FDA Approves Nirogacestat as the First Treatment for Desmoid Tumors
On November 27, 2023, the U.S. Food and Drug Administration (FDA) approved nirogacestat (Ogsiveo™) for use in adult patients with progressing desmoid tumors who require systemic treatment. Nirogacestat is the first approved treatment for desmoid tumors.
NS Central Line Flushes Save Nearly $30,000 While Increasing Patient Safety
Switching from heparin to normal saline (NS) as the preferred flushing solution for central venous catheter (CVC) lines in adult ambulatory patients with cancer saved one institution nearly $30,000 without affecting quality of care, researchers reported in the Clinical Journal of Oncology Nursing. The change also increased patient safety by reducing risk of heparin-induced thrombocytopenia or allergic reactions, the authors said.
FDA Warns Not to Use Cardinal Health Monoject Syringes With Syringe Pumps and PCA Pumps
On November 20, 2023, the U.S. Food and Drug Administration (FDA) alerted healthcare providers and facilities not to use Cardinal Health Monoject syringes with syringe pumps and patient-controlled analgesia (PCA) pumps while the agency further evaluates a reported issue. FDA classified it as a class I recall, the most serious type of recall, where use of the product or device may result in serious injury or death.
Genetic Disorder Reference Sheet: BARD1
Located on chromosome 2 with 11 exons, BRCA1-associated ring domain (BARD1) is part of the BRCA1/BARD1 protein complex and associated with breast cancer susceptibility. The protein complex enhances ubiquitin ligase activity, which helps regulate centrosome function, repair DNA, and regulate cell cycles to maintain genetic stability. BARD1 interacts with and stabilizes BRCA1 in the repair of double-strand DNA breaks as part of the homologous recombination pathway.
American Cancer Society Expands Eligibility in Updated Lung Cancer Screening Guideline
People aged 50–80 years who are current smokers or have quit and have a smoking history of 20 or more pack-years should be screened annually with low-dose computed tomography, according to the American Cancer Society’s 2023 updated lung cancer screening guidelines.
FDA Reports Fresenius Medical Care’s Recall of Sanxin Single-Use Syringes
On November 15, 2023, the U.S. Food and Drug Administration (FDA) reported that Fresenius Medical Care is recalling three types of its Sanxin single-use syringes because of leakages. FDA identified it as a class I recall, the most serious type of recall, where use of the devices may cause serious injuries or death.
Standardizing Venous Access Assessment and Validating Safe Chemo Administration Drastically Lowers Rates of Adverse Venous Events
Implementing standardized venous access assessment and validating competency for safe administration of vesicant chemotherapy agents according to practice standards reduces adverse venous events by nearly 80%, ONS members Melissa Arangoa Miller, MS, APRN, ACNS-BC, AOCNS®, Victoria Frazier-Warmack, DNP, MSN, RN, OCN®, and Kathrene Castelo, RN, MSN, OCN®, reported in study findings published in the Clinical Journal of Oncology Nursing.
FDA Amends Pembrolizumab’s Gastric Cancer Indication
On November 7, 2023, the U.S. Food and Drug Administration (FDA) revised the existing indication of pembrolizumab (Keytruda®) with trastuzumab, fluoropyrimidine, and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma. This updated indication, which remains approved under accelerated approval regulations, restricts its use to patients whose tumors express PD-L1 (CPS ≥ 1), as determined by an FDA-approved test.
FDA Approves Fruquintinib in Refractory Metastatic Colorectal Cancer
On November 8, 2023, the U.S. Food and Drug Administration (FDA) approved fruquintinib (Fruzaqla™) for adult patients with metastatic colorectal cancer who received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy.
FDA Announces Teleflex and Arrow International’s Recall of Mislabeled Pressure Injectable Catheter Kits
On November 6, 2023, the U.S. Food and Drug Administration (FDA) announced that Teleflex, and its subsidiary Arrow International, are recalling 1,905 pressure injectable central venous catheter kits due to mislabeling regarding the presence of chlorhexidine in these products. FDA has identified it as a class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
SWAT Teams and Other Strategies to Maintain Difficult Central Lines and Dressings
Central line-associated bloodstream infections (CLABSIs) can cause serious harm or even death to patients and significantly increase healthcare costs. Nurses are critical contributors to infection prevention in any healthcare setting, particularly for oncology’s often-immunocompromised patient population, ONS member MiKaela Olsen, DNP, APRN-CNS, AOCNS®, FAAN, clinical program director for oncology at the Johns Hopkins Hospital and Johns Hopkins Health System in Baltimore, MD, said.
OFS, Examestane Improve Recurrence-Related Outcomes in Premenopausal Breast Cancer
After two trials and more than 12 years of follow-up, researchers concluded that ovarian function suppression (OFS) plus endocrine therapy improves both disease-free (DFS) and overall survival for patients with premenopausal breast cancer compared to endocrine therapy alone and that exemestane has an advantage over tamoxifen for some patients. The authors reported their findings in two articles in the Journal of Clinical Oncology.
Access Devices and Central Lines
Venous access devices are ubiquitous in nearly every direct care nursing setting. But as technology becomes more complex and new evidence emerges, nurses must evaluate it against their current practice: Should I use saline or heparin to flush this access device? Am I placing this peripheral venous catheter correctly? What does the latest evidence say? Do I need to implement a practice change?
Do Not Use Certain Brands of Saline and Sterile Water Medical Products From Nurse Assist Because They May Not Be Sterile, FDA Warns
On November 6, 2023, the U.S. Food and Drug Administration (FDA) announced Nurse Assist, LLC’s, recall and warned consumers, healthcare providers, and healthcare facilities not to use recalled saline (0.9% sodium chloride) and sterile water medical products manufactured by Nurse Assist, LLC, and sold under various brands, because they may not be sterile.
FDA Approves Pembrolizumab With Chemotherapy for Biliary Tract Cancer
On October 31, 2023, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda®) used with gemcitabine and cisplatin for the treatment of locally advanced unresectable or metastatic biliary tract cancer.
FDA Approves Toripalimab-Tpzi for Nasopharyngeal Carcinoma
On October 27, 2023, the U.S. Food and Drug Administration (FDA) approved toripalimab-tpzi (Loqtorz) with cisplatin and gemcitabine for first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma (NPC). FDA also approved toripalimab-tpzi as a single agent for adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy.
FDA Announces Exela’s Nationwide Recall of 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 ml, Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 ml, and Cysteine Hydrochloride Injection, USP 500 mg/10 ml
On October 25, 2023, the U.S. Food and Drug Administration (FDA) announced that Exela Pharma Sciences, LLC (Exela), is voluntarily recalling the following products to the consumer level because it observed silicone particulate matter during routine inspection of retained samples.
FDA Approves Ivosidenib for Myelodysplastic Syndrome
On October 24, 2023, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo®) for the treatment of adult patients with relapsed or refractory myelodysplastic syndrome (MDS) with a susceptible isocitrate dehydrogenase-1 (IDH1) variant, as detected by an FDA-approved test. The agency also approved the Abbott RealTime IDH1 assay as a companion diagnostic device to select patients for ivosidenib treatment.
FDA Approves Nivolumab for Adjuvant Treatment of Stage IIB/C Melanoma
On October 13, 2023, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo®) for the adjuvant treatment of completely resected stage IIB/C melanoma in patients aged 12 years and older.
Patients, Nurses, and Physicians Say Health Insurer Policies Reduce Access to Care
The vast majority of patients, nurses, and physicians said that insurer policies and practices are reducing access to medical care, driving up healthcare costs, and increasing clinician burden and burnout, the American Hospital Association reported in survey results released in July 2023.
Learn How to Read a Somatic Biomarker Testing Report
Join ONS member Suzanne Mahon, RN, AOCN®, AGN-BC, FAAN, professor at Saint Louis University in Missouri and member of the St. Louis ONS Chapter, as she demonstrates how to examine and explore somatic biomarker testing reports. Understanding these reports is critical when providing patient education, and Mahon’s tips and tricks when identifying report components and their importance are helpful tools for oncology nurses to consider in their practice.
Discoveries in Race-Related Breast Cancer Biomarkers May Improve Precision Treatments
Race-specific cellular and genomic characteristics in breast and breast cancer tissues may explain racial differences in breast cancer aggressiveness, blood vessel growth, tumor cell migration and metastasis, and the cancer pathways GLI1 and Notch, researchers said in study findings published in npj Breast Cancer. The findings may help guide the development of even more personalized treatments and address some aspects of cancer’s disparate burden on certain populations.
FDA Safety Communication Provides Recommendations for Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks
On September 29, 2023, the U.S. Food and Drug Administration (FDA) issued an updated safety communication to consumers, healthcare providers, and facilities about certain surgical N95 respirators and masks manufactured by Owens and Minor (O&M) Halyard. FDA updated its recommendations for the products based on new data and information from O&M Halyard.
FDA Approves Bosutinib for Pediatric Patients With Chronic Myelogenous Leukemia
On September 26, 2023, the U.S. Food and Drug Administration (FDA) approved bosutinib (Bosulif®) for pediatric patients aged 1 year and older with chronic phase Ph+ chronic myelogenous leukemia that is newly diagnosed or resistant or intolerant to prior therapy. FDA also approved a new 50 mg and 100 mg capsule dosage form.
Novartis Issues Voluntary Nationwide Recall of One Lot of Cyclosporine Oral Solution
On September 11, 2023, the U.S. Food and Drug Administration announced Novartis’s voluntary nationwide recall at the consumer level of one lot of its Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/ml, in the United States because of observations of crystals in some bottles that could result in incorrect dosing. No other cyclosporine oral solution formulations are affected.
Genetic Disorder Reference Sheet: Neurofibromatosis Type 1
Neurofibromatosis type 1 (NF1) is an autosomal dominant condition that stems from a pathogenic variant in the NF1 gene, which regulates the production of the tumor-suppressing neurofibromin protein. NF1 disorder is characterized by pigmentation changes (e.g., café au lait spots; see image), cutaneous neurofibromas, malignant nerve sheath tumors, gastrointestinal stromal tumors, and intellectual disorders. Signs and symptoms vary widely, but NF1 disorders occur in 1 in about 3,000–4,000 people. Almost half of the cases are de novo.
How Our Personal Biases Affect Our Well-Being and Patient-Centered Care
As oncology nurses, our personal biases can affect not only our own brains and cognitive functioning but also the mental health of those we interact with. We all have biases, or preconceived notions or ideas about particular people, groups, or circumstances. They frequently result from prior experiences, cultural and societal influences, and societal conditioning.
Oncology Drug Reference Sheet: Pirobrutinib
In clinical trials, pirobrutinib (Jaypirca™) was effective in restoring BTK inhibition in patients that experienced progression after previously receiving a covalent BTK inhibitor. Pirobrutinib became the first-available noncovalent (reversible) BTK inhibitor in January 2023 when the U.S. Food and Drug Administration granted it accelerated approval.
Learn How to Conduct Mock Code Simulations
Join ONS member Ashley Barill, BSN, OCN®, nurse supervisor at WVU Medicine in Morgantown, WV, as she explains how she and her team train using mock code simulations in an outpatient infusion center in this video. Mock code simulations can help oncology nurses and other healthcare professionals prepare for emergencies, and Barill’s tips and resources are helpful tools when conducting those simulations.
FDA Approves Melphalan as a Liver-Directed Treatment for Uveal Melanoma
On August 14, 2023, the U.S. Food and Drug Administration approved melphalan (Hepzato™) for injection or hepatic delivery system (Hepzato Kit) containing melphalan as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.
FDA Grants Accelerated Approval to Elranatamab-Bcmm for Multiple Myeloma
On August 14, 2023, the U.S. Food and Drug Administration (FDA) granted accelerated approval to elranatamab-bcmm (Elrexfio™), a bispecific B-cell maturation antigen-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
FDA Approves Niraparib and Abiraterone Acetate Plus Prednisone for BRCA-Variant Metastatic Castration-Resistant Prostate Cancer
On August 11, 2023, the U.S. Food and Drug Administration (FDA) approved the fixed dose combination of niraparib and abiraterone acetate (Akeega™) plus prednisone for adult patients with deleterious or suspected deleterious BRCA variant metastatic castration-resistant prostate cancer, as determined by an FDA-approved test.
Baxter Healthcare Corporation Recalls SIGMA Spectrum Infusion Pumps and IQ Infusion Systems With Dose IQ Safety Software, Issues Corrected Software
On August 1, 2023, the U.S. Food and Drug Administration (FDA) reported Baxter Healthcare Corporation’s June 15, 2023, recall of SIGMA Spectrum infusion pumps with master drug library (version 8) and Spectrum IQ infusion systems with dose IQ safety software (version 9) because of false alarms for upstream occlusion after pump software upgrades to version v8.01.01 and v9.02.01, respectively. FDA identified it as a class I recall, the most serious type of recall, where use of the devices may cause serious injuries or death.
A growing literature base supports the use of medical cannabis in cancer care and symptom management, and as of April 2023, 42 states, including 3 territories and the District of Columbia, allow for medical use. As more patients use or seek to use medical cannabis during their cancer trajectory, oncology nurses are looking to the latest research behind medical cannabis, how cannabis can impact their patients’ treatment plans and symptom management, and legislation in the state in which they practice.
FDA Approves Quizartinib for Newly Diagnosed Acute Myeloid Leukemia
On July 20, 2023, the U.S. Food and Drug Administration (FDA) approved quizartinib (Vanflyta®) in combination with standard cytarabine and anthracycline induction and cytarabine consolidation and as maintenance monotherapy following consolidation chemotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukemia that are FLT3 internal tandem duplication-positive, as detected by an FDA-approved test. FDA also approved the LeukoStrat CDx FLT3 variant assay as a companion diagnostic for quizartinib.
Oncology Nurses Lead Interprofessional Team to Drastically Increase Cancer Screenings in Rural Patients
Remote educational outreach involving oncology nurse–developed videos and follow-up navigator phone calls increased breast, cervical, and colorectal cancer screening adherence compared to usual care in females obtaining community care in rural Ohio and Indiana locations, according to study findings published in JAMA Network Open.
Respect Patients’ Religious Hair Wraps or Coverings When Taking Accurate Height and Weight Measurements
Patients who follow various religious practices may wear head coverings that can affect their height or weight measurements. Accurate height and weight measurements are essential for weight-based medication dosing to prevent inadvertent over- or underdosing.
Nurse Cosponsors Resolution on Telehealth in the U.S. House of Representatives
A geriatric nurse practitioner who served as a Navy helicopter pilot in the Persian Gulf through two deployments, U.S. Representative Jen Kiggans (R-VA) introduced new legislation that would allow more providers to use telehealth services, expanding access and reducing barriers for their patients.
Learn How to Read a Germline Genomic Testing Report
Join ONS member Suzanne Mahon, RN, AOCN®, AGN-BC, FAAN, professor at Saint Louis University in Missouri and member of the St. Louis ONS Chapter, as she demonstrates how to examine and explore germline genomic testing reports. Understanding these reports is critical when providing patient education, and Mahon’s tips and tricks when identifying report components and their importance are helpful tools for oncology nurses to consider in their practice.
Oncology Nurses Teach Correctional Facility Nurses to Safely Administer Chemo
A combination of intensive chemotherapy immunotherapy administration education and shorter training on oncology symptom management can prepare correctional facility nurses to safely care for patients with cancer in the community, according to presenters in an oral abstract session at the 48th Annual ONS Congress® in April 2023.
Veterans and Cancer
Veterans and active service members of the U.S. armed forces have dedicated their lives to the safety and freedom of their country. However, that honorable service may place them at risk for post-traumatic stress disorder, anxiety, depression, and cancer.
Oncology Drug Reference Sheet: Teclistamab-Cqyv
With an estimated duration of response rate of 90.6% at six months and 66.5% at nine months in the agent’s clinical trials, in October 2022, the U.S. Food and Drug Administration granted accelerated approval to teclistamab-cqyv (Tecvayli™) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four previous lines of therapy.
FDA Approves Talazoparib With Enzalutamide for HRR Gene–Variant Metastatic Castration-Resistant Prostate Cancer
On June 20, 2023, the U.S. Food and Drug Administration approved talazoparib (Talzenna®) with enzalutamide for homologous recombination repair gene–variant metastatic, castration-resistant prostate cancer.
FDA Grants Accelerated Approval to Glofitamab-Gxbm for Selected Relapsed or Refractory Large B-Cell Lymphomas
On June 15, 2023, the U.S. Food and Drug Administration granted accelerated approval to glofitamab-gxbm (Columvi™) for relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, or large B-cell lymphoma arising from follicular lymphoma after two or more lines of systemic therapy.
The Harvard Drug Group, LLC, Issues Voluntary Nationwide Recall of Dronabinol Capsules, USP, 2.5 mg, and Ziprasidone Hydrochloride Capsules, 20 mg, Because of Label Mix-Up
On June 14, 2023, the U.S. Food and Drug Administration reported that the Harvard Drug Group, LLC, conducting business as Major Pharmaceuticals and Rugby Laboratories, issued a voluntary recall of a single lot of dronabinol capsules, USP, 2.5 mg, and ziprasidone hydrochloride capsules, 20 mg, after receiving a report that some unit dose cartons labeled as ziprasidone hydrochloride capsules, 20 mg, contained blister packages labeled as and containing dronabinol capsules, USP, 2.5 mg.
Oncology APRNs’ Role in Communicating With Older Adults With Cancer
Prepare for the silver tsunami—experts predict that the number of older adults with cancer, those aged 65 and older, will double by 2035. Oncology APRNs have a pivotal role in their care, understanding patients’ values and preferences to facilitate informed decision-making. But communication can be difficult when patients have comorbid geriatric syndromes such as cognitive deficits, delirium, and depression.
LGBTQ+ Patients With Cancer Need Education Tailored to Their Identity
More than two-thirds of patients who identify as LGBTQ+ lack at least one vital health education resource tailored to their identity, researchers reported in study findings presented at the 15th American Association for Cancer Research Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved. Additionally, nearly three-quarters of those patients desire posttreatment plans that include LGBTQ+ specific information.
Transform LGBTQ+ Cancer Care With These Evidence-Based Nursing Strategies
Less than 20% of National Cancer Institute Community Oncology Research Program practices routinely report collecting sexual orientation and gender identity data, limiting the available evidence to support recommendations for oncology nursing care of a vulnerable LGBTQ+ population that faces biases, stigma, cultural insensitivity, inequities, and disparities. In a 2022 Clinical Journal of Oncology Nursing article, ONS member Georgina T. Rodgers, BSN, RN, OCN®, NE-BC, and colleagues evaluated the latest studies to identify best practices and care considerations for LGBTQ+ patients with cancer.