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.
FDA Approves Olutasidenib for Relapsed or Refractory Acute Myeloid Leukemia With Susceptible IDH1 Variants
On December 1, 2022, the U.S. Food and Drug Administration approved olutasidenib (Rezlidhia®) capsules for adult patients with relapsed or refractory acute myeloid leukemia with susceptible IDH1 variants as detected by an FDA-approved test. FDA also approved the Abbott RealTime IDH1 Assay to identify patients who are appropriate for olutasidenib.
Genetic Disorder Reference Sheet: HOXB13
An altered HOXB13 gene may increase a patient’s risk for developing prostate cancer. The HOXB13 gene is expressed in the prostate beginning in early development and affects prostate cell proliferation and differentiation and androgen receptor regulation. When it acts as a tumor suppressor gene, HOXB13 codes for a protein that regulates cell division. However, altered copies of HOXB13 are inactivated, meaning that it does not function properly or does not produce the protein it codes for, resulting in uncontrolled cell division.
Help Your Patients Prepare for the End From the Beginning
Few things carry more stigma in the United States than death and hospice. Death is familiar in oncology, yet providers may not discuss it with patients until their cancer has progressed to the point that medical intervention is no longer an option. With the American Cancer Society estimating more than 600,000 American deaths from cancer in 2022, it’s time to change our practice.
FDA Approves Second Dosing Regimen for Asparaginase Erwinia Chrysanthemi (Recombinant)-Rywn
On November 18, 2022, the U.S. Food and Drug Administration approved a Monday-Wednesday-Friday dosing option for asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze®). Under the alternative regimen, patients receive 25 mg/m2 intramuscularly on Monday and Wednesday mornings and 50 mg/m2 intramuscularly on Friday afternoons. It also is approved at a dose of 25 mg/m2 intramuscularly every 48 hours.
Oncology Drug Reference Sheet: Tebentafusp-Tebn
When the U.S. Food and Drug Administration approved tebentafusp-tebn (Kimmtrak®) in January 2022 as an orphan drug for unresectable or metastatic uveal melanoma in adults, it became the first—and only, at the time of this reference sheet’s publication—drug approved for the indication.
Monica Bertagnolli Delivers First NCI Director’s Report, Outlines Principles to Evolve Cancer Research
In her first report as National Cancer Institute director, Monica M. Bertagnolli, MD, laid out her eight core principles to guide the agency’s work in reformulating clinical trials and strengthening cancer research during the Clinical Trials Advisory Committee meeting in November 2022.
FDA Approves Brentuximab Vedotin in Combination With Chemotherapy for Pediatric Patients With Classical Hodgkin Lymphoma
On November 10, 2022, the U.S. Food and Drug Administration (FDA) approved brentuximab vedotin (Adcetris®) plus doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide for pediatric patients aged two years and older with previously untreated, high-risk classical Hodgkin lymphoma. This is the first pediatric approval for brentuximab vedotin.
FDA Grants Accelerated Approval to Mirvetuximab Soravtansine-Gynx for FR Alpha–Positive, Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
On November 14, 2022, the U.S. Food and Drug Administration granted accelerated approval to mirvetuximab soravtansine-gynx (Elahere®) for adult patients with folate receptor alpha–positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, as detected with an FDA-approved test, who received one to three prior systemic treatment regimens. Mirvetuximab soravtansine-gynx is a FR alpha–directed antibody and microtubule inhibitor conjugate. FDA also approved the VENTANA FOLR1 (FOLR-2.1) RxDx Assay (Ventana Medical Systems, Inc.) as a companion diagnostic device to identify patients for the indication.
What the Evidence Says About Probiotics and Cancer Immunotherapy
Growing evidence suggests that the gut microbiome, a diverse and complex mix of microorganisms and their metabolites, is closely linked to the immune system, and researchers are studying whether modulating the gut microbiome affects cancer immunotherapy treatment outcomes. In particular, probiotics—which are flora typically obtained through dietary sources such as yogurt and fermented foods or via supplemental forms—are gaining prominence as a potential strategy to modulate the gut microbiome during cancer treatment.
PARP Inhibitors and Ovarian Cancer
Before poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitors were approved for ovarian cancer, traditional treatment consisted of surgical cytoreduction and platinum-based chemotherapy with a taxane, with or without bevacizumab, depending on stage and type. With the surgery-chemotherapy combination, 70%–75% of patients had recurrence and overall five-year survival rates were 29%, indicating a need for additional therapies.
Educational Resources Will Help Biomarkers Have Even More Impact
My passion for biomarkers lies in research, specifically clinical trials. The incorporation of biomarkers in oncology clinical trials has been an important advancement in research, and we’ve seen the effect on improving patient outcomes. Identification of pathogenic variants is essential to prescribing personalized therapy for patients with cancer.
Predictive and Diagnostic Biomarkers
Biomarkers, also called molecular markers or signature molecules, can help clinicians characterize alterations in tumors through the detection of specific DNA, RNA, protein, or metabolomic profiles. These pieces of the cancer puzzle are part of precision oncology that the cancer care team can use to assess patients’ cancer risk and prognosis or monitor disease progression. Biomarkers are also a key factor in determining and tailoring treatment methods and their likelihood of success.
NCI Awards $23 Million to Establish Centers to Study Telehealth for Cancer Care
Four academic institutions will create centers of excellence dedicated to telehealth in cancer care to help healthcare providers increase its use in oncology practice, thanks to $23 million in National Cancer Institute (NCI) funding. The awards are part of NCI’s Telehealth Research Centers of Excellence initiative, which is supported by President Joe Biden’s Cancer Moonshot initiative.
FDA Recommends Reusing Tracheostomy Tubes or Switching to Appropriate Alternatives Because of Shortage
On October 31, 2022, the U.S. Food and Drug Administration alerted patients, caregivers, and healthcare providers of a tracheostomy tube shortage, including Bivona tracheostomy tubes manufactured by ICU Medical, because of difficulty obtaining required raw materials. FDA said it is working with manufacturers and other stakeholders to help resolve supply challenges and support the devices’ availability.
FDA Recommends Healthcare Providers Consider Alternatives for MRI-Guided Breast Biopsy Grid Plates Because of Shortage
On October 31, 2022, the U.S. Food and Drug Administration recommended that healthcare providers discuss alternative options for magnetic resonance imaging–guided breast biopsy procedures with patients if a facility is unable to perform it because of a shortage of Philips Invivo MRI breast biopsy grid plates and other Philips Invivo MRI disposables.
Genetic Counselors Help Patients and Oncology Nurses Predict Current and Future Cancer Diagnoses
Many of our patients are individuals who haven’t developed cancer but might have a concerning family history of the disease. We rely on healthcare providers like oncology nurses to identify individuals with concerning cancer histories and refer them to genetic counselors for a complete risk assessment, including genetic testing when appropriate, to determine their risk and recommend proactive measures to reduce it.
FDA Approves Teclistamab-Cqyv for Relapsed or Refractory Multiple Myeloma
On October 25, 2022, the U.S. Food and Drug Administration granted accelerated approval to teclistamab-cqyv (Tecvayli®), the first bispecific B-cell maturation antigen–directed CD3 T-cell engager, for adult patients 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 Tremelimumab in Combination With Durvalumab for Unresectable Hepatocellular Carcinoma
On October 21, 2022, the U.S. Food and Drug Administration approved tremelimumab (Imjudo®) in combination with durvalumab for adult patients with unresectable hepatocellular carcinoma.
Oncology Drug Reference Sheet: Asparaginase Erwinia Chrysanthemi (Recombinant)–Rywn
After more than 93% of patients maintained nadir serum asparaginase activity in the therapy’s clinical trials, on June 30, 2021, the U.S. Food and Drug Administration approved asparaginase erwinia chrysanthemi (recombinant)–rywn (RylazeTM) for use as a component of a multiagent chemotherapeutic regimen for treatment of acute lymphoblastic leukemia and lymphoblastic lymphoma in adult and pediatric patients who have developed hypersensitivity to E. coli-derived asparaginase.