL showed that completion dissection was not associated with improved melanoma-specific overall survival vs observation in patients with sentinel-node metastasis, although a benefit was observed in regional disease control. The findings were reported in The New England...
Blood-Based Biomarker: Predicting Efficacy of Immunotherapy in Patients With Melanoma
IN WHAT APPEARS TO BE the largest blood-based biomarker study of a checkpoint inhibitor, an RNA transcript–based gene classifier was able to predict for melanoma patients’ response to tremelimumab. The study was recently published in the Journal for ImmunoTherapy of Cancer.1 “Our study, in many...
Expert Point of View: Sandro Pignata, MD
FORMAL DISCUSSANT of ARIEL3, Sandro Pignata, MD, of the IRCCS National Cancer Institute, “Fondazione G. Pascale,” Naples, Italy, said: “This is new evidence for maintenance therapy with rucaparib [Rubraca]. These results are extraordinary, particularly in the BRCA mutation patients, but also in...
Strong Showing for Rucaparib Maintenance Therapy for Platinum-Sensitive Ovarian Cancer
EVIDENCE CONTINUES to mount for the benefits of poly (ADP-ribose) polymerase (PARP) inhibition in ovarian cancer. Rucaparib (Rubraca) maintenance therapy after response to platinum-containing therapy significantly improved progression-free survival in patients with recurrent ovarian cancer compared ...
‘Clinically Meaningful’ Results With First-Line Osimertinib in EGFR–Positive NSCLC
OSIMERTINIB (TAGRISSO) showed encouraging results as first-line therapy for patients with epidermal growth factor receptor (EGFR)–mutated non–small-cell lung cancer (NSCLC) in the phase III FLAURA trial, according to results presented at the 2017 European Society for Medical Oncology (ESMO)...
‘Clinically Meaningful’ Results With First-Line Osimertinib in EGFR–Positive NSCLC
OSIMERTINIB (TAGRISSO) showed encouraging results as first-line therapy for patients with epidermal growth factor receptor (EGFR)–mutated non–small-cell lung cancer (NSCLC) in the phase III FLAURA trial, according to results presented at the 2017 European Society for Medical Oncology (ESMO)...
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...
Expert Point of View: Manuela Schmidinger, MD
FORMAL DISCUSSANT, Manuela Schmidinger, MD, of the Medical University of Austria, Vienna, commented on the CheckMate 214 findings. “We have just seen a change in the paradigm in the treatment of metastatic renal cell cancer.” “More than a decade ago, VEGF [vascular endothelial growth factor]...
Nivolumab Plus Ipilimumab vs Sunitinib Alone as First-Line Therapy for Metastatic Renal Cell Carcinoma
A CHANGE IN PARADIGM may be on the horizon for the treatment of metastatic renal cell carcinoma. According to the results of CheckMate 214, the combination of ipilimumab (Yervoy) plus nivolumab (Opdivo) outperformed the standard of care—sunitinib (Sutent)—for first-line treatment, with improved...
MSLT-II Completion Lymph Node Dissection Trial: Practice Changing but Not Likely Practice Abandoning
PROBABLY THE MOST IMPORTANT advance in the treatment of newly diagnosed primary melanoma has been the incorporation of sentinel lymph node biopsy as part of initial surgical management. The routine use of sentinel lymph node biopsy, often termed “sentinel lymphadenectomy,” in appropriately...
Can We Have a Successful Vaccine Against Cancer?
EARLY IN our careers, few of us imagined that a vaccine could one day prevent cancer. Now, there is a vaccine that keeps the risks from human papillomavirus (HPV) at bay, and yet universal adoption of the HPV vaccine has been incomplete. As a result of misinformation about the vaccine—and its...
Study Finds 'Standard Care' Treatments in Breast Cancer Clinical Trials Not Always Standard
Historically, randomized controlled trials have served as the state-of-the-art method for determining the efficacy and safety of new, innovative treatment regimens for patients with cancer and other diseases. It is imperative that such trials are carefully designed to ensure that they are...
European Commission Approves Obinutuzumab for Previously Untreated Advanced Follicular Lymphoma
On September 22, Roche announced that the European Commission has approved obinutuzumab (Gazyvaro in Europe; available in the United States as Gazyva) in combination with chemotherapy, followed by obinutuzumab maintenance in patients achieving a response, as a new treatment for previously untreated ...
Comparison of First-Line Treatments for EGFR-Mutant NSCLC
The phase III ARCHER 1050 trial has shown superior progression-free survival with the second-generation irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor dacomitinib vs gefitinib (Iressa) in the first-line treatment of advanced EGFR-mutant non–small cell lung...
FDA Conducts Global Operation to Protect Consumers From Potentially Dangerous Prescription Drugs Sold Online
The U.S. Food and Drug Administration (FDA), in partnership with international regulatory and law enforcement agencies, recently took action against more than 500 websites that illegally sell potentially dangerous, unapproved versions of prescription medicines, including opioids, antibiotics, and...
What Is the Most Important Factor Women Consider in Deciding on SERM Use to Reduce Their Risk of Breast Cancer?
Currently, two medications have been approved by the U.S. Food and Drug Administration to reduce the risk of breast cancer: tamoxifen and raloxifene. Both medications, selective estrogen receptor modulators (SERMs), have been shown to reduce the risk for breast cancer by up to 50% in prevention...
Biden Cancer Initiative: Accelerating Progress in Cancer Research
Earlier this year, at the Alexandria Center for Life Science, former Vice President Joe Biden and Jill Biden, PhD, launched the Biden Cancer Initiative, their new venture to continue the fight to make progress in cancer prevention, detection, treatment, and care. The Biden Cancer Initiative will...
ASTRO 2017: Shorter Course of Radiation Treatment Safe for Breast Cancer Patients Under 50
A higher-dose, shorter form of radiation is safe, effective, and no more damaging to the breast tissue or skin of breast cancer patients under age 50 than it is in older patients. This is the finding of a study led by researchers from Perlmutter Cancer Center at New York University (NYU)...
Molecular Profiling of Key Survival Proteins in B-Cell Lymphoma Subtypes
Investigators at the Sidney Kimmel Cancer Center at Jefferson uncovered potential new proteins that contribute to the development and progression of several types of lymphoma. Their findings were published by Adams et al in Clinical Cancer Research. The researchers focused their attention on...
