Biden Brings Robert Califf Back to FDA
Citing his extensive medical background and leadership experience, in November 2021, President Joe Biden nominated Robert Califf, MD, MACC, adjunct professor of medicine, professor of cardiology, and member of the Duke Clinical Research Institute at the Duke University School of Medicine in Durham, NC, as U.S. Food and Drug Administration (FDA) commissioner. Califf will assume the role once confirmed by the U.S. Senate.
FDA Approves Sirolimus Protein-Bound Particles for Malignant Perivascular Epithelioid Cell Tumor
On November 22, 2021, the U.S. Food and Drug Administration (FDA) approved sirolimus protein-bound particles for injectable suspension (Fyarro™) for adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).
Genetic Disorder Reference Sheet: Familial Adenomatous Polyposis
Individuals with 10–100+ polyps may have a germline pathogenic variant in the APC gene, placing them at higher risk for developing colorectal, gastrointestinal, and other cancers. The condition is known as familial adenosis polyposis (FAP), and loss of function in the APC gene is the first step in the adenoma-to-carcinoma sequence. Some people have an attenuated form (aFAP), with delayed polyp growth and fewer polyps (see sidebar). As many as 20% are de novo, meaning that they are the first in their family to have an identified pathogenic variant.
Bringing Biosignatures to the Bedside
With the growth of genomics and targeted therapy, nurse scientists are gaining deeper understanding the vast facets of patients’ symptom experience, and biosignatures could be the key to unlocking the next frontier in symptom science research.
Combination Immunotherapy May Further Increase Melanoma Survival Length
Using two agents that target two different receptors more than doubles length of survival for advanced melanoma than a single agent alone, researchers reported at the 2021 American Society of Clinical Oncology annual meeting.
Genetic Disorder Reference Sheet: ATM Pathogenic Variants
An estimated 1%–2% of adults have one pathogenic ataxia telangiectasia mutated (ATM) gene variant (heterozygous) and are considered carriers. People who are homozygous (two altered copies) have ataxia-telangiectasia (A-T), a hereditary condition that often appears in childhood and is characterized by progressive neurologic problems that lead to difficulty walking and an increased risk for developing various malignancies. Children with A-T may begin staggering and appear unsteady (ataxia) shortly after learning to walk.
FDA Reports Worldwide Recall of Lidocaine HCl Topical Solution 4% Because of Super Potency
On October 13, 2021, the U.S. Food and Drug Administration (FDA) reported Teligent Pharma’s voluntary recall of five lots of lidocaine HCl topical solution 4% in a 50 ml screw cap glass bottle to the user level because the firm’s testing found it to be super potent based on an out-of-specification result obtained at the 18-month stability timepoint.
HER2 Therapies May Be Effective in a Variety of Solid Tumors
Researchers have found that 2%–3% of all solid tumors overexpress or amplify HER2 protein that may be a target for drugs such as pertuzumab and trastuzumab, particularly in KRAS-variant disease. They presented their findings during the 2021 American Society of Clinical Oncology annual meeting.
Pilot Study Shows Positive Impact of ONS Get Up, Get Moving Campaign
PITTSBURGH, PA—October 12, 2021—Research shows that physical activity during cancer treatment mitigates some of the negative physical and psychosocial outcomes associated with diagnosis and treatment. Released in the October 2021 issue of the Clinical Journal of Oncology Nursing, results of a pilot study by Judi K. Forner, DNP, APRN, ACNS-BC, RN-BC, Andrea Doughty, PhD, Matthew David Dalstrom, PhD, MPH, Brandie L. Messer, DNP, RN, PCOE, and Shannon K. Lizer, PhD, APRN, FNP-BC, FAANP, demonstrated the positive impact of the Oncology Nursing Society’s (ONS’s) Get Up, Get Moving program.
It Takes a Team to Confront Moral Distress
Unbearable levels of stress, burnout, frustration, disappointment, and even fear are plaguing today’s healthcare providers more than ever before. But for oncology nurses, moral distress and compassion fatigue have always been in the background when caring for patients with a serious illness.
PhD and DNP Students Collaborate to Implement Practice-Driven Research
Evidence-based practice is dual sided: nurse scientists conduct research, and clinical nurses implement those findings into practice. Working together, they improve care by developing cancer survivorship programs, reducing cancer risk, and assessing cancer care in vulnerable populations. The University of Washington School of Nursing’s (UW SoN’s) partnership with Confluence Health, one of the largest healthcare providers in north central Washington, built a novel program to identify gaps in research and implementation and elicit projects that influence healthcare outcomes.
FDA Issues Marketing Denial Orders for 55,000 Flavored E-Cigarette Products
In August 2021, the U.S. Food and Drug Administration (FDA) denied about 55,000 flavored e-cigarette products’ marketing applications for failing to provide evidence that they appropriately protect public health.
FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations
On September 22, 2021, the U.S. Food and Drug Administration (FDA) granted emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine for use as a single booster dose administered at least six months after completion of the primary series in individuals aged 65 and older, individuals aged 18–64 at high risk for severe COVID-19, and individuals aged 18–64 whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk for serious complications of COVID-19 or severe COVID-19.
What the Evidence Says for Traditional Chinese Medicine Ma Zi Ren Wan for Constipation
A common and distressing symptom among patients with a variety of health diagnoses as well as the general population, constipation is characterized by reduced stool frequency, incomplete evacuation, straining, and a sense of anorectal blockage. Nearly 43%–58% of patients with cancer report constipation caused by a variety of factors, including organic, functional, or drug associated. Standard treatment options such as fiber supplements, laxatives, and stool softeners are not entirely effective and can cause adverse effects.
FDA Reprimands Tobacco Company for Not Meeting Premarketing Filing Requirements
On August 9, 2021, the U.S. Food and Drug Administration issued a refuse-to-file letter (RTF) to JD Nova Group, notifying the company that their premarket tobacco product applications associated with approximately 4.5 million of their products do not meet the filing requirements for a new tobacco product seeking a marketing order.
How One Organization Developed Tools to Predict Opioid Use Disorder Among Patients
Opioids are one strategy to help manage the cancer-related pain that nearly 75% of patients with cancer experience throughout the disease or its treatment. However, the prevalence of opioid misuse disorder (OUD) among patients with cancer is believed to be at least equal to that of the general population, Debra Rodrigue, MA, RN-BC, AOCNS®, explained during a session for the ONS BridgeTM virtual conference on September 9, 2021.
Prognostic Biomarkers May Help Predict Rhabdomyosarcoma Outcomes
TP53 and MYOD1 variants are associated with more aggressive forms of rhabdomyosarcoma, a rare childhood cancer, and poorer outcomes, according to the results of the largest international genomic profiling study of the disease. The findings, which were published in the Journal of Clinical Oncology, have implications for somatic biomarker testing to guide tailored treatment approaches.
BTK Inhibitor Effective for Relapsed Hairy Cell Leukemia
Ibrutinib produces durable disease control for patients with high-risk hairy cell leukemia, a rare cancer, who have relapsed and for whom standard purine analogues are not a feasible therapeutic option, according to study results published in Blood.
FDA Grants Full Approval for First COVID-19 Vaccine
On August 23, 2021, the U.S. Food and Drug Administration (FDA) approved the Pfizer-BioNTech COVID-19 vaccine, now marketed as Comirnaty, for the prevention of COVID-19 coronavirus infection in individuals aged 16 years and older. The vaccine is still under emergency use authorization (EUA) for individuals aged 12–15 years and as a third dose in certain immunocompromised individuals.
Researchers Study Innate Immunity Throughout History to Determine New Methods of Cancer Treatment
Evolution may be the key to understanding immunity—or at least the National Institutes of Health (NIH) thinks so. Studies of the history of human life could uncover discoveries that have implications for all types of disease, including cancer.
FDA Grants Accelerated Approval to Dostarlimab-gxly for dMMR Advanced Solid Tumors
On August 17, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to dostarlimab-gxly (Jemperli®) for adult patients with mismatch repair deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options.
Whole-Genome Sequencing May Guide Treatment Choices for AML and MDS
When compared to conventional testing on the same samples from patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS), whole-genome sequencing–based testing detected the same abnormalities—and new genetic information in about a quarter of patients, potentially changing treatment selection for more than half of those patients, researchers said in the New England Journal of Medicine.
Overall Youth Tobacco Use Declines, but E-Cigarette Use Climbs, According to National Survey Results
American youth reported a decline in using any tobacco product in 2020 compared to 2019 but no significant decrease in the use of cigarettes, hookah, pipe tobacco, or heated tobacco products, according to 2020 U.S. Food and Drug Administration (FDA) survey findings on youth tobacco use. Despite the decline, FDA said that the data shows “disturbingly high rates of frequent and daily e-cigarette use” and strong nicotine dependence among youth.
Researchers Tie More Cancers, Mortality to NF1 Disorders
The genetic disorder neurofibromatosis type 1 (NF1) is linked to the development of and mortality for more types of cancer than previously identified, researchers reported in results from a new study. They published the findings in JAMA Network Open.
Biden-Harris Administration’s FY 2022 Discretionary Funding Request Includes Proposals to Advance Public Health
In its first year, new presidential administrations release a skinny budget that contains more topline items rather than deep dives into each agency and subdivision. Following suit, in April 2021 the Biden-Harris administration released its request for discretionary funding with limited definition, but it was enough to foreshadow the fiscal year (FY) 2022 funding cycle.
The Seven Dimensions of Rest
Sleep and rest are two different concepts. Society focuses on sleep, but rest is just as important, and not just for the physical body. Rest allows us to nurture our physical, mental, emotional, sensory, creative, social, and spiritual self. Each of those dimensions needs to be consciously rested for a person to truly feel restored.
New Form of CAR T Cells May Target Genetic Alteration Common to All Cancers
Scientists created a new cancer immunotherapy approach that uses a new type of CAR T cells to stimulate an immune response against cells that are missing one gene copy. They reported their findings in Proceedings of the National Academy of Sciences.
What Is CRISPR?
Clustered regularly interspaced short palindromic repeats (CRISPR) is a commonly seen term for readers of science news and literature across a variety of industries. But reading the word often doesn’t automatically translate to understanding it and its implications. Here’s what oncology nurses need to know about CRISPR.
Biden-Harris Administration’s Drug Policy Priorities Support Prevention, Treatment, and Recovery
Prescription overdoses and addiction rates have dramatically increased since 2012, with more than 70,000 deaths attributed to the abuse of fentanyl, opioids, cocaine, and methamphetamine in 2019, a 35% increase since 2015. Addressing drug misuse is a top priority for the Biden-Harris administration, as well as researching systematic inequities in the country’s approach to criminal justice and prevention, treatment, and recovery.
Senate HELP Committee Reviews Federal Agencies’ COVID-19 Response
The Centers for Disease Control and Prevention (CDC) is “committed to continuing to advance the science around COVID-19, moving more vaccines into more communities—especially those communities most at risk for COVID-19 infection—and working to improve health equity,” CDC Director Rochelle Walensky, MD, MPH, said during a March 2021 U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP) hearing. She joined Anthony Fauci, MD, David Kessler, MD, and Peter Marks, MD, PhD, in sharing witness testimonies about their agencies’ response to the pandemic and how to better prepare for future threats.
FDA Approves Belumosudil for Chronic Graft-Versus-Host Disease
On July 16, 2021, the U.S. Food and Drug Administration (FDA) approved belumosudil (RezurockTM), a kinase inhibitor, for the treatment of chronic graft-versus-host disease (chronic GVHD) in adult and pediatric patients 12 years and older after failure of at least two prior lines of systemic therapy.
Long-Term irAEs From Checkpoint Inhibitors Have Considerations for Survivorship
More than 40% of patients with melanoma treated with nivolumab or pembrolizumab experience persistent long-term immune-related adverse events (irAEs) for at least 1.5 years, researchers reported in JAMA Oncology.
Nurse Researcher AIMS to Increase Screening for Malnutrition and Reduce Bowel Dysfunction
Research has identified an association between malnutrition and functional deficits in patients with cancer, regardless of age, and other studies confirm that malnutrition affects treatment tolerability, outcomes, and quality of life for patients with cancer. However, studies have also found that oncology clinicians do not consistently assess for malnutrition and functional deficits in clinical settings.
The Evidence Is Building for ACE Inhibitors in Anthracycline-Associated Cardiotoxicity
Cardiac toxicities are associated with many types of cancer therapies, with both length of and time since treatment increasing a patient’s risk for the adverse event. Anthracycline chemotherapies are among the oldest agents still used for a variety of cancer diagnoses, and as cancer survivorship continues to grow, more patients are presenting with late-onset cardiac complications.
FDA Approves Daratumumab and Hyaluronidase-Fihj With Pomalidomide and Dexamethasone for Multiple Myeloma
On July 9, 2021, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (Darzalex Faspro®) in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor.
FDA Requires E-Cigarette Brands to Provide Information on Social Media Practices
Companies marketing the tobacco brands Aspire, Joyetech, Vaporesso, and Voopoo, which were selected through a systematic process, must share information about social media marketing campaigns that target youth, the U.S. Food and Drug Administration (FDA) announced. The requirements include social media advertising documents and marketing plans, such as planned content to target specific audiences, cost of plans, use of partners and influences, and the number of followers and views broken down by age group.
USPSTF Recommends Colorectal Cancer Screening Should Begin at 45
According to the U.S. Preventive Services Task Force (USPSTF), colorectal cancer is the third leading cause of cancer death for both men and women, with an estimated 52,980 individuals in the U.S. projected to die from the disease in 2021. After evaluating the current evidence and conducting a modeling study, USPSTF updated its recommendations on colorectal cancer screening.
FDA Approves Asparaginase Erwinia Chrysanthemi for Leukemia and Lymphoma
On June 30, 2021, the U.S. Food and Drug Administration (FDA) approved asparaginase erwinia chrysanthemi (recombinant)-rywn (RylazeTM) as a component of a multiagent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients one month or older who have developed hypersensitivity to E. coli-derived asparaginase.
Immunotherapy Extends Survival in Uveal Melanoma
Patients with uveal melanoma who were treated with tebentafusp, an investigational immunotherapy, lived a median 5.7 months longer than those in comparison groups, researchers reported in study findings presented at the American Association for Cancer Research 2021 annual meeting.
FDA Approves Avapritinib for Advanced Systemic Mastocytosis
On June 16, 2021, the U.S. Food and Drug Administration (FDA) approved avapritinib (Ayvakit™) for adult patients with advanced systemic mastocytosis (AdvSM), including patients with aggressive systemic mastocytosis, systemic mastocytosis with an associated hematologic neoplasm, and mast cell leukemia.
Single-Chain Diabodies May Target Variants in Both Solid and Liquid Tumors
Lab-developed antibodies using a single-chain diabody format can target TP53 or RAS variants in solid tumors and T-cell receptor variants in blood cancers, researchers reported in study findings published in Science, Science Immunology, and Science Translational Medicine, respectively.
Big Tobacco Continues to Target Female Smokers, but Oncology Nurses Can Help
More than 16 million people who identify as women and girls in the United States reported smoking in 2021, according to a May 2021 report from the Campaign for Tobacco Free Kids, of which ONS is an active member, who partnered with several leading women’s organizations on the study. Female smokers are also significantly more likely than men to use menthol cigarettes, and e-cigarette use among high school girls rose by 89% from 2017–2020.
The Future of Nursing Charts a Path to Achieve Health Equity
Society in 2021 has been challenged by an economic crisis and the COVID-19 coronavirus pandemic. Today, nurses must have an arsenal of tools and knowledge—and the ability to adapt in unpredictable circumstances—to assist patients seeking health care.
Racial Minorities Receive More Aggressive EOL Ovarian Cancer Care
During the last month of life, non-White patients are more likely to receive aggressive care with little to no focus on palliative or end-of-life (EOL) care for their ovarian cancer, researchers reported in Cancer.
Research Findings Confirm Link Between Communication and Safety
My team’s current project to understand communication in ambulatory oncology settings stems from more than a decade of research (Kamimura et al.), in which we have tried to uncover the factors that facilitate high-quality cancer care for patients and a satisfying practice environment for care teams (Friese).
Multimethod Approach Supports Providers’ Mental Health During COVID-19
Providing variety of methods and approaches allows healthcare workers to choose the best options for them to mitigate and treat psychological distress from the COVID-19 coronavirus pandemic, researchers said in a preliminary report published in the Joint Commission Journal on Quality and Patient Safety.