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Showing 10701 - 10750FDA Accepts sNDA for Dasatinib in Pediatric Patients With Philadelphia Chromosome–Positive Chronic-Phase CML
On July 10, the U.S. Food and Drug Administration (FDA) accepted a supplemental new drug application (sNDA) to include an indication for dasatinib (Sprycel) to treat children with Philadelphia chromosome–positive chronic-phase chronic myeloid leukemia (CML), as well as a powder for oral...
MammaPrint Test Addressed in ASCO Breast Cancer Guideline Update
New recommendations on the use of the MammaPrint genomic test issued on July 10 will help guide decisions on adjuvant systemic therapy for women with early breast cancer. The recommendations update the ASCO 2016 clinical practice guideline on the use of biomarkers in these patients. The...
Narrow Network Insurance Plans More Likely to Exclude Doctors at NCI-Designated and NCCN Member Cancer Centers
Patients with cancer in the United States may be unable to access care at the nation’s top hospitals due to narrow insurance plan coverage—leaving patients to choose between lower premiums or access to higher-quality cancer care. A new study from the Perelman School of Medicine at the...
Delaying Lymph Node Biopsy After Melanoma Diagnosis May Not Adversely Affect Survival Rates
Postponing lymph node biopsy more than 30 days after melanoma diagnosis does not adversely impact long-term clinical outcomes, according to findings published by Nelson et al in the Journal of the American College of Surgeons. Today, management of high-risk melanomas starts with surgical removal...
FDA Grants 510(k) Clearance to Halcyon IMRT Treatment System
Varian Medical Systems has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Halcyon system, a new device for cancer treatment. Halcyon simplifies and enhances image-guided volumetric-intensity modulated radiotherapy (IMRT). “We are proud that Halcyon has now...
FDA Places Clinical Hold on Three Studies Evaluating Pembrolizumab in Multiple Myeloma
On July 5, Merck announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on KEYNOTE-183, KEYNOTE-185, and KEYNOTE-023, three combination studies of pembrolizumab (Keytruda), an anti–programmed cell death protein 1 (PD-1) therapy, in multiple myeloma. This...
FDA Approves Aminolevulinic Acid Hydrochloride as an Optical Imaging Agent Indicated in Gliomas
ON JUNE 6, the U.S. Food and Drug Administration (FDA) approved aminolevulinic acid hydrochloride, known as ALA HCl (Gleolan), as an optical imaging agent indicated in patients with gliomas (suspected World Health Organization [WHO] grades III or IV) for preoperative imaging, as an adjunct for the...
Has a New Standard Really Been Established for the Adjuvant Treatment of Pancreatic Cancer?
THE PAST YEAR has undoubtedly been a disappointing one as far as clinical advances in pancreatic cancer go. No fewer than five high-profile randomized phase II or III trials in this setting reported negative results in 2016, ranging from next-generation cytotoxic agents1 to novel immunotherapeutic ...
Encouraging Results With Pembrolizumab in Relapsed/Refractory Classical Hodgkin Lymphoma
AN EFFECTIVE antitumor immune response relies on cytotoxic T cells that are activated and able to target the malignant clone. As T cells become activated, they upregulate suppressive receptors including programmed cell death protein 1 (PD-1). Upregulation of inhibitory signals is important to...
A Great IDEA: Celebrating 15 Years of the International Development and Education Award
In 2017, ASCO and the Conquer Cancer Foundation of ASCO are proud to celebrate the 15th anniversary of the International Development and Education Award (IDEA). The IDEA program supports the professional development of early-career oncologists in low- and middle-income countries around the world....
Second Cancers May Be Deadlier in Child, Adolescent, and Young Adult Patients
Second cancers in children and adolescents and young adults (AYAs) are far deadlier than they are in older adults and may partially account for the relatively poor outcomes of cancer patients between the ages of 15 and 39 overall, a new study by researchers at the University of California, Davis...
Neoadjuvant Studies of Endocrine Approaches in Breast Cancer Mandated Before Embarking on Large Adjuvant Studies
Largely based on studies demonstrating that letrozole can suppress plasma estradiol levels to a greater extent than anastrozole,1 the adjuvant activity of these endocrine agents were compared in 4,136 patients with node-positive breast cancer in the FACE trial. As reviewed in this issue of The ASCO ...
James Francis McCarthy
The family and staff of Harborside Press mourn the loss of former colleague, and forever friend James F. McCarthy, who passed away after a brief illness on June 23, 2017. Born in Brooklyn, New York, on January 7, 1929, to John A. and Eda K. McCarthy, Jim was a graduate of Brooklyn Preparatory High ...
Missak Haigentz, MD, Joins Atlantic Health System Cancer Care
Head and neck and lung cancer researcher Missak Haigentz, MD, has joined Atlantic Health System Cancer Care as Chief of Hematology and Oncology at Morristown Medical Center and Medical Director of Atlantic Hematology and Oncology for Atlantic Medical Group at the Carol G. Simon Cancer Center. Dr....
Cancer Survivor Publishes Book for Children About Cancer
A book aimed at helping young families understand cancer, Hair to the Queen! is now available on Amazon. Written by first-time author Tamara B. Rodriguez and illustrated by Carole A. Smith, the book empowers adults to discuss cancer with children in a simple and compassionate way. Hair to the...
Big Data and the Learning Machine
BOOKMARK Title: The Master Algorithm: How the Quest for the Ultimate Learning Machine Will Remake Our WorldAuthor: Pedro DomingosPublisher: Beacon PressPublication date: February 2017Price: $24.95, hardcover, 288 pages Technology is revolutionizing our understanding and treatment of diseases....
Atezolizumab/Bevacizumab Moves Forward in Metastatic Renal Cell Carcinoma
THE COMBINATION of atezolizumab (Tecentriq) plus bevacizumab (Avastin) showed promising results as first-line treatment of patients with metastatic renal cell carcinoma, according to a phase II trial called IMmotion 150. Based on these results, the phase III IMmotion 151 trial is comparing...
Fat Grafting and Patient-Reported Outcomes in Postmastectomy Breast Reconstruction
The use of fat grafting as a tool for breast reconstruction following a mastectomy may improve breast satisfaction, psychosocial well-being, and sexual well-being in patients, according to a study published by Bennett et al in JAMA Surgery. Fat grafting as an adjunct to breast reconstruction...
FDA Grants Marketing Approval to the Praxis Extended RAS Panel
On June 29, the U.S. Food and Drug Administration (FDA) granted marketing approval to the Praxis Extended RAS Panel, a next-generation sequencing test to detect certain genetic mutations in RAS genes in tumor samples of patients with metastatic colorectal cancer. The test is used to aid in the...
Annual Report to the Nation: Cancer Death Rates Continue to Decline
Overall cancer death rates continue to decrease in men, women, and children for all major racial and ethnic groups, according to the latest Annual Report to the Nation on the Status of Cancer, 1975–2014, published by Jemal et al in the Journal of the National Cancer Institute.1 The report finds...
Pediatric Cancer Pain May Be Misunderstood and Largely Undertreated
Cancer pain in children poses certain unique challenges. Over the past decade, insightful research into pediatric cancer pain has focused on pain management that incorporates nonopioid therapies into standard care. To shed light on this important issue, The ASCO Post spoke with Christine T....
CAR T-Cell Therapy in Multiple Myeloma Yields 100% Response Rate
Chinese investigators reported that 100% of patients with relapsed or refractory multiple myeloma responded to autologous chimeric antigen receptor (CAR) T-cell therapy, and 14 of 19 (74%) who were followed for a median of 4 months achieved a stringent complete response and have not recurred.1...
New Supportive Care Resources From NCCN Help Patients With Cancer Confront Distress
All patients with cancer experience some level of distress associated with their cancer diagnosis and the effects of the disease and its treatment—regardless of the stage of disease. Not only does distress affect a patient’s mental and psychosocial well-being, but because distress is a risk...
Overcoming Sexism in Academic Medicine
The troubling results from a survey1 investigating the sexual harassment and discrimination experiences of academic medical faculty show that such incidents continue to happen with unexpected frequency despite increasing awareness of the problem. The study by Reshma Jagsi, MD, DPhil, and...
High-Risk Mutations Predict Poor Outcomes for Patients With Myelodysplastic Syndromes Undergoing Transplantation
Although several treatment options are available for patients with myelodysplastic syndromes (MDS), hematopoietic stem cell transplantation (HSCT) remains the only curative therapy.1 The risks of complications and death from transplantation can be substantial. Determining which patients may...
Pembrolizumab Moving Forward in Triple-Negative Breast Cancer
In the treatment of triple-negative breast cancer, checkpoint inhibition is making inroads in both early- and late-stage disease, and the line of treatment and expression of the programmed cell death ligand 1 (PD-L1) could be important in determining outcomes, according to studies reported at the...
Angela Alistar, MD, Joins Atlantic Health System Cancer Care
Gastrointestinal cancer researcher Angela Alistar, MD, has joined Atlantic Health System Cancer Care as Medical Director of GI Medical Oncology at Morristown Medical Center. Dr. Alistar is a board-certified medical oncologist who specializes in translational research. She comes to Atlantic Health...
World Health Assembly’s New Cancer Resolution Reflects New Realities
The World Health Assembly (WHA)—the decision-making body of the World Health Organization (WHO)—adopted a long-expected cancer resolution at its 2017 meeting, the body’s first resolution on cancer in 12 years and the first to emphasize, among other issues, the accessibility and affordability of...
First Comprehensive Pediatric Hematology/Oncology Initiative Launched in Africa
Through public-private partnerships with the governments of Botswana, Uganda, and Malawi, His Excellency the President Lieutenant General Dr. Seretse Khama Ian Khama, of the Republic of Botswana; the Honorable Minister Dorcas Makgato, of the Ministry of Health and Wellness; the Bristol-Myers Squibb ...
FDA Approves Panitumumab for Use in Wild-Type RAS Metastatic Colorectal Cancer
On June 30, 2017, the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for panitumumab (Vectibix) for patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic...
FDA Approves Daratumumab in Combination With Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has approved the use of the monoclonal antibody daratumumab -(Darzalex) in combination with pomalidomide (Pomalyst) and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide ...
Scalp Cooling to Prevent Chemotherapy-Induced Alopecia: Is It Now Ready for Prime Time?
In oncology, sometimes we forget about the small, everyday things that can significantly impact a patient’s life. When patients are explained the side effects of chemotherapy and chemotherapy-induced alopecia, most women will cry or become visibly upset. When a woman loses her hair, it represents...
Two Studies Show Scalp Cooling Reduces Hair Loss in Women Receiving Chemotherapy for Breast Cancer
An interim analysis of the SCALP trial, reported in JAMA by Julie Nangia, MD, of Baylor College of Medicine, and colleagues, showed that use of a scalp-cooling device significantly reduced hair loss in women receiving chemotherapy for stage I or II breast cancer compared with no scalp cooling.1 The ...
WCHN Launches Trial to Screen Newly Diagnosed Patients With Diabetes for Early-Stage Pancreatic Cancer
Western Connecticut Health Network (WCHN) has announced the launch of a 3-year research study that will investigate the link between new-onset diabetes and pancreatic cancer. The main goal of the study is to detect the often lethal cancer at a curable stage. The study was developed by a team of...
Understanding the Cultural Differences Among Ethnic Minorities in Palliative and End-of-Life Care
GUEST EDITOR Addressing the evolving needs of cancer survivors at various stages of their illness and care, Palliative Care in Oncology is guest edited by Jamie H. Von Roenn, MD. Dr. Von Roenn is ASCO’s Vice President of Education, Science, and Professional Development. Because cultural origins...
Phase III CASCADE Trial of Vadastuximab Talirine in Front-Line AML Discontinued
On June 22, 2017, Seattle Genetics confirmed it discontinued the phase III CASCADE clinical trial of vadastuximab talirine (SGN-CD33A) in front-line older acute myeloid leukemia (AML) patients. Patient enrollment and treatment in all of its vadastuximab talirine clinical trials are suspended,...
Idelalisib in Resistant CLL: Benefit Shown, Questions Remain
As reported in The Lancet Oncology by Dr. Andrew Zelenetz and colleagues and reviewed in this issue of The ASCO Post, an international phase III trial in 416 patients with refractory or recurrent chronic lymphocytic leukemia (CLL) addressed the benefit of adding the first-in-class phosphoinositide...
NewYork-Presbyterian Establishes William Rhodes and Louise Tilzer-Rhodes Center for Glioblastoma
NewYork-Presbyterian has established the William Rhodes and Louise Tilzer-Rhodes Center for Glioblastoma. Launched with an initial $5 million gift from William Rhodes, the new state-of-the-art program conducts groundbreaking research and provides cutting-edge treatments for glioblastoma and other...
Gideon M. Blumenthal, MD, Appointed OHOP Acting Deputy Office Director
Richard Pazdur, MD, Director of the Oncology Center of Excellence and Office of Hematology and Oncology Products (OHOP) Acting Director, has announced the appointment of Gideon M. Blumenthal, MD, as Acting Deputy Office Director of the OHOP at the U.S. Food and Drug Administration (FDA). Dr....
ESMO World GI 2017: Right-Sided Colorectal Tumors: An Internal Radiation Advantage
For patients with colorectal cancer that has metastasized to the liver, having a primary tumor on the left side as opposed to the right side of the colon is known to be a significant advantage in terms of treatment response. But a new study, presented by van Hazel et al at the European Society for...
FDA Clears Expanded Use of Cooling Cap to Reduce Hair Loss During Chemotherapy
On July 3, the U.S. Food and Drug Administration (FDA) cleared the expanded use of a cooling cap, DigniCap Cooling System, to reduce hair loss during chemotherapy. This is the first cooling cap cleared by the agency for use in cancer patients with solid tumors. “We are pleased to expand the...
FDA Approves Panitumumab for Use in Wild-Type RAS Metastatic Colorectal Cancer
Today, the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for panitumumab (Vectibix) for patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic colorectal cancer...
ESMO World GI 2017: Study Explores Association of Mediterranean Diet Components With Advanced Colorectal Polyps
The benefits of a Mediterranean diet are well known when it comes to colorectal protection, but it’s hard to know specifically what elements of the diet are the healthiest. Now a new study, presented by Fliss Isakov et al at the ESMO 19th World Congress on Gastrointestinal Cancer, suggests...
FDA Allows Marketing of Test to Aid in the Detection of Certain Leukemias and Lymphomas
On June 29, the U.S. Food and Drug Administration (FDA) allowed marketing of ClearLLab Reagents (T1, T2, B1, B2, M), the first agency-authorized test for use with flow cytometry to aid in the detection of several leukemias and lymphomas, including chronic leukemia, acute leukemia, non-Hodgkin...
European Commission Expands Use of Ceritinib for First-Line Use in ALK-Positive Advanced NSCLC
On June 29, the European Commission approved expanding the use of ceritinib (Zykadia) to include the first-line treatment of patients with advanced non–small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)–positive. Approval follows a positive opinion granted...
ESMO World GI 2017: Pegilodecakin Plus FOLFOX in Advanced Pancreatic Cancer
Clinical data on an investigational immuno-oncology drug pegilodecakin (PEGylated human interleukin-10, also known as AM0010) was presented by Hecht et al at the ESMO 19th World Congress on Gastrointestinal Cancer in Barcelona, Spain (Abstract O-004). Pegilodecakin is being evaluated in an ongoing...
ESMO World GI 2017: Phase I Data on Anti–PD-1 Antibody BGB-A317 in Hepatocellular Carcinoma
Preliminary results from patients with advanced hepatocellular carcinoma enrolled in a phase I study of the investigational anti–programmed cell death protein 1 (PD-1) antibody BGB-A317 in advanced solid tumors were presented by Yen et al at the ESMO 19th World Congress on Gastrointestinal...
FDA Unveils Plan to Eliminate Orphan Designation Backlog
Today, the U.S. Food and Drug Administration (FDA) unveiled a strategic plan to eliminate the agency’s existing Orphan Drug designation request backlog and ensure continued timely response to all new requests for designation with firm deadlines. The agency’s Orphan Drug Modernization...
FDA Takes Steps to Increase Drug Competition to Improve Patient Access
On June 27, the U.S. Food and Drug Administration (FDA) took two new, important steps to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives. The agency published a list of off-patent, off-exclusivity branded drugs without approved generics, and ...
Underused Blood Test Could Improve Treatment for Large Swath of Patients With Colon Cancer
A simple blood test could improve treatment for more than one in six patients with stage II colon cancer, suggests new research from the Mayo Clinic. Researchers also discovered that many patients who could benefit from the test likely aren’t receiving it. These findings were published by...
