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FDA Approves Nivolumab for Certain Patients With Previously Treated Small Cell Lung Cancer

Today, nivolumab (Opdivo) received approval from the U.S. Food and Drug Administration (FDA) for patients with metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy. Approval for this indication has been...

breast cancer
gynecologic cancers
issues in oncology

BRCA Testing in Medically Underserved Women in Southeastern United States

Medically underserved women in the Southeast region of the United States diagnosed with breast cancer or ovarian cancer may have not received genetic testing that could have helped them and their relatives make important decisions about their health, according to new research from Vanderbilt-Ingram ...

FDA Accepts Biologics License Application, Grants Priority Review for Tagraxofusp in Rare Hematologic Malignancy

The U.S. Food and Drug Administration (FDA) has accepted for filing a biologics license application (BLA) for tagraxofusp (Elzonris, formerly SL-401) for the treatment of patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare hematologic malignancy. The FDA also granted Priority ...

FDA Approves Lenvatinib for Unresectable Hepatocellular Carcinoma

Today, the U.S. Food and Drug Administration (FDA) approved lenvatinib capsules (Lenvima) for first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). REFLECT Trial Approval was based on the international, multicenter, randomized, open-label, noninferiority REFLECT trial ...

lung cancer
issues in oncology

Small Study Looks at Physician-Patient Discussions About Lung Cancer Screening

National guidelines advise doctors to discuss the benefits and harms of lung cancer screening with high-risk patients. A small study (n = 14) by researchers from the University of North Carolina Lineberger Comprehensive Cancer Center reported there is a gap between what guidelines...

VB4-845 Granted Fast Track Designation by FDA for Treatment of Non–Muscle Invasive Bladder Cancer

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to VB4-845 for the treatment of bacillus Calmette-Guérin (BCG)–unresponsive, high-grade, non–muscle invasive bladder cancer. VB4-845 is currently being evaluated in a phase III registration...

Basal Cell Carcinoma and Risk for Development of Other Cancers

Patients who develop frequent cases of basal cell carcinoma appear to be at significantly increased risk for the development of other cancers, according to a study published by Cho et al in JCI Insight. Methods Researchers studied 61 people treated at Stanford Health Care for frequent...

Drug Combination Design for Multiple Myeloma Using an AI Platform

A multidisciplinary team of researchers from the National University of Singapore (NUS) has developed an artificial intelligence (AI) technology platform that could potentially change the way drug combinations are being designed, hence enabling doctors to determine the most effective drug...

FDA Grants Clearance of PowerLook Density Assessment for Digital Breast Tomosynthesis

iCAD has announced U.S. Food and Drug Administration (FDA) clearance of its artificial intelligence software program, PowerLook Density Assessment Version 3.4, which provides an automated method of determining breast density. The software is compatible with iCAD’s digital breast...

gynecologic cancers
pancreatic cancer

FDA Grants Breakthrough Device Designation for Cancer Detection Liquid Biopsy

PapGene, Inc, has announced their cancer detection test has received Breakthrough Device designation from the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA). The PapGene test is a multianalyte test that uses a combination of circulating tumor DNA...

breast cancer
issues in oncology

Cardiac Monitoring in Patients With Breast Cancer

Although heart failure is an uncommon complication of breast cancer treatment, the risk may be higher in patients treated with certain types of chemotherapy and lower in younger patients, according to a study published by Henry et al in JACC: Cardiovascular Imaging. Researchers studied 16,456...

FDA Grants Breakthrough Therapy Designation for Encorafenib Plus Binimetinib and Cetuximab in BRAF V600E–Mutant Metastatic Colorectal Cancer

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for encorafenib (Braftovi) in combination with binimetinib (Mektovi) and cetuximab (Erbitux) for the treatment of patients with BRAF V600E–mutant metastatic colorectal cancer (mCRC), as detected by...

Cory Wiegert Named New CEO of CancerLinQ LLC

Cory Wiegert has been named Chief Executive Officer (CEO) of CancerLinQ LLC, a wholly owned nonprofit subsidiary of ASCO. Mr. Wiegert, a proven expert in building and successfully launching innovative technology solutions, began his new role today (August 13, 2018), overseeing the continued...

ESR1 Fusions and Metastasis in Estrogen Receptor–Positive Breast Cancer

Estrogen receptor–positive breast cancer is the most common type of breast cancer, but resistance to therapy is common, and eventual development of metastatic disease is a leading cause of death. In research published by Lei et al in Cell Reports, researchers from Baylor College of...

Assay Uses Big Data to Predict Responses to Immunotherapy

In the age of big data, cancer researchers are discovering new ways to monitor the effectiveness of immunotherapy treatments. Researchers at the Johns Hopkins Bloomberg~Kimmel Institute for Cancer Immunotherapy developed a new way to use bioinformatics as a gathering tool to determine how ...

FDA Grants 510(k) Clearance to SRT-100+ Superficial Radiation Therapy for Treating Nonmelanoma Skin Cancer and Keloids

Sensus Healthcare, Inc, a medical device company specializing in the noninvasive treatment of nonmelanoma skin cancers and keloids with image-guided superficial radiation therapy, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its new...

Why Do You Live to Conquer Cancer? Join New ASCO Campaign to Share Your Story!

ASCO RECENTLY launched its new “I Live to Conquer Cancer” national outreach and awareness campaign to draw attention to the critical importance of federally funded cancer research. Through a series of compelling videos and written stories, “I Live to Conquer Cancer” puts a human face on cancer...

health-care policy

CMS Proposes Extended 340B Cuts for 2019

ON JULY 25, the Centers for Medicare & Medicaid Services (CMS) released its 2019 Hospital Outpatient Prospective Payment System proposed rule. Among other provisions, the proposal would extend 2018 reimbursement cuts to the 340B Drug Pricing Program to include currently excepted, off-site...

gynecologic cancers

FDA Approves HPV Test for First-Line Cervical Cancer Screening

ON JULY 30, 2018, Roche announced approval by the U.S. Food and Drug Administration (FDA) of its cobas HPV Test in first-line screening for cervical cancer in women 25 years and older using cervical specimens collected in SurePath preservative fluid. The FDA first approved the cobas HPV test...

palliative care

Meeting the Challenges of Immunotherapy-Related Toxicities

In 2011, the U.S. Food and Drug Administration (FDA) approved ipilimumab (Yervoy), an anticytotoxic T-lymphocyte– associated antigen 4 (CTLA-4), the first checkpoint inhibitor for the treatment of advanced melanoma.1 Since then, several more checkpoint inhibitors directed at both the programmed...

lung cancer

My Incidentally Discovered Cancer

In February 2015, there was no indication that my life was about to radically change. I was a practicing attorney and happily raising two young children with my husband. At 40 years old, I was healthy—or so I thought—and had no physical symptoms to alert me to the devastating news that was about to ...

issues in oncology

Ensuring Quality With Patient-Reported Outcomes and Electronic Health Records

Accurately assessing the quality of cancer care over the continuum of treatment requires a special set of metrics and data-gathering methods. Moreover, with a growing number of cancer survivors, the post-treatment care involves primary care providers who are adept at managing the comorbidities...

health-care policy
issues in oncology

ASCO Statement: Step Therapy Creates Barriers to Care for Medicare Advantage Beneficiaries With Cancer

Monica M. Bertagnolli, MD, FACS, FASCO, ASCO President, released the following statement today: “ASCO strongly opposes the Centers for Medicare & Medicaid Services (CMS) decision to allow Medicare Advantage plans to employ step therapy across physician-administered and self-administered...

genomics/genetics

Is Some DNA Worthless?

BOOKMARK Title: Junk DNA: A Journey Through the Dark Matter of the GenomeAuthor: Nessa CareyPublisher: Columbia University PressOriginal publication date: April 2015Price: $22.95, paperback, 360 pages When biologists first delved into the human wonder of genes in the 1970s, they eventually...

A Celebrity Gadfly’s Reflections on His Death and Other Things Meant to Irritate

BOOKMARK Title: MortalityAuthor: Christopher HitchensPublisher: Twelve: Hachette Book GroupOriginal Publication Date: May 13, 2014Price: $19.95, paperback, 128 pages “There are no atheists in foxholes” is an aphorism used to contend that in times of extreme fear, such as during war or facing a...

issues in oncology

The Story of a Notorious Cluster of Childhood Cancers

BOOKMARK Title: Toms River: A Story of Science and SalvationAuthor: Dan FaginPublisher: Random HouseOriginal publication date: March 2013Price: $28.00, hardcover, 560 pages The Toms River emerges in the Pine Barrens of northern Ocean County, New Jersey, and zigzags through wetlands, emptying into...

prostate cancer

NIH and Prostate Cancer Foundation Launch Large Study on Aggressive Prostate Cancer in African American Men

The largest coordinated research effort to study biologic and nonbiologic factors associated with aggressive prostate cancer in African American men has begun. The $26.5 million study is called RESPOND, or Research on Prostate Cancer in Men of African Ancestry: Defining the Roles of Genetics, Tumor ...

solid tumors

FDA Approves First Treatment for Rare Adrenal Tumors

On July 30, 2018, the U.S. Food and Drug Administration (FDA) approved iobenguane I 131 injection (Azedra) for intravenous use in the treatment of adults and adolescents aged 12 and older with unresectable pheochromocytoma or paraganglioma that have spread beyond the original tumor site and require ...

health-care policy

Is Universal Health Care a Human Right?

The Affordable Care Act (ACA) provided oncology services to people with cancer who had previously been denied coverage. And for that reason alone, many oncologists supported its passage. However, even though the U.S. health-care system remains in the crosshairs of partisan politics, parties on both ...

ASCO and Friends Submit Recommendations to FDA Aimed at Reducing Barriers to Clinical Trial Participation

ASCO and Friends of Cancer Research (Friends) have submitted recommended language to the U.S. Food and Drug Administration (FDA) for five guidance documents on ways to broaden eligibility criteria for cancer clinical trials. The recommendations are part of an ASCO...

leukemia
issues in oncology

Guidelines for Pediatric CAR T-Cell Therapy Developed

Almost 1 year after the U.S. Food and Drug Administration (FDA) approval of chimeric antigen receptor (CAR) T-cell therapy for children with acute lymphoblastic leukemia (ALL), researchers at The University of Texas MD Anderson Cancer Center and the Pediatric Acute Lung Injury and...

Utilization of Hypofractionated Radiation Therapy in Breast Cancer

Researchers at the Feinstein Institute for Medical Research and Northwell Health’s Department of Radiation Medicine have identified methods to increase use of the radiation therapy hypofractionation in patients with breast cancer. These findings, published by Gilbo et al...

lung cancer
issues in oncology

Lung Cancer Screening Guidelines May Be Inadequate for High-Risk Minorities

Data from a lung cancer screening program at the University of Illinois at Chicago (UIC) provides evidence that national lung cancer screening guidelines, which were developed based on the National Lung Screening Trial (NLST) in 2011 and recommend screening based on age and smoking history, may be...

Cedars-Sinai Affiliate Announces New Cancer Center to Open in 2019

The Torrance Memorial Medical Center, a Cedars-Sinai Medical Center affiliate, recently announced the opening of a new cancer center. The new Hunt Cancer Center will provide patients with access to subspecialists who treat more than 60 types of common, rare, and complex cancers. As part of the...

breast cancer

FDA Expands Ribociclib Indication in Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer

On July 18, 2018, the U.S. Food and Drug Administration (FDA) expanded the indication for ribociclib (Kisqali), in combination with an aromatase inhibitor for pre/perimenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based...

solid tumors

NCCN Announces New Patient Guideline in Liver, Gallbladder, and Bile Duct Cancers

The National Comprehensive Cancer Network® (NCCN®) has released a new resource to help patients with liver, gallbladder, and bile duct cancers better understand their diagnosis and treatment options. This new edition of the NCCN Guidelines for Patients® takes the evidence-based, expert consensus...

ACS Commission on Cancer Announces Outstanding Achievement Awards

The Commission on Cancer of the American College of Surgeons (ACS) has granted its 2017 Outstanding Achievement Award to a select group of 16 accredited cancer programs throughout the United States. Award criteria were based on qualitative and quantitative surveys of cancer programs conducted...

Andrea M. Abbott, MD, Joins Fox Chase Cancer Center

The Fox Chase Cancer Center recently announced the addition of Andrea M. Abbott, MD, as Assistant Professor in the Department of Diagnostic Imaging. She joined the team that uses imaging technology to aid in cancer diagnosis, staging, and guidance of treatment. Dr. Abbott comes to Fox Chase after...

Researchers at Baylor Awarded Multiple Grants to Study Treatment Resistance in Breast Cancer

To better understand the causes of resistance to treatment in estrogen receptor–positive breast cancer, the Department of Defense has awarded researchers at Baylor College of Medicine multiple grants to study gene anomalies in estrogen receptor–positive breast cancer that are associated with...

St. Baldrick’s Foundation Announces 2018 Summer Grant Recipients

The St. Baldrick’s Foundation has announced its 2018 summer grant recipients, including seven from Baylor College of Medicine and Texas Children’s Cancer and Hematology Centers. 2018 Recipients Nmazou Ozuah, MD, Assistant Professor of Pediatrics, received an international scholar grant for...

lymphoma
skin cancer

FDA Approves Mogamulizumab-kpkc for Two Rare Types of Non-Hodgkin Lymphoma

Today, the U.S. Food and Drug Administration approved mogamulizumab-kpkc (Poteligeo) injection for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy. This approval provides a new...

solid tumors
hematologic malignancies

FDA Warns of Increased Risk of Cancer Relapse With Long-Term Use of Azithromycin After Allogeneic Stem Cell Transplant

The U.S. Food and Drug Administration (FDA) is warning that the antibiotic azithromycin should not be given on a long-term basis to prevent the inflammatory lung condition bronchiolitis obliterans syndrome in patients with cancers of the blood or lymph nodes who undergo a donor stem cell...

skin cancer
issues in oncology

Research Finds Failings in Some Apps Used for the Diagnosis of Skin Cancer

In the scramble to bring successful apps for the diagnosis of skin cancer to market, there is a concern that a lack of testing is risking public safety, according to research led by the University of Birmingham. The research, outlined at the British Association of Dermatologists Annual...

multiple myeloma

New Tool for Assessing Frailty in Patients With Newly Diagnosed Multiple Myeloma

A NEW “frailty index” may predict overall survival for patients newly diagnosed with multiple myeloma, according to a study published in JCO Clinical Cancer Informatics.1 Frailty is a critical factor in treatment decision-making for many patients with multiple myeloma, as many of these patients are ...

symptom management
head and neck cancer

Expert Point of View: Rajesh Lalla, DDS, PhD

COMMENTING ON the results of this trial of GC4419, Rajesh V. Lalla, DDS, PhD, President of the Multinational Association of Supportive Care in Cancer, said, “This study demonstrated this agent’s strong potential for the management of oral mucositis in patients receiving head and neck radiation...

lymphoma

More Antibody-Drug Conjugates Expected to Impact Treatment of Lymphoma

FOR THE TREATMENT of lymphoma, antibody-drug conjugates (ADCs) are becoming an important class of drugs, as described at the 2018 Pan Pacific Lymphoma Conference by Brad Kahl, MD, Professor of Medicine at Washington University School of Medicine, St. Louis.1  “We have one ADC—brentuximab vedotin...

Rebecca Yang, MD, Joins Atlantic Health System

BREAST SURGEON Rebecca C. Yang, MD, has joined Atlantic Breast Associates at Overlook Medical Center and Carol G. Simon Cancer Center, part of Atlantic Health System Cancer Care, in New Jersey. Dr. Yang is a board-certified general surgeon and fellowship-trained breast surgeon. She joins Atlantic...

The US Oncology Network Promotes Marcus Neubauer, MD, to Chief Medical Officer

THE US ONCOLOGY Network recently announced the appointment of Marcus Neubauer, MD, as Chief Medical Officer, building on its mission of delivering a comprehensive approach to cancer care. Michael Seiden, MD, PhD, will continue to lead The US Oncology Network as its President.  Dr. Neubauer has...

issues in oncology

Medical Preparedness for Nuclear Disaster

ROBERT PETER GALE, MD, PhD, DSc (hc), was on the faculty of the University of California, Los Angeles, School of Medicine for 20 years and has served as Chairman of the Scientific Advisory Committee of the Center for International Blood and Marrow Transplant Research. In 1986, he was asked by the...

issues in oncology
legislation

Why Oncologists Should Decline to Participate in the Right to Try Act

ON MAY 30, 2018, President Donald J. Trump signed into law the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017.1 This law creates an additional and alternative pathway for patients with a “life-threatening disease or condition” to access...

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