FDA Grants Accelerated Approval to Sacituzumab Govitecan for Advanced Urothelial Cancer
On April 13, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to sacituzumab govitecan (Trodelvy®) for patients with locally advanced or metastatic urothelial cancer who previously received a platinum-containing chemotherapy and either a programmed death receptor-1 or a programmed death-ligand 1 inhibitor.
Nursing Management of Adverse Events From Enfortumab Vedotin Therapy for Urothelial Cancer
Once patients stop responding to platinum-based chemotherapy for locally advanced or metastatic urothelial cancer, their treatment options had been somewhat limited: PD-1/PD-L1 inhibitors were effective in only 13%–29% of patients and taxanes in only 11%–13%. When the antibody drug conjugate enfortumab vedotin was approved in late 2019, it offered new hope for patients and providers, with clinical trials reporting a 44% objective response rate.
Involve the Entire Cancer Care Team to Effectively Implement Guidelines
Only 19% of strategies to implement clinical practice guidelines are fully effective and the majority (43%) are not effective at all, according to the findings from a clinical review in the European Union. Effective guideline implementation requires teamwork, interprofessional engagement, and selecting the most appropriate tool for the job.
The Case of the Targeted Therapy Toxicity
Tyrone is a 74-year-old man with a history of acute myeloid leukemia (AML), type 2 diabetes, and hypertension who was admitted to the hospital after lab results revealed 40% circulating blasts in his peripheral blood that was concerning for relapsed disease. He was diagnosed with AML three years ago and achieved remission after treatment with a hypomethylating agent.
Nursing Considerations for Head and Neck Cancer Survivorship Care
Despite accounting for only 3% of all cancer survivors, patients with head and neck cancers often require significant support and survivorship care. And oncology nurses can expect survivorship to grow with recent improvements in prognosis and treatment options, such as with reductions in human papillomavirus-related oropharyngeal cancers, which tend to affect young people and offer improved long-term survival rates.
FDA Approves Sacituzumab Govitecan for Triple-Negative Breast Cancer
On April 7, 2021, the U.S. Food and Drug Administration (FDA) granted regular approval to sacituzumab govitecan (Trodelvy®) for patients with unresectable locally advanced or metastatic triple-negative breast cancer who received two or more prior systemic therapies, at least one of which for metastatic disease.
FDA Approves New Cetuximab Dosing Regimen for Colorectal Cancer and Squamous Cell Carcinoma
On April 6, 2021, the U.S. Food and Drug Administration (FDA) approved a new dosage regimen for cetuximab (Erbitux®) of 500 mg/m2 via IV infusion for 120 minutes every two weeks for patients with KRAS wild-type, epidermal growth factor receptor-expressing colorectal cancer or squamous cell carcinoma of the head and neck.
FDA Issues Safety Communication for ADM Products Used in Implant-Based Breast Reconstruction
On March 31, 2021, the U.S. Food and Drug Administration (FDA) issued a safety communication informing patients, caregivers, and healthcare providers that certain acellular dermal matrix (ADM) products used in implant-based breast reconstruction may have a higher chance for complications or problems.
FDA Approves Isatuximab-Irfc for Multiple Myeloma
On March 31, 2021, the U.S. Food and Drug Administration (FDA) approved isatuximab-irfc (Sarclisa®) in combination with carfilzomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.
FDA Approves Idecabtagene Vicleucel as the First Cell-Based Gene Therapy for Adult Patients With Multiple Myeloma
On March 27, 2021, the U.S. Food and Drug Administration (FDA) approved idecabtagene vicleucel (Abecma), for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. This is the first FDA-approved cell-based gene therapy for multiple myeloma.
Zydus Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Acyclovir Sodium Injection
On March 25, 2021, the U.S. Food and Drug Administration shared Zydus Pharmaceuticals Inc.’s notice of its voluntary recall of four lots of acyclovir sodium injection 50 mg/ml, supplied in 10 ml and 20 ml vials, after receiving reports of crystallization in the product.
The Case of the Cord Blood Match
Zhang is a 67-year-old man who had no history of medical concerns until he was hospitalized for pneumonia. A complete blood count taken during his workup for pneumonia showed pancytopenia, and a biopsy confirmed a diagnosis of acute myeloid leukemia. After multiple rounds of induction therapy, Zhang's bone marrow biopsy showed minimal residual disease and he entered remission. His oncologist recommends an allogeneic hematopoietic stem cell transplant as soon as possible because of the disease's aggressive nature, but he has no match in the registry.
Infection Prevention for Oncology Nurses
Regardless of care setting, oncology nurses must be vigilant about creating a safe environment for and educating patients about the importance of infection prevention. Patients with cancer are at increased risk for viral, bacterial, and fungal infections, but the extent depends on cancer type and treatment.
Genetic Disorder Reference Sheet: CHEK2 Gene Pathogenic Variants
The CHEK2 (checkpoint kinase 2) tumor suppressor gene provides cells with instructions for making a protein known as CHK2, which becomes active when the cell’s DNA is damaged or strands of it break. CHEK2 halts cell division and enables either cell repair or destruction. Without a properly functioning CHEK2 gene, cells lose a key restraint on their growth which may lead to uncontrolled cells and possibly malignancy. CHEK2*1100delC is the most common pathogenic variant and most prevalent in European populations.
FDA Approves Pembrolizumab for Esophageal or GEJ Carcinoma
On March 22, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda®) for use in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal junction (GEJ) (tumors with an epicenter 1–5 cm above the gastroesophageal junction) carcinoma who are not candidates for surgical resection or definitive chemoradiation.
FDA Advises Healthcare Professionals Not to Use BD’s ChloraPrep™ 3 ml Applicators
On March 19, 2021, the U.S. Food and Drug Administration (FDA) issued an advisory to healthcare professionals not to use ChloraPrep 3 ml applicators manufactured by BD (Becton, Dickinson and Company) because of the risk of microbial contamination. The product was distributed globally and is labeled with “CareFusion, El Paso, TX.”
Management Strategies for Cutaneous Toxicity From EGFR Inhibitors
Epidermal growth factor receptor (EGFR)-targeted therapy is effective for several solid tumor malignancies, primarily non-small cell lung cancer with EGFR mutation and metastatic colorectal cancer. Although the agents spare patients from typical side effects seen with more conventional cytotoxic chemotherapies, such as nausea or vomiting, they do have a unique side-effect profile, including potentially dose-limiting cutaneous toxicity.
FDA Approves Tivozanib for Relapsed or Refractory Advanced Renal Cell Carcinoma
On March 10, 2021, the U.S. Food and Drug Administration (FDA) approved tivozanib (Fotivda®), a kinase inhibitor, for adult patients with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies. FDA approved the application three weeks ahead of its goal date.
FDA Grants Accelerated Approval to Axicabtagene Ciloleucel for Relapsed or Refractory Follicular Lymphoma
On March 5, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to axicabtagene ciloleucel (Yescarta®) for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
FDA Approves Lorlatinib for ALK-Positive Metastatic NSCLC
On March 3, 2021, the U.S. Food and Drug Administration (FDA) granted regular approval to lorlatinib (Lorbrena®) for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive, as detected by an FDA-approved test. FDA also approved the Ventana ALK (D5F3) CDx Assay as a companion diagnostic for lorlatinib.
Nursing Considerations for Colorectal Cancer Survivorship Care
As the third most common cancer among both men and women, colorectal cancer is a reality for the more than 1 million people in the United States who are living with or have a history of the disease. Advancements in early detection and treatment have improved outcomes, but many survivors experience late and long-term side effects that may vary in duration, intensity, and impact on their quality of life. Clinicians must tailor each survivorship care plan for a patient’s cancer type, stage, treatment received, psychosocial implications, and side effects or toxicities. Studies have shown that experiencing long-term side effects and symptoms can reduce survivors’ quality of life.
FDA Grants Accelerated Approval to Melphalan Flufenamide for Relapsed or Refractory Multiple Myeloma
On February 26, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to melphalan flufenamide (Pepaxto®) in combination with dexamethasone for adults with relapsed or refractory multiple myeloma who received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD-38–directed monoclonal antibody.
Self-Care Is Essential When Working Remotely
Did you ever imagine that you could do your job remotely? I did not, but that’s what I’m doing right now. Working remotely has become the new normal for certain professional roles, including some in nursing. An estimated 31% of new hires since March 2020 work from home. In February 2020, the Centers for Disease Control and Prevention released social distancing guidelines and recommended the use of telehealth for patient visits. In March 2020, telehealth visits increased 154% compared to March 2019. Working at home has affected both healthcare workers and patients.
FDA Approves Cemiplimab-Rwlc for NSCLC With High PD-L1 Expression
On February 22, 2021, the U.S. Food and Drug Administration (FDA) approved cemiplimab-rwlc (Libtayo®) for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation and whose tumors have high PD-L1 expression (tumor proportion score ≥ 50%) as determined by an FDA-approved test, with no estimated aberrations to glomerular filtration rate, anaplastic lymphoma kinase, or receptor tyrosine kinase (encoded by the ROS1 gene).
Be Alert for Axillary Adenopathy After COVID-19 Vaccination
Nearly 60 million people in the United States and almost 200 million around the world have received the COVID-19 coronavirus vaccine as of mid-February 2021, and the numbers will continue to grow as more doses come to market and other manufacturers’ versions receive emergency use authorizations. As more people get vaccinated, some of the expected side effects are being observed in clinical practice and have implications for cancer care.
FDA Approves Trilaciclib to Reduce Chemotherapy-Induced Myelosuppression
On February 12, 2021, the U.S. Food and Drug Administration (FDA) approved trilaciclib (Cosela™) as the first therapy in its class to reduce the frequency of chemotherapy-induced myelosuppression in adults receiving certain types of chemotherapy for extensive-stage small cell lung cancer. Trilaciclib inhibits cyclin-dependent kinase 4/6 (CDK 4/6) enzymes to prevent bone marrow damage.
Inclusion in National Repository Helps Move ONS Guidelines™ Evidence to Practice
When they launched in 2020, oncology nurses recognized the first five ONS Guidelines™ for cancer treatment-related symptoms and adverse events as the evidence-based standard for patient care. Now, the ECRI Guidelines Trust, a national evaluation organization, has given them that distinction as well, including all of ONS’s current guidelines in its repository.
FDA Approves Cemiplimab-Rwlc for Locally Advanced and Metastatic Basal Cell Carcinoma
On February 9, 2021, the U.S. Food and Drug Administration (FDA) approved cemiplimab-rwlc (Libtayo®) for use in patients with locally advanced basal cell carcinoma previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate. FDA also granted accelerated approval to cemiplimab-rwlc for patients with metastatic BCC previously treated with an HHI or for whom an HHI is not appropriate.
FDA Approves Lisocabtagene Maraleucel for Relapsed or Refractory Large B-Cell Lymphoma
On February 5, 2021, the U.S. Food and Drug Administration (FDA) approved lisocabtagene maraleucel (Breyanzi®) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified—including DLBCL arising from indolent lymphoma—high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.
Nursing Considerations for Lymphoma Survivorship Care
As treatments have advanced and patients and providers have more options, cure and survivorship rates for lymphomas are improving: five-year survival rates for Hodgkin and non-Hodgkin lymphoma are 86% and 71%, respectively. Despite good results from treatment, research indicates that lymphoma survivors carry a significant amount of late and chronic effects. Even in a complete remission, late effects of treatment present a burden for patients' physical and psychosocial well-being.
FDA Grants Accelerated Approval to Tepotinib for Metastatic NSCLC
On February 3, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tepotinib (Tepmetko®) for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition exon 14 skipping alterations.
Oncology Drug Reference Sheet: Tafasitamab-Cxix
Tafasitamab-cxix (Monjuvi®) received accelerated approval from the U.S. Food and Drug Administration in July 2020 in combination with lenalidomide for adults with relapsed or refractory diffuse large B-cell lymphoma.
Genetic Disorder Reference Sheet: Lynch Syndrome (Hereditary Nonpolyposis Colorectal Cancer)
Lynch syndrome, now referred to as hereditary nonpolyposis colorectal cancer (HNPCC), was first identified in a family in 1895. In 1966, Henry Lynch reported a series of families with colon and other cancers in the Nebraska area. Today, the evidence shows that HNPCC is associated with germline pathogenic variants in the MLH1, MSH2, MSH6, PMS2, and EPCAM genes.
FDA Approves Nivolumab Plus Cabozantinib for Advanced Renal Cell Carcinoma
On January 22, 2021, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo®) in combination with cabozantinib (Cabometyx®) as first-line treatment for patients with advanced renal cell carcinoma.
The Case of the Targeted Therapy Toxicities
Three years ago, Tony, a 42-year-old man, began FOLFOX chemotherapy treatment for stage III colon cancer and achieved a complete response. Two years later, a biopsy of an intraabdominal lesion uncovered metastatic disease, and he was prescribed the epidermal growth factor inhibitor (EGFRi) cetuximab. Alex, the oncology nurse educating Tony on the side effects of EGFRi therapy, understands that skin toxicities are common with the class of drugs and looks for national guidelines for prevention and management direction.
FDA Approves Crizotinib for Children and Young Adults With Relapsed or Refractory, Systemic ALK-Positive Anaplastic Large Cell Lymphoma
On January 14, 2021, the U.S. Food and Drug Administration (FDA) approved crizotinib (Xalkori®) for pediatric patients aged one year or older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK) positive. The safety and efficacy of crizotinib have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL.
Sunstar Americas, Inc., Expands Voluntary Nationwide Recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12%, for Microbial Contamination
On December 28, 2020, the U.S. Food and Drug Administration announced that Sunstar Americas, Inc., expanded its October 27, 2020, voluntary recall of Paroex® chlorhexidine gluconate oral Rinse USP, 0.12%, because of possible contaminated with the bacteria Burkholderia lata.
Oncology Drug Reference Sheet: Alpelisib
When used in combination with fulvestrant, alpelisib (Piqray®) produced complete or partial responses in 29% of patients with PIK3CA-altered, estrogen receptor-positive advanced breast cancer in clinical trials. The U.S. Food and Drug Administration approved it for use in 2019.
The Case of the Virtual Venture
Staff in an oncology infusion unit located in an urban healthcare system watched as patient and caregiver stress increased during the COVID-19 coronavirus pandemic and the November 2020 U.S. presidential elections. During a team meeting, Holly, one of the nurses, brought up a study she read about that used virtual reality (VR) as a distraction for patients undergoing chemotherapy. The staff was interested in implementing a similar program at their institution but wasn’t sure how to start. What would you do?
FDA Approves Pralsetinib for RET-Altered Thyroid Cancers
On December 1, 2020, the U.S. Food and Drug Administration (FDA) approved pralsetinib for patients aged 12 years and older with advanced or metastatic RET-mutant medullary thyroid cancer who require systemic therapy or RET fusion-positive therapy and who are refractory to radioactive iodine (if radioactive iodine is appropriate).
Harnessing the Power of Genes
Since the mapping of the human genome in 2003, genetic testing has rapidly evolved from single-gene tests to more complex profiles that measure multiple genes; it’s now part of standard care for many cancer types. Precision oncology allows clinicians to take patient-specific genomic factors into consideration when making treatment decisions, which can lead to improved outcomes, lower overall cost, and fewer side effects.
FDA Grants Accelerated Approval to Naxitamab for High-Risk Neuroblastoma in Bone or Bone Marrow
On November 25, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to naxitamab (Danyelza®) in combination with granulocyte-macrophage colony-stimulating factor for pediatric patients one year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who demonstrate a partial response, minor response, or stable disease to prior therapy.
Oncology Drug Reference Sheet: Selpercatinib
In May 2020, the U.S. Food and Drug Administration gave accelerated approval for selpercatinib (Retevmo®) to treat RET-altered non-small cell lung cancer or thyroid cancer based on overall response rate and duration of response. Selpercatinib fights cancer by impeding RET protein activity. The determining clinical trial results demonstrated that it reduced tumor size in more than 50% of patients and was associated with fewer adverse reactions than other drugs that block the RET protein.
COVID-19 Drug Reference Sheet: Bamlanivimab
On November 9, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization for bamlanivimab, an unapproved agent, to treat mild to moderate cases of the COVID-19 coronavirus. EUAs are not FDA approval. Bamlanivimab’s initial supply is limited, but the manufacturer announced increased production and distribution in early 2021.
Aspirin’s Cancer Benefits May Not Translate to Older Adults
Healthy older adults who take daily low-dose aspirin have increased risk of being diagnosed with advanced cancers and dying from cancer, according to findings from a new study published in the Journal of the National Cancer Institute.
The Case of the Chronic Cancer Condition
Lisa, a 32-year-old tax accountant, completed treatment for stage III triple-negative breast cancer 18 months ago. During a follow-up appointment, Lisa reported worsening headaches and difficulty concentrating at work. A magnetic resonance imaging scan and subsequent biopsy revealed a solitary brain lesion. She completed stereotactic brain radiation two months ago.
FDA Grants Accelerated Approval to Pembrolizumab for Locally Recurrent Unresectable or Metastatic TNBC
On November 13, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple negative breast cancer (TNBC) whose tumors express PD-L1 (combined positive score [CPS] ≥ 10) as determined by an FDA-approved test. FDA also approved the PD-L1 IHC 22C3 pharmDx as a companion diagnostic for selecting patients with TNBC for pembrolizumab.