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.
Disease Factors Influence Treatment Decisions More Than Comorbidities in Patients With Follicular Lymphoma
Data from U.S. Lymphocare suggest that older patients with follicular lymphoma (FL) are more commonly treated with watchful waiting or single-agent rituximab and found no difference in outcomes by treatment groups, but comorbidity was not studied. Researchers aimed to describe patient features, comorbidity use of positron-emission tomography (PET) staging, management choices, and the impact of polypharmacy on outcomes of patients with FL aged 70 years or older. Prathima Reddy, MD, at CHI Franciscan Hospital in Federal Way, WA, discussed the findings at the ASH Annual Meeting.
Study Assesses Ibrutinib’s Impact on Major Hemorrhage in Patients With B-Cell Malignancies
Ibrutinib is a first-in-class, once-daily inhibitor of Bruton tyrosine kinase that is approved for various B-cell malignancies. However, the drug is associated with increased rates of low-grade hemorrhage and sometimes serious hemorrhage, which is listed as a warning in the prescribing information. Patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and mantle cell lymphoma (MCL) are at an increased risk for major hemorrhage (MH) compared to the general population.
FDA Approves Obinutuzumab for Previously Untreated Follicular Lymphoma
On November 16, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to obinutuzumab (Gazyva®, Genentech, Inc.) in combination with chemotherapy, followed by obinutuzumab monotherapy in patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage II bulky, III, or IV follicular lymphoma (FL).
New Imaging Better Shows Immunotherapy Results in Brain Cancer
Researchers have developed a new approach for brain imaging that can better distinguish immune responses from tumor growth in people with glioblastoma. The findings were published in Proceedings of the National Academy of Sciences.
The Case of the Slow-to-Manifest Side Effects
Mary, age 60, has been diagnosed with stage IIB ovarian cancer. Because she has a strong family history of various cancers, Mary is tested for Lynch syndrome, also known as hereditary nonpolyposis colorectal cancer (HNPCC).
Her test is positive, and she is told she is at increased risk for developing cancers associated with HNPCC: ovarian, breast, prostate, kidney, endometrial, pancreatic, prostate, and liver.
FDA Approves Dasatinib for Pediatric Patients With CML
On November 9, 2017, U.S. the Food and Drug Administration (FDA) granted regular approval to dasatinib (Sprycel®, Bristol-Myers Squibb Co.) for the treatment of pediatric patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase.
FDA Approves Vemurafenib for Erdheim-Chester Disease
On November 6, 2017, the U.S. Food and Drug Administration granted regular approval to vemurafenib (Zelboraf®) for the treatment of patients with Erdheim-Chester Disease with BRAF V600 mutation.
Learn the Nursing Considerations for Cytokine Release Syndrome
Chimeric antigen receptor (CAR) T-cell therapy for relapsed or chemotherapy-resistant acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia, and B-cell lymphomas is becoming more common. The benefit to patients is significant: durable remission and increased comfort are two major advantages. However, severe toxicities are associated with CAR T-cell therapy that must be considered. As with any treatment modality, the best approach to management for an advanced practice oncology nurse is to fully understand those toxicities and be prepared to provide intensive supportive care.
FDA Grants Accelerated Approval to Acalabrutinib for Mantle Cell Lymphoma
On October 31, 2017, the Food and Drug Administration (FDA) granted accelerated approval to acalabrutinib (Calquence™, AstraZeneca Pharmaceuticals, Inc.) for treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy.
What Oncology Nurses Need to Know About Subcutaneous Rituxan Hycela
In June 2017, the U.S. Food and Drug Administration (FDA) approved Rituxan Hycela, a combination of rituximab and hyaluronidase, for subcutaneous administration in the treatment of follicular lymphoma and diffuse large B-cell lymphoma as well as chronic lymphocytic leukemia (CLL). This agent affords the same clinical benefit as IV rituximab, but in much less time. With this approval comes many questions about which patients are appropriate and administration considerations for subcutaneous rituximab and hyaluronidase.
FDA Update on Nerlynx™ (Neratinib) Tablets
On July 17, 2017, the U.S. Food and Drug Administration (FDA) approved Nerlynx™ (neratinib) tablets, an oral kinase inhibitor, for the extended adjuvant treatment of adult patients with early-stage human epidermal growth factor receptor 2-positive (HER2+) breast cancer, following adjuvant trastuzumab-based therapy.
FDA Approves Axicabtagene Ciloleucel for Large B-cell Lymphoma
On October 18, 2017, the Food and Drug Administration (FDA) granted regular approval to axicabtagene ciloleucel (Yescarta™) 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 (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
FDA Approves Abemaciclib For HR-Positive, HER2-Negative Breast Cancer
On September 28, 2017, the U.S. Food and Drug Administration approved abemaciclib in combination with fulvestrant for women with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.
FDA Grants Accelerated Approval to Nivolumab for HCC
On September 22, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab for the treatment of hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib.
FDA Grants Accelerated Approval to Pembrolizumab for Advanced Gastric Cancer
On September 22, 2017, the U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (Ketruda®) for patients with recurrent locally advanced or metastatic, gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 as determined by an FDA-approved test. Patients must have had disease progression on or after two or more prior systemic therapies, including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, HER2/neu-targeted therapy.