FDA Grants Accelerated Approval to Retifanlimab-Dlwr for Metastatic or Recurrent Locally Advanced Merkel Cell Carcinoma
On March 22, 2023, the U.S. Food and Drug Administration (FDA) granted accelerated approval to retifanlimab-dlwr (Zynyz®) for adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).
FDA Updates Mammography Regulations to Promote Better Screenings and Communication for Patients
The U.S. Food and Drug Administration updated its mammography regulations in March 2023 to require institutions to notify patients about their breast density. The updated regulations strengthen FDA’s oversight and enforcement of institutions and help healthcare providers better categorize and assess mammograms.
FDA Approves Dabrafenib With Trametinib for Pediatric Patients With Low-Grade Glioma and a BRAF V600E Variant
On March 16, 2023, the U.S. Food and Drug Administration approved dabrafenib (Tafinlar®) with trametinib (Mekinist®) for pediatric patients aged one year and older with low-grade glioma (LGG) that have a BRAF V600E variant who require systemic therapy. FDA also approved new oral formulations of both drugs for patients who cannot swallow pills. It is the first FDA approval of a systemic therapy for first-line treatment of pediatric patients with LGG that have a BRAF V600E variant.
Thousands of Fraudulent Nursing Diplomas Distributed in Fake Nursing License Scheme
More than two dozen people were charged for alleged participation in a wire fraud scheme that created an illegal licensing and employment shortcut for nursing candidates following an investigation launched by the U.S. Department of Health and Human Services Office of Inspector General and law enforcement in January 2023.
FDA Expands Early Breast Cancer Indication for Abemaciclib With Endocrine Therapy
On March 3, 2023, the U.S. Food and Drug Administration approved abemaciclib (Verzenio®) in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, early breast cancer who are at high risk for recurrence.
Gamification Helps Oncology Nurses Retain Their Cancer Knowledge and Best Practices
Whether it’s through conferences, podcasts, or journals and other articles, an oncology nurse’s quest for continuing their cancer care learning is ever extensive. Innovative educational methods like gamification can keep training fresh and encourage teamwork.
Oncology Drug Reference Sheet: Futibatinib
Patients with rare cancers like intrahepatic cholangiocarcinoma seldom have many additional treatment options if their tumors become resistant to first-line therapy: From August 1, 2021–July 31, 2022, the U.S. Food and Drug Administration approved only five new agents or indications for rare tumors. On September 30, 2022, FDA added one more, giving futibatinib (Lytgobi™) accelerated approval for adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 gene fusions or other rearrangements. The approval was based on the drug’s 42% overall response rate and median duration of response of 9.7 months.
Tip Sheet Helps Nurses Confront Systemic Racism by Providing Equitable Hair Care
Maintaining a patient’s personal grooming during an inpatient stay is an important aspect of holistic nursing care, but nurses and hospitals alike may fall short when it comes to textured hair care, nurses reported in the American Journal of Nursing.
Nurse-Led Bone Marrow Biopsy Clinics Truncate Time for Testing, Treatment
Patients with suspected hematologic cancers complete the bone marrow biopsy processes and begin treatment more than one month sooner when the procedures are shifted from interventional radiology to a dedicated, nurse-led bone marrow biopsy clinic, researchers reported in a poster presentation at the Association of VA Hematology/Oncology meeting.
Postdischarge ICI Patient Education Eliminates Hospital Readmissions
None of the patients who were admitted for an immune checkpoint inhibitor–related toxicity but received structured teaching at discharge were subsequently readmitted within 30 days, compared to nearly 50% of patients who did not receive teaching, ONS member Michelle L. Rohlfs, DNP, APRN, FNP-BC, AOCNP®, reported in study findings published in the Clinical Journal of Oncology Nursing.
FDA Grants Regular Approval to Dostarlimab-Gxly for dMMR Endometrial Cancer
On February 9, 2023, the U.S. Food and Drug Administration approved dostarlimab-gxly (Jemperli®) for adult patients with mismatch repair deficient recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.
Smiths Medical Recalls More Than 19 Million CADD System Administration Sets and Cassette Reservoirs Because of Medication Delivery Issues
On February 2, 2023, the U.S. Food and Drug Administration reported Smiths Medical’s recall of its CADD™ infusion system administration sets and cassette reservoirs because of tubing occlusions that may under- or not deliver medication and false no disposable attached alarms that may prevent pump use. FDA identified it as a class I recall, the most serious type of recall, where use may cause serious injuries or death.
How Nurses and Administrators Can Respond to the Prevalence of Violence in Health Care
As a clinician in inpatient cardiovascular and acute care nursing and as a healthcare administrator, like many of my colleagues across the nation, I have encountered many violent situations in the workplace. Healthcare workers account for 73% of all violence-related nonfatal workplace injuries and illnesses, and nurses bear the brunt of that statistic, with 44% reporting physical violence and 68% reporting verbal. In fact, in 2022, more than two nurses were assaulted every hour. The rate of violence-related injuries is higher in health care than in all other occupational settings. But data often reflects reported incidents of violence. Its true prevalence is likely much higher because workers may believe that violence is part of the job and don’t report events, and not all events cause an injury.
Violence in Nursing
Across all nursing specialties and settings, 60% of nurses reported experiencing an incident of workplace bullying and incivility and 29% confronted at least one incident of violence in 2022, according to the American Nurses Foundation 2022 Workplace Survey report. And it’s escalating—violence against hospital employees and healthcare professionals has increased since the onset of the COVID-19 pandemic in early 2020, with 44% of nurses reporting having experienced physical violence and 67% verbal abuse between February and June 2020 alone.
Biden-Harris Administration’s COVID-19 Winter Preparedness Plan Improves Resource Availability
To try to get ahead of a feared increase of COVID-19 cases over the winter, the Biden-Harris administration released a COVID-19 winter preparedness plan in December 2022 that focuses on making vaccinations, testing, and other resources easily accessible.
Use Motivational Interviewing to Tailor Your Conversations to Your Patients’ Unique Needs
People encounter significant changes after being diagnosed with cancer. Oncology nurses can help patients and caregivers adapt by using motivational interviewing–based communication strategies.
FDA Approves Elacestrant for ER-Positive, HER2-Negative, ESR1-Variant Advanced or Metastatic Breast Cancer
On January 27, 2023, the U.S. Food and Drug Administration approved elacestrant (Orserdu®) for postmenopausal women or adult men with estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-variant advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
Focus on COVID-19 Prevention Intensifies for Patients With Cancer as FDA Removes Emergency Use Authorization for Evushield
On January 26, 2023 the U.S. Food and Drug Administration removed its emergency use authorization of tixagevimab/cilgavimab (Evushield) for the prevention of SARS-CoV-2 infection after exposure to the virus. FDA said it made the decision because the agent is not effective in preventing infections from the current variants that are responsible for 90% of today’s infections and because the risks of the drug’s side effects do not outweigh the benefits.
FDA Approves Pembrolizumab as Adjuvant Treatment for Non-Small Cell Lung Cancer
On January 26, 2023, the U.S. Food and Drug Administration approved pembrolizumab (Keytruda®) for adjuvant treatment following resection and platinum-based chemotherapy of patients with stage IB (T2a ≥ 4 cm), II, or IIIA non-small cell lung cancer.
FDA Grants Accelerated Approval to Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma
On January 27, 2023, the U.S. Food and Drug Administration granted accelerated approval to pirtobrutinib (Jaypirca®) for relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase inhibitor.
CMS Releases Memo on Workplace Violence Requirements for Hospitals
To combat the increasing incidence of healthcare workplace violence, hospitals must “identify patients at risk for intentional harm to self or others, identify environmental safety risks for such patients, and provide education and training for staff and volunteers” so that workers can deliver care in a safe setting, the Centers for Medicaid and Medicare Services’ (CMS) Quality, Safety, and Oversight Group (QSOG) and Survey and Operations Group (SOG) said in a November 2022 memo.
Oncology Drug Reference Sheet: Darolutamide
On August 5, 2022, the U.S. Food and Drug Administration approved darolutamide (Nubeqa®) in combination with docetaxel in adults with metastatic hormone-sensitive prostate cancer. The approval was based on clinical trial findings demonstrating that the agent improved overall survival and significantly delayed time to pain progression compared to placebo.
Use Active Listening to Engage More Deeply in Patient Discussions
In your day-to-day conversations with patients, colleagues, or even friends and family at home, are you merely hearing what others tell you or are you actively listening to them? When we actively listen to what someone is saying, we intreat curiosity about their words and the emotions they are communicating with their tone and body language. Active listening engages a whole-person connection, whereas passive listening relies on the brain’s ability to catch the main points of a conversation.
FDA Approves Zanubrutinib for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
On January 19, 2023, the U.S. Food and Drug Administration approved zanubrutinib (Brukinsa®) for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
FDA Grants Accelerated Approval to Tucatinib With Trastuzumab for Colorectal Cancer
On January 19, 2023, the U.S. Food and Drug Administration granted accelerated approval to tucatinib (Tukysa®) in combination with trastuzumab for RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
Genetic Disorder Reference Sheet: BAP1
Isolated in 1998 as a tumor suppressor gene, BAP1 pathogenic variants have been identified in at least 200 families. More cases will be found as germline pathogenic variant testing becomes more readily available and routinely offered to patients with cancer.
Religious Fasting During Cancer Treatment
Many cultures and religions across the world practice fasting, or the absence of caloric intake for a few hours to several weeks, at different times throughout the year. Islam, Judaism, Buddhism, Christianity, Hinduism, and Taoism religions most commonly use fasting for various reasons, but the overall purpose generally is to demonstrate sacrifice or spiritual cleansing.
Clinical and Pharmaceutical Nurse Educators Collaborate to Bring Training to Nurses and Improve Patient Care
In 2022 we celebrated the National League for Nursing’s Year of the Nurse Educator, but nursing staff recognize and thank nurse educators for their critical role in training and support year in and year out. Oncology nurses in particular rely on nurse educators to stay updated as treatments and patient care constantly evolve—and that requires a multipronged approach. All aspects are covered when clinical nurse educators and pharmaceutical nurse educators come together to deliver training for today’s cancer therapies.
Smiths Medical Issues Urgent Medical Device Correction Letter About Potential Issues With CADD™ Infusion Sets
On January 5, 2022, the U.S. Food and Drug Administration reported that Smiths Medical issued a December 12, 2022, urgent medical device correction letter to notify customers of two potential issues with CADD infusion system infusion sets because of potential under or no delivery and false no-disposable-attached alarms.
Spectrum Laboratory Products, Inc., Issues Voluntary Recall of Epinephrine USP, Bulk API, Because of Product Discoloration
On January 9, 2022, the U.S. Food and Drug Administration reported that Spectrum Laboratory Products, Inc., issued a voluntarily recall of three lots of epinephrine (l-adrenaline), USP, used to manufacture or compound prescription products, at the user level because of customer reports that the product is discolored.
Oncology Nurse Joins Panel to Discuss Solutions to Advance Equitable Cancer Care for the LGBTQ+ Community
ONS member Ryne Wilson, DNP, RN, OCN®, care coordinator at University of Minnesota Physicians, joined an expert panel to discuss policy solutions for advancing equitable cancer care for the LGBTQ+ community during the National Comprehensive Cancer Network Patient Advocacy Summit in December 2022. The panel focused on issues affecting LGBTQ+ people with cancer, including homophobia, transphobia, systemic racism, and social determinants of health.
The Case of the PARP Inhibitor Adherence Assistance
Mei is a 67-year-old patient who recently underwent an exploratory laparotomy, total abdominal hysterectomy, bilateral salpingo-oophorectomy, omentectomy, and tumor debulking. Her surgical specimens were sent for pathology review and germline biomarker testing. Based on the findings, Mei was diagnosed with stage IIIC, high-grade serous epithelial ovarian cancer with a BRCA1 pathogenic germline variant.
Text-Messaging Prescreening Streamlines Treatment Visits and Care for ICI Toxicities
Prescreening patients for immune-related adverse events during treatment with immune checkpoint inhibitors using text messaging may reduce the need for some in-person, preinfusion office visits, researchers reported in JAMA Network Open. The approach may help decrease the burden of cancer care for both patients and providers.
Latest CDC Clinical Practice Guideline Facilitates Safe Use of Opioids for Pain
Giving providers the latest evidence to inform the safe use and management of opioid prescriptions for cancer-related and other types of short- and long-term pain, the Centers for Disease Control and Prevention updated and expanded its recommendations in November 2022. The updated information was published in the CDC Clinical Practice Guideline for Prescribing Opioids for Pain, which replaces the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain.
FDA Grants Accelerated Approval to Mosunetuzumab-Axgb for Relapsed or Refractory Follicular Lymphoma
On December 22, 2022, the U.S. Food and Drug Administration granted accelerated approval to mosunetuzumab-axgb (Lunsumio®), a bispecific, CD20-directed, CD3 T-cell engager for adult patients with relapsed or refractory follicular lymphoma who’ve received two or more lines of systemic therapy.
Hospira, Inc., Issues Voluntary Nationwide Recall for One Lot of Vancomycin Hydrochloride Injection, USP 1.5 g
On December 22, 2022, the U.S. Food and Drug Administration reported that Hospira, Inc., a Pfizer company, issued a voluntarily recall of one lot of vancomycin hydrochloride injection, USP, 1.5 g, single-dose flip-top vial, at the consumer level. Hospira, Inc., issued the recall because a report of two glass particulates observed in a single vial.
Accord Healthcare, Inc., Issues Voluntary Recall for Lot of Daptomycin for Injection
On December 22, 2022, the U.S. Food and Drug Administration (FDA) reported Accord Healthcare, Inc.’s, voluntarily recall of a single lot of daptomycin for injection 500 mg and 350 mg vials at the consumer level because vials labeled as “daptomycin for injection 500 mg/vial” were found in cartons labeled “daptomycin for injection 350 mg/vial.”
Demonstrate Your Scope of Practice by Becoming an Oncology Certified Nurse
In the years following their initial licensure, nurses will often pursue certification. Obtaining certification shows a nurse’s commitment to their profession, specialty, and patients. Along with showing their commitment, certifications validate a nurse’s qualification and knowledge of a specific area.
Licensure, Scope of Practice, and Reporting
Your nursing career might take many paths, but they all share a primary entry into professional practice: licensure. Licensure verifies that an RN understands and adheres to the laws and statutes that govern their profession as outlined in their state’s nurse practice act. In addition to defining your full scope of practice, your RN license also enables you to fully use your voice and advocate for your patients, as well as report medical errors in practice—both essential responsibilities when providing high-quality cancer care.
Build Your Confidence in Next-Generation Sequencing With Nursing Toolkits and Resources
Essential biomarker testing technologies like next-generation sequencing are increasing our comprehension of cancer genetics and genomics. Biomarker testing results provide prognostic and predictive information about a tumor’s biology and growth to guide treatment decisions. Patients with cancer are turning to their oncology nurses to help them understand their complex test results and corresponding recommended treatment plans, yet many oncology nurses have minimal, if any, formal training in the area.
Oncology APRNs Are Change Agents for Tobacco Cessation
Whether by cigarette, pipe, cigar, or vaping device, tobacco use is a major risk factor for the development of many cancers; increases cancer mortality, risk of recurrence, and second primary cancers; adversely affects treatment outcomes for surgery, radiation, and chemotherapy; and affects other chronic health conditions. Initiating smoking cessation at the time of a lung cancer diagnosis improves overall survival by 30%–40%, yet 40%–50% of smokers continue to use tobacco after diagnosis.
Redefining the Bell Makes the Ritual Inclusive for All Patients With Cancer
Patients often report mixed feelings about “ringing the bell” to signify completion of their cancer treatment: It’s a joyous moment, but they may have underlying apprehension, too. And other patients may never have a chance to ring the bell if their cancer progresses despite receiving the best possible care.
Chemo Combo May Be a Bladder Cancer Treatment Alternative During BCG Shortage
Overall survival among patients with non–muscle-invasive bladder cancer who are treated with adjuvant gemcitabine and docetaxel is comparable to overall survival for treatment with bacillus Calmette-Guérin (BCG), researchers reported in the Journal of Urology. The evidence could support a treatment alternative for high-risk patients during the BCG shortage.
Oncology Drug Reference Sheet: Dostarlimab-Gxly
More than 40% of adult patients with mismatch repair deficient recurrent or advanced endometrial cancer had an overall response receiving dostarlimab-gxly (Jemperli), and more than 90% of those lasted six months or longer during the drug’s clinical trials. Those results led the U.S. Food and Drug Administration to grant the agent its original accelerated approval in 2021 for the indication. FDA expanded the accelerated approval later that year to include all recurrent or advanced solid tumors with dMMR demonstrated through an FDA-approved diagnostic test.
FDA Approves Updated Drug Labeling Including New Indications and Dosing Regimens for Capecitabine Tablets Under Project Renewal
On December 14, 2022, the U.S. Food and Drug Administration approved updated labeling for capecitabine tablets (Xeloda®) under Project Renewal, an Oncology Center of Excellence (OCE) initiative aimed at updating labeling information for certain older oncology drugs to ensure information is clinically meaningful and scientifically up to date. Capecitabine is the first drug to receive a labeling update under the pilot program.
FDA Approves Atezolizumab for Alveolar Soft Part Sarcoma
On December 9, 2022, the U.S. Food and Drug Administration approved atezolizumab (Tecentriq®) for adult and pediatric patients aged 2 years and older with unresectable or metastatic alveolar soft part sarcoma.
Overcome Inequalities in Cancer Treatment Options Across the Ages
Larry is an 83-year-old rancher who was diagnosed with pancreatic adenocarcinoma and treated with gemcitabine and nab-paclitaxel. A three-month follow-up scan reveals recurrent disease. Larry’s son tells you he wants to explore clinical trials but is frustrated that several promising trials do not accept patients older than 70 years. He asks you why a person’s chronologic age is a major exclusion factor and their performance status is only considered after they meet the age criteria. He also asks you whether his father’s age influenced the choice between first-line therapy with FOLFIRINOX or gemcitabine and nab-paclitaxel.
Oncology Nurse Navigator Roles Are Transforming Cancer Outcomes for Underserved Rural Patients
Underserved, rural, and economically disadvantaged patients with cancer who are under the care of an oncology nurse navigator are better prepared to begin treatment and require fewer services than non-navigated peers, according to study findings published in the Oncology Nursing Forum (ONF). Authors Williams et al. said that their results indicate greater patient satisfaction.
Engaging Community Health Workers Reduces Hospitalizations, Increases Psychosocial, Palliative, and EOL Care
Patients with advanced cancer who met with community health workers between their regular cancer care appointments were less likely to require acute care and more likely to participate in advance care planning and receive mental health, palliative, and hospice care, according to study findings published in JAMA Oncology.