FDA Approves Selpercatinib for RET Fusion-Positive Non-Small Cell Lung Cancer and Locally Advanced or Metastatic Solid Tumors
On September 21, 2022, the U.S. Food and Drug Administration (FDA) granted regular approval to selpercatinib (Retevmo®) for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion and accelerated approval for adults with locally advanced or metastatic solid tumors with a RET gene fusion that progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.
FDA Approves Sodium Thiosulfate for Cisplatin-Associated Ototoxicity in Pediatric Patients
On September 20, 2022, the U.S. Food and Drug Administration (FDA) approved the use of sodium thiosulfate (Pedmark®) to reduce the risk of ototoxicity associated with cisplatin in pediatric patients aged 1 month and older with localized, nonmetastatic solid tumors.
Testicular Cancer Survivors May Need Fewer Monitoring Scans
Monitoring early-stage testicular cancer survivors for disease recurrence after surgery using either magnetic resonance imaging or fewer computed tomography scans is just as effective as more frequent intervals, researchers reported in study findings published in the Journal of Clinical Oncology.
Show Us Your Practice Through Our New Video Series
Do you have experience in educating your team on policies and procedures? How about a go-to nursing hack? Share your experiences and expertise through ONS Voice’s new video series, My Practice. Use this opportunity to connect with colleagues around the country and help us provide innovative ideas and solutions to nursing practice everywhere.
Baxter Healthcare Corporation Recalls Clearlink Basic Solution Set With Duovent Because of Leaks That Risk Exposure to Toxic Substances
On September 15, 2022, the U.S. Food and Drug Administration reported Baxter Healthcare Corporation’s recall of Clearlink basic solution set with Duovent because of reports of leaks. FDA identified it as a class I recall, the most serious type of recall, where use of the set may cause serious injuries or death.
Oncology Nurses’ Role in Translating Biomarker Testing Results
As oncology biomarker testing becomes a routine part of clinical practice, so does first-line use of their associated targeted therapies such as monoclonal antibodies, checkpoint inhibitors, and tyrosine kinase inhibitors.
FDA Reports Squamous Cell Carcinoma and Various Lymphomas in Capsule Around Breast Implants
On September 8, 2022, the U.S. Food and Drug Administration reported that cancers, including squamous cell carcinoma and various lymphomas, may develop in the capsule that forms around breast implants.
FDA Approves Durvalumab for Locally Advanced or Metastatic Biliary Tract Cancer
On September 2, 2022, the U.S. Food and Drug Administration approved durvalumab (Imfinzi®) in combination with gemcitabine and cisplatin for adult patients with locally advanced or metastatic biliary tract cancer.
FDA Approves Pemigatinib for Relapsed or Refractory Myeloid or Lymphoid Neoplasms With FGFR1 Rearrangement
On August 26, 2022, the U.S. Food and Drug Administration approved pemigatinib (Pemazyre®) for adults with relapsed or refractory myeloid or lymphoid neoplasms with fibroblast growth factor receptor 1 rearrangement.
FDA Approves Ibrutinib for Pediatric Patients With Chronic Graft-Versus-Host Disease, Including a New Oral Suspension
On August 24, 2022, the U.S. Food and Drug Administration approved ibrutinib (Imbruvica®) for pediatric patients aged less than 1 year with chronic graft-versus-host disease after failure of one or more lines of systemic therapy. Formulations include capsules, tablets, and oral suspension.
FDA Grants Accelerated Approval to Fam-Trastuzumab Deruxtecan-Nxki for HER2-Variant Non-Small Cell Lung Cancer
On August 11, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu®) for adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptor 2 (HER2) variants, as detected by an FDA-approved test, and who have received a prior systemic therapy. This is the first drug approved for HER2-variant NSCLC.
FDA Approves Capmatinib for Metastatic Non-Small Cell Lung Cancer
On August 10, 2022, the U.S. Food and Drug Administration (FDA) granted regular approval to capmatinib (Tabrecta®) for adult patients with metastatic non-small cell lung cancer whose tumors have a mutation leading to mesenchymal-epithelial transition exon 14 skipping, as detected by an FDA-approved test.
FDA Publishes Three New Biosimilars Resources for Healthcare Providers
To raise awareness and better educate patients and providers about biosimilars’ potential in clinical care, the U.S. Food and Drug Administration (FDA) added three new fact sheets to its healthcare provider resources in July 2022.
FDA Approves Darolutamide Tablets for Metastatic Hormone-Sensitive Prostate Cancer
On August 5, 2022, the U.S. Food and Drug Administration (FDA) approved darolutamide (Nubeqa®) tablets in combination with docetaxel for adult patients with metastatic hormone-sensitive prostate cancer.
FDA Approves Fam-Trastuzumab Deruxtecan-Nxki for HER2-Low Breast Cancer
On August 5, 2022, the U.S. Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki (Enhertu®) for use in adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH‑) breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.
Genetic Disorder Reference Sheet: Multiple Endocrine Neoplasia Type 2
Multiple endocrine neoplasia type 2 is an autosomal dominant disease that occurs because of germline pathogenic variants in the rearranged during transfection (RET) proto-oncogene. The RET gene was isolated in 1993 and pathogenic variants affect 1–10 per 100,000 people. Approximately 50% of cases are de novo.
Legislation and Cancer Care
Research and practice changes funded through healthcare legislation have influenced today’s care delivery across all settings: hospitals, clinics, and even homes. And with their constituents laser-focused on health in today’s pandemic society, legislators have never made that happen so quickly.
Oncology Drug Reference Sheet: Lutetium Lu 177 Vipivotide Tetraxetan
After clinical trial results demonstrated a four-month improvement in overall survival compared to best standard care, in March 2022 the U.S. Food and Drug Administration approved lutetium lu 177 vipivotide tetraxetan (PluvictoTM) to treat prostate-specific membrane antigen–expressing metastatic castration-resistant prostate cancer.
Smiths Medical Recalls Medfusion 3500 and 4000 Syringe Infusion Pumps for Software Malfunctions That Can Affect Infusion Delivery
On July 20, 2022, the U.S. Food and Drug Administration (FDA) reported Smiths Medical’s recall of its Medfusion 3500 and 4000 syringe infusion pumps because of software malfunctions. 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.
What the Evidence Says About Traditional Chinese Medicine for Chronic Diarrhea
Diarrhea is a distressing condition that significantly affects patients’ quality of life and social functioning. Characterized by passage of more than three unformed stools in 24 hours, in cancer it can be caused by chemotherapy, radiotherapy, laxatives and antibiotics, enteral feeding, malabsorption syndromes, colectomy, or several types of malignant tumors. Diarrhea has also been reported in long-term cancer survivors. Standard treatment options such as opiate agonists and adsorbents are associated with side effects that may increase a patient’s symptom burden.
Oncology Nursing QI Project Shows Normal Saline Is Comparable to Heparin for Pediatric CVCs
Emerging evidence has consistently shown that flushing central venous catheters with normal saline is comparable to heparin flushes in the adult care setting, leading to updated guideline recommendations that include saline as an alternative. But to date, only two studies have evaluated the two options in pediatric patients, the older of which found increased complications when used in children with leukemia or lymphoma. Is normal saline an acceptable alternative in that population?
FDA Warns About Risk of Death and Serious Side Effects With Duvelisib
On June 30, 2022, the U.S. Food and Drug Administration issued a drug safety communication for duvelisib (Copiktra®) after results from a clinical trial showed a possible increased risk of death associated with the agent, which is approved for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL who have received at least two prior therapies. The clinical trial results also associated duvelisib with a higher risk of serious side effects, including infections, diarrhea, lung and intestinal inflammation, skin reactions, and elevated liver enzymes.
Self-Affirmations Build Your Personal and Moral Resiliency
Positive phrases or statements that challenge negative or unhelpful thoughts can motivate you, encourage positive lifestyle changes, and boost your self-esteem. Repeat self-affirmation mantras regularly to fully reap the benefits of this practice and make long-term changes to the way you think and feel.
Healthcare Organizations Advocate for Clinical Trial Diversity in Letter to Congress
Healthcare organizations advocated to improve diversity among clinical trials in a letter sent to U.S. Congress in May encouraging the government to take steps as the reauthorization of the Prescription Drug User Fee Act (PDUFA) approaches. The PDUFA allows the U.S. Food and Drug Administration to review and approve drugs, but the authorization is set to expire in September of 2022.
Support Patients’ Autonomy and Cultural Choices
You are the oncology nurse caring for Maria, who has been diagnosed with non-small cell lung cancer (NSCLC). She says she doesn’t understand how she developed lung cancer because she has always lived a clean lifestyle according to her religious practices. You notice that although Maria is initially conversant with you, she allows her husband to speak for her whenever he is present. When you mention your observation to Maria, she tells you that in her religious culture, medical decisions are deferred to the high elders of the church.
FDA Says It’s Continuing to Evaluate Pulse Oximeters’ Race-Related Accuracy and Limitations
More than a year and a half after a report suggesting a potential racial bias in pulse oximeter technology first surfaced as a letter to the editor in the New England Journal of Medicine (NEJM), on June 21, 2022, the U.S. Food and Drug Administration (FDA) said that it is continuing its investigation into the devices’ accuracy and performance, particularly among people of color.
Oncology Drug Reference Sheet: Loncastuximab Tesirine-Lpyl
Based on LOTIS-2 trial results that reported an overall response rate of nearly 50%, in April 2021 the U.S. Food and Drug Administration granted accelerated approval to loncastuximab tesirine-lpyl (ZynlontaTM) for adults with relapsed or refractory large B-cell lymphoma.
The Case of the Late Head and Neck Lymphedema
Samuel, a 55-year-old patient with a history of T3N1M0 oropharyngeal HPV+ cancer on the base of his tongue, underwent surgery followed by 70 Gy of intensity-modulated radiation over seven weeks with concurrent weekly cisplatin. He responded well and had a positron emission tomography (PET) scan three months post-treatment that showed no cancer. Two months later, Samuel calls the triage line to report swelling on the left side of his neck, the same area where he first noticed a lymph node that led to his initial diagnosis.
Maintain Oral Adherence With ONS Guidelines™
With so many of today’s cancer treatments administered orally, ensuring that patients adhere to their regimen as prescribed is essential to optimal outcomes. According to the World Health Organization, medication adherence is the single most important modifiable factor that affects treatment outcomes.
Pediatric Patients With Cancer Are Vulnerable to Sleep Disturbance
Sleep disturbance has a significant impact on quality of life, including mental and physical health and academic, cognitive, and social functioning. It is one of the most common symptoms reported by pediatric patients with cancer and is significantly related to neurocognitive function for survivors.
FDA Reports Recall of Milk of Magnesia Oral Suspension and Magnesium Hydroxide/Aluminum Hydroxide/Simethicone Oral Suspension
On June 8, 2022, the U.S. Food and Drug Administration (FDA) reported Plastikon Healthcare's voluntarily recall of one lot of Milk of Magnesia 2,400 mg/10 ml oral suspension, one lot of Milk of Magnesia 2,400 mg/30 ml oral suspension, 11 lots of magnesium hydroxide 1,200 mg/aluminum hydroxide 1,200 mg/simethicone 120 mg per 30 ml oral suspension, and two lots of magnesium hydroxide 2,400 mg/aluminum hydroxide 2,400 mg/simethicone 240 mg per 30 ml oral suspension to the consumer level because of microbial contamination.
Independent Advocates Help Patients With Dementia Navigate Cancer Care
Clinicians have an implicit—if not explicit—obligation to advocate for their patients. However, as health care’s complexity increases, independent advocates can help patients navigate systematic challenges throughout the continuum. Independent advocates follow the patient, not the reimbursement constraints, a chief distinction between us and clinical, facility, or agency case managers.
Childhood Cancer Survivors Have Healthy but Riskier Pregnancies
Babies born to adult survivors of childhood cancers are as healthy as those born to adults without a history of cancer, but survivors have a higher risk of severe complications during pregnancy, researchers reported in the Journal of the National Cancer Institute.
FDA Reports Illumina Cybersecurity Vulnerability May Present Risks for Patient Results and Customer Networks
On June 2, 2022, the U.S. Food and Drug Administration (FDA) reported a cybersecurity vulnerability that affects software in the Illumina NextSeq 550Dx, MiSeqDx, NextSeq 500, NextSeq 550, MiSeq, iSeq, and MiniSeq next generation sequencing instruments. The devices are used in diagnostic (Dx), research-use only (RUO), or dual boot (either Dx or RUO) modes.
Connect With Your Patients on a Human Level as Well as a Healthcare Level
As a healthcare provider, I had been warned about getting too close to my patients. They told me that it was unprofessional, it would cloud my judgment, it would lead to emotional burnout, and various other reasons. For my first year as a nurse, I took that advice to heart and kept my emotional distance while still doing my best to provide care to the whole patient. Then one night I met Jeff, and everything changed.
FDA Withdraws Approval of Umbralisib Because of Safety Concerns
Because of safety concerns, the U.S. Food and Drug Administration (FDA) withdrew its approval of umbralisib (Ukoniq®) on June 1, 2022. Umbralisib had been approved to treat marginal zone lymphoma (MZL) and follicular lymphoma (FL).
FDA Approves Tisagenlecleucel for Relapsed or Refractory Follicular Lymphoma
On May 27, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tisagenlecleucel (Kymriah®) for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
FDA Approves Nivolumab in Combination With Chemotherapy and in Combination With Ipilimumab for First-Line Esophageal Squamous Cell Carcinoma Indications
On May 27, 2022, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo®) in combination with fluoropyrimidine- and platinum-based chemotherapy and nivolumab in combination with ipilimumab (Yervoy®) for the first-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC).
Rest, Unwind, and Reflect so You Can Lead by Example
Many nurses, even those in leadership, believe in the misconception that well-being is an indulgence or luxury they cannot afford, but this simply isn’t the case: it’s an investment that can improve your effectiveness, especially as a leader.
FDA Approves Ivosidenib in Combination With Azacitidine for Newly Diagnosed Acute Myeloid Leukemia
On May 25, 2022, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo®) in combination with azacitidine for patients with newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 variant as detected by an FDA-approved test in adults aged 75 years or older or those who have comorbidities that preclude use of intensive induction chemotherapy.
Mrs. Jones Gave Me the ‘Ah-Ha’ Moment That Guided My Entire Nursing Career
After years of hard work, Mrs. Jones and her husband had what seemed to be an idyllic life traveling and enjoying their life together. As a newly minted nurse on the medical/surgical unit, I got to know them over the months I cared for her during repeated admissions for melanoma. At each admission, they would be side by side, inseparable and so in love. I was just a new bride, and I wondered if my marriage would be as magical as theirs.
Oncology Drug Reference Sheet: Belumosudil
Chronic graft-versus-host disease (GVHD) is a severe adverse reaction after allogeneic hematopoietic cell transplantation that decreases quality of life and is a major cause of death. In July 2021, the U.S. Food and Drug Administration approved belumosudil (RezurockTM) as a third-line treatment option for chronic GVHD.
Use the Evidence to Integrate Ethics in Teleoncology Care
Emily manages a rural clinic associated with an academic cancer center. Patients initially have an in-person consultation with their treating oncologists at the main campus but then use telehealth for subsequent visits. To support patients during teleoncology visits, Emily wants to initiate a plan to collaborate with the clinic staff to identify and address the ethical principles for oncology care using telehealth.
Don’t Ask Patients About Their Symptoms—Have Them Tell You
“How are you doing?” We ask this question of our patients repeatedly: at diagnosis, during treatment, throughout survivorship, and at end of life. However, studies show that patients often give inaccurate answers to that direct question.
Studies Show Best Practices to Manage CAR T-Cell Therapies’ irAEs and Improve Outcomes
Rapid advancements in the science of chimeric antigen receptor (CAR) T-cell therapies present unique challenges and opportunities related to patient care. Nurses are at the forefront of those advancements—contributing to practice guidelines, developing center-specific protocols, publishing outcomes and best practices, and researching the patient experience, outcomes, and supportive interventions.
Oncology Clinical Social Workers Add Layers of Support for Patients and Families During CAR T-Cell Therapy
The interprofessional team for chimeric antigen receptor (CAR) T-cell therapy at Smilow Cancer Center at Yale New Haven includes a transplant team, cell collection and processing unit, intensive care unit, pharmacy, telehealth for home evaluations, and social work. On that team, the oncology clinical social worker’s role is chiefly to help patients and families manage the stress associated with therapy. We provide patients and family members with ongoing clinical social work support, including listening, counseling, educating, advocating, and referring them to resources and services.
CAR T-Cell Therapy Programs
Debuting in human clinical trials just a decade ago, chimeric antigen receptor (CAR) T-cell therapy was quickly hailed as a breakthrough cancer treatment for certain hematologic cancers. Today, patients and providers have access to 22 U.S. Food and Drug Administration (FDA)–approved cellular and gene therapy products, and CAR T-cell therapy is available beyond large academic research centers.
Targeting Beta2-Spectrin Could Prevent Biggest Contributor to Increasing HCC Rates
Excessive amounts of a protein called beta2-spectrin may put people at increased risk for nonalcoholic steatohepatitis (NASH), which is the leading cause of hepatocellular carcinoma (HCC), researchers said in a report published in Science Translational Medicine. Developing treatments to lower the protein may help reduce the incidence of both diseases.