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.
FDA Approves Fam-Trastuzumab Deruxtecan-Dxki for HER2-Positive Gastric Adenocarcinomas
On January 15, 2021, the U.S. Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki (Enhertu®) for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.
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.
Genomics Provides Insight on Exceptionally Responding Patients
Patients with cancer who experience unexpected and long-lasting treatment outcomes are considered exceptional responders, but researchers and clinicians had no insight as to why the patients did so well with treatment. Results of a new study now show that genomic characterizations of cancer can uncover genetic alterations that may contribute to the phenomenon, researchers reported in Cancer Cell.
Adding Nivolumab to Chemo Improves Survival for Advanced Gastric Cancer
First-line therapy combining nivolumab with chemotherapy improved median overall survival rates in patients with PD-L1-expressing gastric cancer by 3.3 months in a large international, multicenter trial. The findings were reported during the 2020 European Society for Medical Oncology virtual meeting.
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.
Genomics May Trick PARP Inhibitors to Treat More Cancers
Turning on the body’s inflammasome with epigenetic therapy may improve the efficacy of PARP inhibitors across multiple tumor types, possibly expanding the therapy’s application to new cancers, researchers reported in Proceedings of the National Academy of Sciences.
FDA Approves Selinexor for Relapsed or Refectory Multiple Myeloma
On December 18, 2020, the U.S. Food and Drug Administration (FDA) approved selinexor (Xpovio®) in combination with bortezomib and dexamethasone for the treatment of adult patients with relapsed or refectory multiple myeloma who have received at least one prior therapy.
FDA Approves Relugolix for Advanced Prostate Cancer
On December 18, 2020, the U.S. Food and Drug Administration (FDA) approved the first oral gonadotropin-releasing hormone receptor antagonist, relugolix, (Orgovyx™) for adult patients with advanced prostate cancer.
FDA Approves Margetuximab-cmkb for Metastatic HER2-Positive Breast Cancer
On December 16, 2020, the U.S. Food and Drug Administration (FDA) approved margetuximab-cmkb (Margenza™) in combination with chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who previously received two or more anti-HER2 regimens, at least one of which was for metastatic disease.
Pancreatic Cancer Risk Factors, Diagnosis, Treatment, Side Effects, and Survivorship Considerations
Pancreatic cancer is the ninth most common cancer in the United States, accounting for 3% of all cancers but causing 7% of cancer-related deaths, which equates to about 57,500 diagnoses and 47,050 deaths each year. The average person’s risk for pancreatic cancer is about 1 in 64.
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).
NKT Cells May Be the Next Wave of CAR Therapy
When genetically modified with a chimeric antigen receptor (CAR), natural killer T (NKT) cells eliminated 50% of metastases in a patient with heavily pretreated, relapsed or refractory metastatic neuroblastoma, according to interim findings from an ongoing study that were published in Nature Medicine.
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.
The Evolving Landscape of Cell Transplant Therapy in Cancer Care
Each year more than 50,000 stem cell transplantations are completed worldwide. The stimulation, harvesting, and therapeutic use of patient and donor cells has evolved as a treatment for diverse cancer diagnoses, and specially trained nurses are at the heart of the clinical trials and care delivery to propel cell transplant therapy across practice settings.
It’s Time to Take a New Look at Radiation Therapy
Radiation therapy (RT) has been used as a safe and effective treatment option for patients with cancer for more than a century. Like any cancer therapy, it does carry risks and side effects, but RT has improved drastically over the past 20 years and has even been shown to enhance the effectiveness of immunotherapy.
New Treatments in Radiation Oncology
Included in the treatment plan for approximately 50% of all patients with cancer, radiotherapy (RT) is a significant component of cancer care. RT is a technology-driven oncology modality, which means it has continually evolved since being introduced in cancer care in the early 20th century.
FDA Approves Nivolumab and Ipilimumab for Malignant Pleural Mesothelioma
On October 2, 2020, the U.S. Food and Drug Administration (FDA) approved nivolumab in combination with ipilimumab for the first-line treatment of adults with malignant pleural mesothelioma that cannot be removed by surgery. This is the first drug regimen approved for mesothelioma in 16 years and the second FDA-approved systemic therapy for mesothelioma.
Non-Hodgkin Lymphoma Symptoms, Diagnosis, Treatment, and Survivorship Recommendations
Lymphomas are hematologic malignancies, specifically of the lymphatic system. They are classified into two types: Hodgkin and non-Hodgkin (NHL). NHL is the seventh most common cancer in the United States and Hodgkin seen much less frequently as the 26th, but new treatment options have improved survival rates.
Blocking Fatty Acid Storage May Induce Glioblastoma Apoptosis
Turning off an enzyme that glioblastoma cells use to store the fatty acids they feed on as energy for rapid cell division may offer a new treatment option for the deadly cancer, researchers reported in Cell Metabolism.
FDA Rejects Atezolizumab in Combination With Paclitaxel as Treatment for Breast Cancer
On September 8, 2020, the U.S. Food and Drug Administration (FDA) announced it did not approve atezolizumab (Tecentriq®) in combination with paclitaxel for treatment of breast cancer after a clinical trial studying the use of atezolizumab and paclitaxel in patients with previously untreated inoperable locally advanced or metastatic triple negative breast cancer (mTNBC) showed the drug combination did not work to treat the disease.
Oncology Drug Reference Sheet: Rucaparib
Rucaparib (Rubraca®) has U.S. Food and Drug Administration approval for both maintenance and treatment indications in gynecologic cancers. It originally received accelerated approval in 2016 for the treatment of deleterious, BRCA variant–associated advanced ovarian cancer that has failed two or more chemotherapies. In 2018, it was approved for maintenance therapy of various gynecologic malignancies. Most recently, rucaparib received approval for BRCA-positive metastatic castration-resistant prostate cancer treatment after androgen-directed and chemotherapy.
Oncology Drug Reference Sheet: Enfortumab Vedotin-Ejfv
Enfortumab vedotin-ejfv (Padcev™) was granted accelerated approval in December 2019 for adults with locally advanced or metastatic urothelial cancer who previously received an immune checkpoint inhibitor (PD-1 or PD-L1 inhibitor) and platinum-containing therapy.
Myeloproliferative Neoplasm Symptoms, Diagnosis, Treatment, and Survivorship Recommendations
Myeloproliferative neoplasms are a group of blood cancers that start with a small mutation in the stem cells of the bone marrow. Although MPNs are quite rare, essential thrombocythemia, polycythemia vera, and myelofibrosis are the most common types. Each represents a mutation of a different source of stem cell.
Help Patients Understand Genomic Variants of Unknown Significance
Patients approach genetic testing, either for germline (inherited) or somatic (tumor) alterations, hoping it will provide valuable information about their cancer risk, prognosis, or treatment options. Next-generation sequencing makes it possible to test for panels of 40 or more genes simultaneously. By testing more genes, the possibility of finding an actionable, informative result improves, but so does the chance of having a result with one or more variants of unknown clinical significance.
FDA Approves Nivolumab for Esophageal Squamous Cell Carcinoma
On June 10, 2020, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo®) for patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.
Investigational Maintenance Therapy Extends Survival in AML
A new drug is extending both remission and survival in adults with acute myeloid leukemia (AML), according to findings reported at the American Society of Hematology annual meeting in December 2019. The study was funded by Celgene, the drug’s manufacturer.
Nurses Address Barriers to Care Through CoC’s Revised Standards
Many factors can affect the way patients access their care. But one thing is certain: if patients don’t get the care they need, their chances for success decline. To address barriers to cancer care, the American College of Surgeons’ Commission on Cancer (CoC) outlined specific, measurable actions that institutions must take.
Harnessing the Abscopal Effect May Change Cancer Care
The abscopal effect is a unique phenomenon in cancer treatment that occurs when radiation shrinks untreated tumors found elsewhere in the body in addition to the targeted tumor. The effect has a long history, dating back to the 1950s, but it doesn’t commonly occur in practice and the mechanisms are not fully understood. Research has shown that combining immunotherapy with radiation increases the rate at which the abscopal effect occurs. Understanding how it appears in practice could potentially lead to new cancer treatments and a novel approach to combining immunotherapies with radiation.
Immunotherapies have revolutionized the approach to cancer treatment by leveraging patients’ own immune systems to fight the disease. But the novel therapies have also brought an evolution in traditional treatment regimens through their combination with chemotherapy, radiation, targeted therapy, or even other immunotherapy drugs.
FDA Approves Daratumumab and Hyaluronidase-Fihj for Multiple Myeloma
On May 1, 2020, the U.S. Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro™) for adult patients with newly diagnosed or relapsed or refractory multiple myeloma. The product allows for subcutaneous dosing of daratumumab.
Oncology Drug Reference Sheet: Daratumumab
Daratumumab (Darzalex®) was originally approved by the U.S. Food and Drug Administration in 2015 with additional indications added since. The most recent new indication was approved in September 2019 for newly diagnosed patients with multiple myeloma who are eligible for autologous stem cell transplantation. In May 2020, daratumumab and hyaluronidase-fihj (Darzalex Faspro™), a subcutaneous (SQ) formulation, was approved.
Oral and Oropharyngeal Cancer Prevention, Screening, Treatment, and Survivorship Recommendations
Approximately 53,000 cases of oral and oropharyngeal cancer are diagnosed in the United States each year. Men are twice as likely to develop the disease, and it typically affects people older than 55.
New Treatments Show Promise for Metastatic HER2-Positive Breast Cancer
Two new drugs in clinical trials are extending survival for women with metastatic HER2-positive breast cancer that had progressed with previous treatment. One of the drugs was effective for brain metastasis, which is particularly difficult to treat. Results from both studies were reported in the New England Journal of Medicine.
Oncology Drug Reference Sheet: Tocilizumab
Tocilizumab was approved in August 2017 for the treatment of chimeric antigen receptor T cell–induced cytokine release syndrome. In March 2020, the U.S. Food and Drug Administration approved a randomized, double-blind, placebo-controlled, phase III clinical trial to assess the safety and efficacy of tocilizumab plus standard of care in patients hospitalized with severe COVID-19 pneumonia.
The Case of the Cryotherapy Consequences
Janice is 32 years old and was recently diagnosed with triple-negative breast cancer. She is receiving neoadjuvant chemotherapy with doxorubicin and cyclophosphamide, followed by weekly paclitaxel. Janice is a nationally recognized performer (vocal and piano) and is distraught over the possibility of losing her hair or developing chemotherapy-induced peripheral neuropathy and mouth sores. She asks the nurse what can be done to prevent those unwanted side effects.
Pembrolizumab Is More Cost Effective Than Atezolizumab for NSCLC
Adding atezolizumab to treatment with bevacizumab, carboplatin, and paclitaxel as first-line therapy for metastatic, nonsquamous non-small cell lung cancer (NSCLC) is associated with survival benefit—but it comes at a cost, researchers said in study results published in JAMA Network Open. In comparison, pembrolizumab offers a more cost-effective survival benefit.
Colorectal Cancer Prevention, Screening, Treatment, and Survivorship Recommendations
Colorectal cancer (CRC) is the third most common cancer affecting men and women in the United States. When CRC is found at an early stage before it has spread, the five-year relative survival rate is about 90%, yet it remains a leading cause of cancer-related death among both genders.
Staffing Levels in Ambulatory Oncology Nursing
Convenience. Flexibility. Normalcy. Ambulatory oncology clinics deliver on those three crucially important aspects of treatment to many patients with cancer, offering expert care without a hospital stay or traveling far from home.
ONS Members Help Drive the Ambulatory Staffing Discussion
With evolving treatments and novel approaches to care, outpatient oncology practice has grown exponentially during the past two decades. As a vital stop on the cancer journey for many patients, ambulatory clinics have seen a boom in acuity, patient needs, and staffing demands. ONS has been actively researching the growing staffing dilemma in ambulatory oncology nursing to help institutions understand and address nurse-patient staffing and which best practices can accommodate the varied challenges.
BRAF Mutations Guide Treatment in Metastatic Colorectal Cancer
Molecular profiling has become essential for the treatment of metastatic colorectal cancer (CRC) when surgery cannot be considered and systemic therapy is recommended. CRC has several potential mutations that are diagnostic, prognostic, and predictive. National Comprehensive Cancer Network (NCCN) guidelines recommend that advanced practice providers conduct RAS, BRAF, HER2, and MSI testing as part of a full molecular panel, review the results, and acted on them prior to starting patients on systemic therapy.
FDA Grants Regular Approval to Cabometyx for First-Line Treatment of Advanced Renal Cell Carcinoma
On December 19, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to cabozantinib for treatment of patients with advanced renal cell carcinoma (RCC).
Address the Challenge of Polypharmacy in Older Adults Undergoing Cancer Treatment
Polypharmacy is the use of several medications simultaneously for different medical conditions. Data confirm that polypharmacy is prevalent in older adults with cancer, with one study reporting a minimum of four prescriptions to define polypharmacy. Many medications prescribed during cancer care are intended to treat other comorbid conditions that occur prior to a patient’s cancer diagnosis (e.g., heart disease, hypertension, hyperlipidemia, reflux disease). Reportedly, one third of individuals older than 65 years use more than one pharmacy to fill prescription medications. This can lead to further confusion for patients regarding medication management.
FDA Approves First Biosimilar for Cancer Treatment
On September 14, 2017, the U.S. Food and Drug Administration (FDA) approved Mvasi (bevacizumab-awwb, Amgen Inc.) as a biosimilar to Avastin (bevacizumab, Genentech Inc.). Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer.
Senate Passes Bill to Focus on Childhood Cancer Treatments
A new bill passed in the U.S. Senate last week will provide measures to ensure that drug companies are developing treatments for children with cancer. The RACE for Children Act is part of the U.S. Food and Drug Administration (FDA) Reauthorization Act of 2017, which aims to speed up the approval process for new treatments and medical devices and is expected to be signed into law by President Trump.