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Showing 5801 - 5850FDA Oncology Drug Approvals Granted Between June 2017 and May 16, 2018
Over the past year (June 2017–May 2018), the U.S. Food and Drug Administration (FDA) granted approval to a number of new oncology drug products, including several biosimilar products. Here we provide the labeling approved for these novel drugs and new indications. EPOETIN ALFA-EPBX (RETACRIT)...
Husband and Wife Leave a Giant Legacy in Oncology
The remarkable careers of Jimmie C. Holland, MD, and James F. Holland, MD, spanned collectively for more than a century, leaving an indelible footprint in oncology clinical care and research. Synonymous with cancer care itself, the Hollands were a living documentary of the rich and dramatic history ...
AUA 2018: Is Prostate Cancer Screening and Risk Stratification Moving Beyond the PSA Test?
New diagnostic tests for prostate cancer, as well as new information about the impact of the U.S. Preventive Services Task Force recommendations on prostate cancer screening, were presented at the 113th Annual Meeting of the American Urological Association (AUA). PSA Screening of African American...
AUA 2018: Use of MRI for Prostate Cancer Screening and Management
Use of magnetic resonance imaging (MRI) in the diagnosis of prostate cancer is increasing and brings added value to screening and surveillance, according to new studies presented this year during the 113th Annual Meeting of the American Urological Association (AUA). Four studies highlighting the...
AUA 2018: More Than 40% of Prostate Biopsies May Have Been Avoided With Use of Assay for Detection
A multicenter study that validated the clinical performance of IsoPSA—a new blood test that has proven to be more accurate in predicting overall risk of prostate cancer than standard prostate-specific antigen (PSA)—was presented at the 13th Annual Meeting of the American Urological...
Hormonal Contraception and Breast Cancer Risk
As reported in The New England Journal of Medicine by Lina S. Mørch, PhD, of the University of Copenhagen, and colleagues, a Danish study has shown that the risk of breast cancer is increased in hormonal contraception users vs nonusers, with the absolute increase in risk being small. The study...
FDA Identifies Efficacy Issue in Clinical Trials of Pembrolizumab or Atezolizumab as Monotherapy in Urothelial Cancer With Low Expression of PD-L1
On May 18, the U.S. Food and Drug Administration (FDA) alerted health-care professionals, oncology clinical investigators, and the public about decreased survival associated with the use of pembrolizumab (Keytruda) or atezolizumab (Tecentriq) as monotherapy in clinical trials to treat patients with ...
Treatment of Malignant Pleural Mesothelioma: ASCO Clinical Practice Guideline
As reported by Hedy L. Kindler, MD, of the University of Chicago, and colleagues in the Journal of Clinical Oncology, ASCO has released a clinical practice guideline on the treatment of malignant pleural mesothelioma.1 The guideline was based on a systematic literature search and expert panel...
Stand Up To Cancer Launches Research Team to Detect Precursor Conditions of Multiple Myeloma
Stand Up To Cancer (SU2C) announced a $10 million award to a Stand Up To Cancer Dream Team focused on revolutionizing the treatment of multiple myeloma through the early detection of precursor conditions. In the hope of developing therapies to prevent myeloma in high-risk populations, the project...
Logistics of CAR T-Cell Therapy in Real-World Practice
With the U.S. Food and Drug Administration (FDA) approvals of tisagenlecleucel (Kymriah)1 and axicabtagene ciloleucel (Yescarta),2 chimeric antigen receptor (CAR) T-cell therapy has moved into real-world practice, offering new potentially curative options for incurable hematologic malignancies. Its ...
For James Allison, PhD, Perseverance and Hard Science Are Paramount in Cancer Research
For this installment in the Living a Full Life series of articles, guest editor Jame Abraham, MD, interviewed immunology pioneer James Allison, PhD, Chair of the Department of Immunology, the Vivian L. Smith Distinguished Chair in Immunology, Director of the Parker Institute for Cancer Research,...
Supporting Patients During and After Cancer Treatment: Evidence-Informed Approach to Lifestyle and Behavior Change
The ASCO Post’s Integrative Oncology series is intended to facilitate the availability of evidence-based information on integrative and complementary therapies sometimes used by patients with cancer. In this installment, Lorenzo Cohen, PhD, and Alison Jefferies, BA, MEd, summarize research...
Molecular Minimal Residual Disease Detection Shows Further Promise in Acute Myeloid Leukemia
Extended next-generation sequencing genomic profiling in acute myeloid leukemia (AML) has revealed remarkable heterogeneity and molecular complexity of the disease and provided critical insights into the genetic mechanisms underpinning of preleukemic and leukemic pathogenesis.1,2 Despite...
PARP Inhibitor Shows Promise in Patients With BRCA-Mutated Pancreatic Cancer
A targeted therapy that has been effective in fighting ovarian cancer in women, including those with BRCA1 and BRCA2 mutations, may also help patients with aggressive pancreatic cancer who harbor these mutations and have few or no other treatment options. An international team of researchers was...
Targeted Sequencing Detection of Molecular Minimal Residual Disease and Prognosis in Acute Myeloid Leukemia
In a study reported in The New England Journal of Medicine, Mojca Jongen-Lavrencic, MD, PhD, of Erasmus MC Cancer Institute, and colleagues found that molecular minimal residual disease identified by next-generation sequencing during complete remission was associated with an increased risk of...
How a Recent Study Heats up the Debate Over Intraperitoneal Chemotherapy in Newly Diagnosed Advanced Ovarian Cancer
Based on pharmacokinetic and preclinical data, there appears to be a biologic advantage to the use of intraperitoneal chemotherapy in treating some malignancies confined to the abdomen. Since most ovarian, fallopian tube, and peritoneal cancers present and recur in the peritoneal cavity, this...
ASCO Honors Leaders in Cancer Care With 2018 Special Awards
ASCO AND ASCO’s Conquer Cancer Foundation recognized winners of ASCO’s 2018 Special Awards and Conquer Cancer’s Women Who Conquer Cancer Mentorship Awards during the 2018 ASCO Annual Meeting, June 1 to June 4, in Chicago. The recipients of these awards included researchers, patient advocates, and...
Four Reasons to Use Social Media at the ASCO Annual Meeting
Join the discussion: Use #ASCO18 on Twitter and Instagram to follow and participate in the Annual Meeting conversation in real time. During last year’s Annual Meeting, more than 17,000 health-care professionals, researchers, news outlets, patients, advocates, and other participants sent more than...
Role of MRI in Detection of Clinically Significant Prostate Cancer: ‘Practice-Affirming’ Results From The PRECISION Trial
Simultaneously presented at the 2018 European Association of Urology meeting and published in The New England Journal of Medicine, the PRECISION trial will go down as a landmark study for solidifying the role of magnetic resonance imaging (MRI) in prostate cancer diagnosis.1 This trial provides...
MRI-Targeted vs Standard Biopsy in Prostate Cancer Diagnosis: The PRECISION Trial
In the international PRECISION trial reported in The New England Journal of Medicine, Veeru Kasivisvanathan, MRCS, of University College London, and colleagues found that magnetic resonance imaging (MRI)-targeted biopsy resulted in a significantly higher rate of diagnosis of clinically significant ...
Brentuximab Vedotin in Previously Untreated Stage III or IV Classical Hodgkin Lymphoma
On March 20, 2018, brentuximab vedotin (Adcetris) was approved for the treatment of adult patients with previously untreated stage III or IV classical Hodgkin lymphoma in combination with chemotherapy.1,2 Supporting Efficacy Data Approval was based on the findings of the open-label phase III...
Tisagenlecleucel for Adults With Relapsed or Refractory 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 May 1, 2018, tisagenlecleucel (Kymriah), a...
Weighing the Cost and Value of CAR T-Cell Therapy
This past year’s approval by the U.S. Food and Drug Administration (FDA) of two chimeric antigen receptor (CAR) T-cell therapies heralded a new era in both effective cancer treatments and the most expensive cancer drugs ever. Tisagenlecleucel (Kymriah) was initially approved for the treatment of...
FDA Approves First Epoetin Alfa Biosimilar for the Treatment of Anemia
On May 15, 2018, the U.S. Food and Drug Administration (FDA) approved epoetin alfa-epbx (Retacrit) as a biosimilar to epoetin alfa (Epogen/-Procrit) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. The biosimilar is...
Both Patients and Clinicians Face Challenges in Recognizing and Reporting Immune-Related Adverse Events
The publication of ASCO’s toxicity management guidelines for immune checkpoint antibodies by Brahmer and colleagues,1 reviewed in this issue of The ASCO Post, has been long awaited, considering more than 15 distinct indications have been granted by the U.S. Food and Drug Administration (FDA). The ...
ASCO Clinical Practice Guideline on Managing Immune-Related Adverse Events: Next Big Step for Immune Checkpoint Inhibitors
The publication of the ASCO clinical practice guideline for the management of immune therapy–related adverse events—reviewed in this issue of The ASCO Post—represents an important next step in the incorporation of checkpoint blocking antibodies as standard cancer treatment modalities.1 The U.S....
ASCO Clinical Practice Guideline: Management of Immune-Related Adverse Events From Immune Checkpoint Inhibitor Therapy
As reported in the Journal of Clinical Oncology by Julie R. Brahmer, MD, of Johns Hopkins Kimmel Cancer Center, and colleagues, ASCO has released a clinical practice guideline on management of immune-related adverse events in patients receiving immune checkpoint inhibitor therapy.1 Immune...
Here’s How ASCO Is Joining With Other Organizations to Reduce Obesity and Cancer Rates
GUEST EDITOR Prevention in Oncology is guest edited by Jennifer A. Ligibel, MD, Chair of ASCO’s Energy Balance Working Group and a member of ASCO’s Cancer Survivorship and Cancer Prevention Committees. Dr. Ligibel is Director of the Leonard P. Zakim Center for Integrative Therapies at Dana-Farber...
The Pharmacist’s Role in Educating the Health-Care Team About Adverse Effects of Immune Checkpoint Inhibitors
Named by ASCO as Advance of the Year for both 2016 and 2017,1 and with more than 10 U.S. Food and Drug Administration–approved indications—and more on the way—it’s safe to say the era of cancer immunotherapy is upon us. To prepare, physicians must understand not only which patients will benefit,...
Curbing Financial Toxicity: What Might Work, and What Won’t Work
To stem the rising tide of financial toxicity in cancer care, creative physician reimbursement strategies, by themselves, will not work, according to a thought leader in the field who advocated for elimination of the federal mandate against price negotiation, curbing the power of monopolies, and...
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): 2018 Guidelines Updates
In 1996, the National Comprehensive Cancer Network® (NCCN®) published its first set of Clinical Practice Guidelines in Oncology (NCCN Guidelines®) covering 8 tumor types. Guidelines are now published for more than 60 tumor types and topics. Some of the key updates were presented at NCCN’s 23rd...
FDA Expands Tisagenlecleucel Approval to Include Relapsed or Refractory Large B-Cell Lymphoma
On May 1, 2018, the U.S. Food and Drug Administration (FDA) approved tisagenlecleucel (Kymriah) for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade...
Expert Point of View: Howard Weinstein, MD
“These are excellent results, both overall and for patients randomly assigned to nelarabine with either high-dose methotrexate or escalated-dose methotrexate,” said Howard Weinstein, MD, Chief of Pediatric Hematology/Oncology at Massachusetts General Hospital, Boston, who was not involved in this...
Upfront Use of Nelarabine Plus Chemotherapy Improves Disease-Free Survival in T-Cell Malignancies
Upfront use of nelarabine plus standard Children’s Oncology Group–augmented Berlin-Frankfurt-Münster (aBFM) chemotherapy boosted survival rates in children and young adults with newly diagnosed T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic leukemia (T-LL), according to the...
Oxybutynin for Androgen Deprivation–Associated Hot Flashes in Prostate Cancer
In a letter to the editor of The New England Journal of Medicine, Smith et al describe successful use of oxybutynin to treat hot flashes in a patient receiving androgen-deprivation therapy (ADT) for prostate cancer. As noted by the authors, nonhormonal treatments for menopausal hot flashes in women ...
ASCO and ABIM Announce Collaboration on Maintenance of Certification Pathway
ASCO and the American Board of Internal Medicine (ABIM) have announced that they are working to co-create a pathway to provide doctors with a flexible way to maintain board certification. Beginning in 2020, oncologists will be able to choose from two different assessment pathways. They may take an ...
FDA Approves First Epoetin Alfa Biosimilar for the Treatment of Anemia
On May 15, the U.S. Food and Drug Administration (FDA) approved epoetin alfa-epbx (Retacrit) as a biosimilar to epoetin alfa (Epogen/Procrit) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. Epoetin alfa-epbx is also...
2018 ASCO: Mobile and Sensor Technology May Lead to Reduced Symptom Severity in Patients With Head and Neck Cancer
A randomized clinical trial evaluating the use of mobile and sensor technology to remotely monitor symptoms in patients receiving radiation therapy for head and neck cancer found that use of this technology reduced severe symptoms related to cancer and its treatment compared with usual care....
Researchers Identify Most Accurate Risk-Prediction Models for Lung Cancer Screening in Ever-Smokers
Recent lung cancer screening guidelines from the National Comprehensive Cancer Network(®) permit the use of risk models to refer ever-smokers for screening. However, different models select different screening populations and the performance of each model in selecting ever-smokers is...
Hormone Replacement Therapy and Breast Cancer Risk After Oophorectomy in BRCA1-Mutation Carriers
In a study reported in JAMA Oncology, Kotsopoulos et al found that use of hormone replacement therapy overall did not increase risk of breast cancer among BRCA1-mutation carriers after prophylactic bilateral salpingo-oophorectomy; however, use of estrogen-progesterone hormone replacement...
National Survey Examines Oncologists' Practices, Beliefs on Medical Marijuana Use
Data from a new survey show that as many as 80% of oncologists have discussed medical marijuana use with their patients. According to the authors, this is the first nationally representative survey to examine oncologists’ practices and beliefs on the subject since the implementation of state...
Thriving at Your First ASCO Annual Meeting
The ASCO Annual Meeting is the world’s largest multidisciplinary oncology conference, attracting over 30,000 attendees each year. Countless advances are unveiled in Chicago year after year. The sense of excitement generated by knowing that clinical practice may change for the bettering of our...
ASCO Hosts Inaugural State of Cancer Care in America Event to Examine Issues in Precision Medicine
Precision medicine is changing cancer care in profound ways. It is expected that the number of patients who benefit from precision medicine will continue to increase in the coming years, as treatments become more effective and research yields more insights on patient populations who are most likely ...
New Laws Reduce Costs of Oral Cancer Drugs, but Not for All
The rising cost of anticancer drugs not only adds fiscal pressure to our overburdened health-care system, but also increases the stress on patients with cancer and their families. High out-of-pocket spending may cause significant financial toxicity, even for patients with good health insurance...
Afatinib in Previously Untreated Metastatic NSCLC With Nonresistant EGFR Mutations
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 January 12, 2018, afatinib (Gilotrif) was approved...
Now More Than Ever, the Oncology Pharmacist Can Play a Variety of Roles on the Health-Care Team
Susannah E. Koontz, PharmD, BCOP, FHOPA, is a consultant for clinical pharmacy services, research, and education in the areas of pediatric hematology/oncology, stem cell transplantation, and cellular therapy. She has held positions at the Children’s Cancer Hospital at The University of Texas MD...
Planning for Potential Adverse Effects of Oral Chemotherapy
THE USE OF oral chemotherapy drugs is becoming more and more prevalent—for many types and stages of cancer, during different treatment phases, and for varying lengths of time. So it’s vital that physicians, nurses, and advanced practitioners understand all the potential adverse events of these...
Sentinel Lymph Node Biopsy and Management of Regional Lymph Nodes in Melanoma: ASCO/SSO Clinical Practice Guideline Update
AS REPORTED IN the Journal of Clinical Oncology by Sandra L. Wong, MD, of Dartmouth-Hitchcock Medical Center, and colleagues, ASCO and the Society of Surgical Oncology (SSO) have issued an update to the ASCO/SSO clinical practice guideline on sentinel lymph node biopsy and management of regional...
Obesity in Cancer Survivors: Identifying Teachable Moments
OBESITY IS associated with poor survival in patients with cancer, but when research is translated into survivorship care, obese and overweight patients can experience better outcomes, according to Karen Basen-Engquist, PhD, MPH, Professor of Behavioral Science and Director of the Center for Energy...
NCCN Debuts Three New Sets of Guidelines
THE NATIONAL Comprehensive Cancer Network® (NCCN®) debuted three sets of completely new guidelines for treating patients with uveal melanoma, for treating patients who have cancer and the human immunodeficiency virus (HIV), and for managing immune-related toxicities. Cancer in People Living With...
