FDA Approves Pembrolizumab for Adjuvant Treatment of Melanoma
On February 15, 2019, the U.S. Food and Drug Administration (FDA) approved pembrolizumab for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.
Survival Gains Make CAR T-Cell Therapy Cost-Effective for Pediatric Leukemia
When evaluated based on the cost per life-year gained, the chimeric antigen receptor (CAR) T-cell immunotherapy drug tisgenlecleucel is considered cost effective in pediatric B-cell acute lymphoblastic leukemia, researchers reported in a new study. The findings were published in JAMA Pediatrics.
Cancer Moonshot Moves to Research Phase
Still a popular program throughout the government, the , encourage collaboration in finding treatments and cures, and to improve data sharing to make a decade’s progress in half the time. Through NIH’s Moonshot Blue Ribbon Panel and the 2016 passage of the 21st Century Cures Act—allocating $1.8 billion over seven years for Moonshot—the initiative is moving out of planning and into the research phase.
Take a Closer Look at Immune Checkpoint Inhibitors
One way that cancer has been able to evade the immune system is through overexpression of immune checkpoint proteins (immune inhibitory pathway), which allow cancer cells to be considered “self” instead of foreign and block T-cell action. Immune checkpoint proteins cytotoxic T-lymphocyte–associated 4 (CTLA-4) and programmed cell death protein (PD-1) are receptors that are expressed on the surface of cytotoxic T cells. Immune checkpoint inhibitors prevent those receptors from binding to their natural ligands, disrupting the immune inhibitory pathway. See Table 1 for a list of approved agents and indications.
Majority of Real-World Patients With DLBCL Are Eligible for CAR T-Cell Therapy
Patients with diffuse large B-cell lymphoma (DLBCL) often experience long-term survival after initial anthracycline-containing therapy; however, relapse leads to poor outcomes. Some patients with relapsed or refractory disease may receive additional chemoimmunotherapy followed by hematopoietic cell transplantation (HCT), but as many as 50% of patients cannot undergo HCT because of lack of response to chemoimmunotherapy or comorbidities. Chimeric antigen receptor (CAR) T-cell therapy may be an option for those patients, but real-world data on CAR T-cell therapy for DLBCL are limited.
CBT May Improve Response to Subsequent Treatment in Heavily Pretreated Patients With HL
Patients with relapsed or refractory Hodgkin lymphoma (HL) after checkpoint blockade therapy (CBT) have limited options. However, researchers found that CBT may impact response to subsequent therapies. Nicole A. Carreau, MD, of New York University Langone Health in New York City, discussed the findings at the ASH Annual Meeting on December 1, 2018.
FDA Approves Brentuximab Vedotin for Previously Untreated sALCL and CD30-Expressing PTCL
On November 16, 2018, the U.S. Food and Drug Administration (FDA) approved brentuximab vedotin in combination with chemotherapy for previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified. This is the first FDA approval for previously untreated PTCL including sALCL.
FDA Grants Accelerated Approval to Pembrolizumab for Hepatocellular Carcinoma
On November 9, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for patients with hepatocellular carcinoma who have been previously treated with sorafenib.
An Oncology Nursing Overview of Biosimilars
Since the first biosimilar agent was approved by the U.S. Food and Drug Administration (FDA) in 2015, patients and providers have had concerns about the implications for their care and practice, respectively. Because 6 of the 12 biosimilar drugs currently approved in the United States have indications for oncology practice, oncology nurses have a responsibility to understand the drugs’ safety and efficacy for the patients in their care.
Educational Approach Improves Oncology Advanced Providers’ Knowledge and Experience With Immunotherapy
As more immunotherapies come to market, advanced practitioners need to know how to prescribe and recognize, triage, and manage immune-related adverse events (irAEs) as well as champion education about the agents’ benefits and risks.
Priming Lines With Drug May Reduce Hypersensitivity Reactions From Rituximab
Monoclonal antibody cancer treatments such as rituximab have a high risk for hypersensitivity reactions from cytokine release syndrome. The symptoms, which can range from mild to life threatening, result from tumor antigen-expressing cells releasing cytokines (e.g., tumor necrosis factor, interleukin, interferon) into the blood as they are destroyed. Symptoms include fever, chills, rigors, rash, headache, hypotension, shortness of breath, bronchospasm, nausea, vomiting, and abdominal pain.
Ketogenic Diet May Overcome Drug Resistance With PI3K Inhibitors
Researchers have shown in mouse models that using PI3K inhibitor targeted therapy along with a ketogenic diet may help prevent or overcome the drug resistance that can eventually occur. The findings were reported in Nature.
Older Patients Respond Better to Checkpoint Inhibitors for Melanoma
Patients aged 62 and older are more likely to respond to immune checkpoint inhibitors for melanoma, such as pembrolizumab, according to findings from a study published in Clinical Cancer Research. A follow-up study showed that it may be because of age-related changes in the immune cells in melanoma tumors.
FDA Grants Approval for Pembrolizumab in Combination With Chemotherapy for First-Line Treatment of Metastatic Nonsquamous NSCLC
On August 20, 2018, the U.S. Food and Drug Administration (FDA) approved pembrolizumab in combination with pemetrexed and platinum as first-line treatment of patients with metastatic, non-squamous non-small cell lung cancer, with no EGFR or ALK genomic tumor aberrations.
FDA Grants Nivolumab Accelerated Approval for Third-Line Treatment of Metastatic SCLC
On August 16, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab for patients with metastatic small cell lung cancer (SCLC) with progression after platinum-based chemotherapy and at least one other line of therapy.
FDA Approves Mogamulizumab-kpkc for Mycosis Fungoides or Sézary Syndrome
On August 8, 2018, the U.S. Food and Drug Administration (FDA) approved mogamulizumab-kpkc (Poteligeo) for adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy.
Men May Have Greater Survival Benefit From Immune Checkpoint Inhibitors
Researchers have found a significant difference in overall survival in men versus women receiving immune checkpoint inhibitors for advanced cancers. The findings from the systematic review and meta-analysis were reported in Lancet Oncology.
Using CTCAE to Report Immunotherapy Adverse Events
Although immunotherapy is changing the face of cancer care, it’s not exempt from side effects. As researchers and clinicians work to understand immune-related adverse events and how to manage them, a new challenge is emerging: reporting and grading them to get an accurate grasp on incidence rates and to standardize care to ensure better outcomes for patients. The Common Terminology Criteria for Adverse Events (CTCAE) is one tool that’s helping researchers and bedside nurses do just that.
The Oncology Nurse Experience in Managing Adverse Events in Patients Receiving Ibrutinib
Ibrutinib is a first-in-class Bruton’s tyrosine kinase inhibitor that is approved by the U.S. Food and Drug Administration to treat chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). The drug’s approval was based on results from the multicenter, open-label, phase III RESONATE trial.
Nurse Management of cGVHD in Patients on Ibrutinib Focuses on Education
Ibrutinib is a first-in-class, once-daily inhibitor of Bruton’s tyrosine kinase. In 2017, the U.S. Food and Drug Administration approved ibrutinib for the treatment of adult patients with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy.
Instructional Class Improves CAR T-Cell Knowledge in ICU and BMT Nurses
Chimeric antigen receptor T-cell (CAR T-cell) therapy has become an integral part of the advancement of lymphoma and other cancer treatments. However, educational resources and available published literature are still lacking for oncology and intensive care nurses.
FDA Grants Accelerated Approval to Ipilimumab for Certain Metastatic Colorectal Cancers
On July 10, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to ipilimumab for use in combination with nivolumab for the treatment of patients 12 years of age and older with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
FDA Approves Encorafenib and Binimetinib in Combination for Unresectable or Metastatic Melanoma With BRAF Mutations
On June 27, 2018, the U.S. Food and Drug Administration (FDA) approved encorafenib and binimetinib (Braftovi and Mektovi) in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.
Boosting T-Cell Memory Enhances Immunotherapy Effectiveness
A combination of immunotherapies may increase the formation of memory T cells and lead to a more lasting response, according to findings from a study presented at the American Association for Cancer Research’s 2018 annual meeting.
The Case of the CTCAE Assessment for CDK4/6 Adverse Events
Mrs. Jones is a 66-year-old postmenopausal woman who developed left breast pain and a palpable mass. A mammogram and ultrasound showed a 4.6 cm mass with an enlarged axillary node. A core biopsy revealed invasive ductal carcinoma that is estrogen receptor positive, progesterone receptor positive, and HER2 negative. Positron-emission tomography and computed tomography scans revealed metastatic disease.
Immunotherapy Plus Chemo Improves Survival in Metastatic Lung Cancer
Combining pembrolizumab and platinum chemotherapy plus pemetrexed doubles survival in patients with nonsquamous non-small cell lung cancer (NSNSCLC) without EGFR or ALK gene mutations, according to the results of a study published in the New England Journal of Medicine.
Here’s an Overview of the Types, Mechanisms, and Side Effects of Currently Approved Immunotherapies
Immunotherapy drugs fall into varying classes, each carrying its own mechanism of action and anticipated side effects. Although some side effects of immunotherapy may appear similar to those of chemotherapy (e.g., diarrhea, fatigue), they actually result from a totally different mechanism—meaning they require a different approach to management. Treating immunotherapy side effects as you would chemotherapy effects would likely result in patient harm.
Pharmacology Update Session Gives Oncology Nurses the Essentials on New Drug Approvals
If it seems like a new oncology drug or indication comes to market every month, you wouldn’t be wrong. The U.S. Food and Drug Administration (FDA) has approved a record number of oncology agents in 2017 and 2018. Teresa Knoop, MSN, RN, AOCN®, assistant director of clinical operations at the Clinical Trials Shared Resource at Vanderbilt-Ingram Cancer Center in Nashville, TN, gave an update on the latest therapies during a session at the 43rd Annual Congress in Washington, DC.
Managing Immunotherapy-Related Adverse Events
Immunotherapy is becoming an important role in cancer care and having an understanding of immune-related adverse events (irAEs) is critical for oncology nurses to provide safe and effective patient care. Rowena Schwartz, PharmD, BCOP, of the University of Cincinnati in Ohio, discussed strategies for managing these AEs during a session at the 43rd Annual Congress in Washington, DC.
Immunotherapy Opens New Frontiers in Lung Cancer Care
The development of targeted therapies brought new progress to lung cancer treatment and research in the past 20 years, and new options will continue to be available in the future. Roy Herbst, MD, PhD, director of thoracic oncology research program at the Yale Comprehensive Cancer Center at Yale School of Medicine in New Haven, CT, spoke at the 43rd Annual Congress in Washington, DC, on new standards of care for non-small cell lung cancer (NSCLC), immunotherapy for NSCLC, and development of rational drug combinations using biomarkers.
FDA Reports Efficacy Issue for Patients Taking Pembrolizumab or Atezolizumab as Monotherapy to Treat Urothelial Cancer with Low Expression of PD-L1
The U.S. Food and Drug Administration (FDA) is alerting healthcare professionals, oncology clinical investigators, and the public about decreased survival associated with the use of pembrolizumab (Keytruda) or atezolizumab (Tecentriq) as monotherapy in clinical trials to treat patients with metastatic urothelial cancer who have not received prior therapy and who have low expression of the protein programmed death ligand 1 (PD-L1).
Follow These Nursing Best Practices in Managing Patients Receiving CAR T-Cell Therapy
Kathleen McDermott, RN, BSN, OCN®, BMTCN®, of the Dana-Farber Cancer Institute, and coauthors presented the background for axicabtagene ciloleucel’s approval and nursing best practices for managing patients receiving CAR T-cell therapy during a poster session at the ONS 43rd Annual Congress in Washington, DC.
Stay Current on Evolving Therapies in Melanoma
After decades of no new treatment options for advanced melanoma, several drugs for unresectable stage III and IV disease and recurrent melanoma have been approved, including newer classes of drugs such as checkpoint inhibitors (anti-PD-1 and anti-CTLA-4 drugs) and signal transduction inhibitors (BRAF, MEK, and KIT inhibitors). Advanced practice registered nurses (APRNs) must be familiar with these newer agents and classes of drugs, especially the mutations that guide their use.
FDA Approves Dabrafenib Plus Trametinib for Adjuvant Treatment of Melanoma With BRAF V600E or V600K Mutations
On April 30, 2018, the U.S. Food and Drug Administration (FDA) granted regular approval to dabrafenib (Tafinlar ®) and trametinib (Mekinist®) in combination for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection.
Biosimilars Offer New Options for Treatment and New Concepts for Patient Education
The list of pharmacologic agents used in cancer care is expanding: chemotherapy, biotherapy, immunotherapy, targeted therapy, hormonal therapy, and now biosimilars. Part of being a nurse leader is recognizing trends in cancer care, changes on the horizon, and their impact on your patients and cancer treatment options. Biosimilars represent one such trend that affects providers’ approach to care and the education that oncology nurses must provide to patients and caregivers.
The Case of the Checkpoint Inhibitor Side Effects
John is a 62-year-old man diagnosed with metastatic non-small cell lung cancer (NSCLC). His tumor tested positive for high PD-L1 expression, and he began pembrolizumab treatment. John presents to the clinic for his third treatment and mentions that during the past week his arms and chest have been itchy and he has noticed a red, bumpy rash on his chest. When assessing John’s skin, you note a maculopapular rash on both of his upper extremities, anterior chest, and upper abdomen. What would you do?
FDA Approves Nivolumab Plus Ipilimumab Combination for Renal Cell Carcinoma
On April 16, 2018, the U.S. Food and Drug Administration (FDA) granted approvals to nivolumab and ipilimumab in combination for the treatment of intermediate or poor risk, previously untreated advanced renal cell carcinoma.
FDA Approves Rucaparib for Treatment of Recurrent Ovarian Cancer
On April 6, 2018, the U.S. Food and Drug Administration (FDA) approved rucaparib, a poly ADP-ribose polymerase inhibitor, for the maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
Cancer and Immunotherapy Organizations Release Checkpoint Inhibitor Side Effect Guidelines
New guidelines and consensus recommendations for managing immune-related adverse events (irAEs) from checkpoint inhibitors are available from several key cancer and immunotherapy organizations: a collaboration between the American Society of Clinical Oncology and National Comprehensive Cancer Network, and a separate consensus recommendation from the Society for Immunotherapy of Cancer. ONS contributed to the development of both sets of guidelines.
FDA Grants Accelerated Approval to Blinatumomab for B-Cell Precursor ALL
On March 29, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to blinatumomab (Blincyto®) for the treatment of adult and pediatric patients with B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.
ONS Members Help Define Checkpoint Inhibitor Adverse Event Guidelines
Because the treatment of symptoms, side effects, and adverse events associated with immunotherapies can differ greatly from the standard of care, the American Society of Clinical Oncology (ASCO) and National Comprehensive Cancer Network (NCCN)—along with experts from ONS staff and membership—collaborated to develop guidelines to inform clinicians about managing immune-related adverse events associated with checkpoint inhibitor therapy.
FDA Approves Nivolumab Dosing Update
On March 6, 2018, the U.S. Food and Drug Administration (FDA) approved updated dosing information for nivolumab (Opdivo®). Nivolumab is now the first FDA-approved PD-1 inhibitor that offers a flexible dosing option of every two weeks at 240 mg or every four weeks at 480 mg for most approved indications.
Immunotherapy Without Immune Cells May Be on the Horizon
Researchers have generated immunotherapy in the laboratory using nonimmune cells. If the findings can be translated into treatment, it may reduce some of the immune-related adverse events that patients experience with today’s cancer immunotherapy treatments. The study was reported in Nature Chemical Biology.
FDA Approves Olaparib for Germline BRCA-Mutated Metastatic Breast Cancer
On January 12, 2018, the U.S. Food and Drug Administration (FDA) granted regular approval to olaparib tablets, a poly (ADP-ribose) polymerase (PARP) inhibitor, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer who have been treated with chemotherapy either in the neoadjuvant, adjuvant, or metastatic setting.
FDA Approves First Biosimilar for Cancer Treatment, Among Other New Immunotherapy Dosing and Indications
Cancer treatment options continue to multiply as 2017 concludes, with the U.S. Food and Drug Administration (FDA) granting additional new drug approvals and broadening indications for others. Checkpoint inhibitors continue to explode on the scene with accelerated approvals for various indications. Treatment options for hematologic cancers are multiplying. Additionally, the first biosimilar for cancer treatment, bevacizumab-awwb, was approved as a biosimilar to bevacizumab.
Real-World Findings for Ibrutinib in Patients With CLL: Toxicities, Discontinuations, and More
Ibrutinib is approved by the U.S. Food and Drug Administration (FDA) for the treatment of chronic lymphocytic leukemia (CLL). Researchers sought to study real-world outcomes related to adverse events (AEs), treatment discontinuation, outcomes, and subsequent therapies in those treated with frontline ibrutinib. Anthony R. Mato, MD, at the University of Pennsylvania Abramson Cancer Center in Philadelphia, PA, discussed the findings at the ASH Annual Meeting.