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Showing 12801 - 12850Blinatumomab Granted Full Approval to Treat Relapsed or Refractory B-cell Precursor ALL in Adults and Children
On July 11, the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for blinatumomab (Blincyto) to include overall survival data from the phase III TOWER study. The approval converts blinatumomab's accelerated approval to a full approval. The sBLA...
FDA Approves First Companion Diagnostic Test to Simultaneously Screen for Multiple NSCLC Therapies
On June 22, the U.S. Food and Drug Administration (FDA) granted premarket approval to Thermo Fisher Scientific for the first next-generation sequencing–based test that simultaneously screens tumor samples for biomarkers associated with three FDA-approved therapies for non–small cell...
Priority Review Granted for Abemaciclib in the Treatment of Advanced Breast Cancer
On July 10, the U.S. Food and Drug Administration (FDA) accepted a new drug application (NDA) for abemaciclib, a cyclin-dependent kinase (CDK) 4/6 inhibitor, and gave the NDA a Priority Review designation. The NDA includes Eli Lilly and Company’s submission of abemaciclib for two indications: ...
FDA 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 ...
Cancer Research Grant Opportunities for Early-Career and Junior Faculty Researchers
The Conquer Cancer Foundation of ASCO is currently accepting applications for the 2018 Young Investigator Award (YIA) and Career Development Award (CDA). Young Investigator Award (YIA) A 1-year grant totaling $50,000, the YIA provides research funding to promising physicians to support the...
Conquer Cancer Foundation Researcher Spotlight: Dr. Supriya Mohile
SUPRIYA MOHILE, MD, MS Associate Professor of Medicine, Director of the Geriatric Oncology Clinic University of Rochester Medical Center Rochester, New York Older adults are the population most affected by cancer: 60% of all cancer occurs in this group. Yet the field of oncology that focuses on...
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....
Stay Up to Date on New Patient Materials From Cancer.Net
Encourage your patients to use social media to stay up to date with new resources available on Cancer.Net. It is easier than ever for patients to get the latest cancer information on their computer or mobile device by reading the Cancer.Net blog (www.cancer.net/blog) or following Cancer.Net on...
ASCO’s New MACRA Decision Tree Tool Helps Determine Which QPP Reporting Requirements Apply to Your Practice
Believe it or not, we’re halfway through the 1st year of the Quality Payment Program (QPP). ASCO, the Centers for Medicare & Medicaid Services (CMS), and other stakeholders have released guidance on successfully complying with QPP, but tailored information addressing a practice’s specific...
ASCO’s TAPUR Study Continues Its Expansion of Sites, Participants, and Collaborators
ASCO’s Targeted Agent and Profiling Utilization Registry (TAPUR) Study continues to expand and now has more than 300 participants enrolled on study drugs, more than 100 sites in 20 states, new partnerships, and a -revised protocol to lower the age of eligibility. Recently, eight new centers in 36...
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 ...
Expert Point of View: Leisha A. Emens, MD, PhD
STUDY DISCUSSANT Leisha A. Emens, MD, PhD, of Bloomberg~Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University, Baltimore, entitled her remarks, “Target Practice in Triple-Negative Breast Cancer,” referring to the fact that there is currently no validated target in this aggressive...
Potent PARP Inhibitor Moves Ahead in BRCA-Mutated Breast Cancer
TALAZOPARIB, a novel inhibitor of poly (ADP-ribose) polymerase (PARP), showed encouraging efficacy in breast cancer patients with BRCA1/2 mutations in the phase II ABRAZO trial, presented at the 2017 ASCO Annual Meeting by Nicholas C. Turner, MD, of the Royal Marsden Hospital and The Institute of...
Retreatment With Checkpoint Inhibitors May Be Feasible for Some Patients With NSCLC
INCREASING NUMBERS of patients are being treated with checkpoint inhibitors, and about one-quarter to one-third will develop immune-related adverse events. One question on the minds of oncologists is can these patients be safely re-treated once their adverse events resolve? One of the first...
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 ...
Expert Point of View: John Heymach, MD
"TO PUT THESE RESULTS into context, currently we have three approved epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors for EGFR-positive non–small cell lung cancer (NSCLC): gefitinib (Iressa), erlotinib (Tarceva), and afatinib (Gilotrif). Not many studies have compared these drugs ...
Dacomitinib Outperforms Gefitinib in EGFR-Positive NSCLC
DACOMITINIB, a second-generation epidermal growth factor receptor (EGFR)-targeted tyrosine kinase inhibitor, outperformed gefitinib (Iressa) as first-line treatment for EGFR-positive advanced non–small cell lung cancer (NSCLC) in the phase III ARCHER 1050 study.1 Dacomitinib improved...
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....
Expert Point of View: Hans Hammers, MD, PhD
THE COMBINATION of checkpoint inhibitors and vascular endothelial growth factor (VEGF) inhibitors is attractive in renal cell carcinoma, said formal discussant of this trial, Hans Hammers, MD, PhD, of the University of Texas Southwestern Medical Center in Dallas. “Twenty-one percent of patients...
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...
Expert Point of View: Nitin Jain, MD, and Susan O'Brien, MD
Formal discussant of the GENUINE trial, Nitin Jain, MD, of The University of Texas MD Anderson Cancer Center, Houston, noted that the majority of responses to ibrutinib (Imbruvica) in high-risk patients are partial responses. “These patients [have disease progression] even in the context of...
Ublituximab/Ibrutinib Beneficial in Patients With Chronic Lymphocytic Leukemia
The addition of ublituximab (a glycoengineered anti-CD20 antibody) to ibrutinib (Imbruvica) improved response rates, depth of response, and led to quicker resolution of ibrutinib-associated lymphocytosis in patients with high-risk chronic lymphocytic leukemia (CLL) in the phase III GENUINE trial,...
Expert Point of View: Michael S. Sabel, MD; Marcela Maus, MD, PhD; and Carl June, MD
"We are now seeing the merger of immunotherapy with precision medicine. This is the epitome of personalized medicine,” said ASCO-invited expert Michael S. Sabel, MD, Chief of the Division of Surgical Oncology at University of Michigan Health Systems, Ann Arbor. He called the effort to target...
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...
Expert Point of View: Leisha A. Emens, MD, PhD
Leisha A. Emens, MD, PhD, of the Bloomberg~Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University, commented on the promise of anti–programmed cell death protein 1/programmed cell death ligand 1 (PD-1/PD-L1) agents in triple-negative breast cancer. She noted that “an emerging theme...
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...
