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.
Dendritic Cell Vaccine Uses Immune System to Fight NSCLC
A new study testing a dendritic cell vaccine for the first time in humans to treat non-small cell lung cancer (NSCLC) has shown that it successfully amplifies the immune system to boost the effectiveness of anti-PD-1 immunotherapies against the cancer. The findings were published in Clinical Cancer Research.
FDA Grants Accelerated Approval to Copanlisib for Relapsed Follicular Lymphoma
On September 14, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to copanlisib for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies.
Manage Adverse Events From Immunotherapy and Targeted Therapy for Melanoma
New targeted and immunotherapy drug approvals have offered improved survival and disease outcomes for patients with melanoma, but the new therapies are also associated with a range of adverse events (AEs) that differ from those associated with chemotherapy. Oncology nurses will need to shift their thinking to best manage those AEs.
FDA Approves Gemtuzumab Ozogamicin for CD33-Positive AML
On September 1, 2017, the U.S. Food and Drug Administration (FDA) approved gemtuzumab ozogamicin (Mylotarg, Pfizer Inc.) for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and for treatment of relapsed or refractory CD33-positive AML in adults and in pediatric patients 2 years and older. Gemtuzumab ozogamicin may be used in combination with daunorubicin and cytarabine for adults with newly-diagnosed AML, or as a stand-alone treatment for certain adult and pediatric patients.
FDA Halts Two Clinical Trials Evaluating Pembrolizumab in Patients With Multiple Myeloma
On August 31, 2017, based on data from two recently halted clinical trials, the U.S. Food and Drug Administration (FDA) is issuing a statement to inform the public, healthcare professionals, and oncology clinical investigators about the risks associated with the use of Keytruda (pembrolizumab) in combination with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) for the treatment of patients with multiple myeloma. Keytruda (pembrolizumab) is not approved for treatment of multiple myeloma.
FDA Approves Olaparib Tablets for Maintenance Treatment in Ovarian Cancer
On August 17, 2017, the U.S. Food and Drug Administration granted regular approval to olaparib tablets for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy.
FDA Approves Inotuzumab Ozogamicin for Relapsed, Refractory B-Cell Precursor ALL
On Aug. 17, 2017, the U.S. Food and Drug Administration approved inotuzumab ozogamicin for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
FDA Expands Ibrutinib Indications to Chronic GVHD
On August 2, 2017, the U.S. Food and Drug Administration (FDA) approved ibrutinib (Imbruvica®, Pharmacyclics LLC) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy. This is the first FDA-approved therapy for the treatment of cGVHD.
FDA Approves Enasidenib for Adults With Relapsed or Refractory AML With an IDH2 Mutation
On August 1, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to enasidenib for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.
The Importance of HPV Vaccination for Your Patients
August marks the beginning of National Immunization Awareness Month, which is an annual observance to promote awareness of the importance of vaccination for individuals of all ages. It’s a great time for nurses to check with their patients and make sure they’re up to date on the recommended vaccines.
FDA Grants Nivolumab Accelerated Approval for Colorectal Cancer
On July 31, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab for the treatment of patients 12 years and older with mismatch repair deficient and microsatellite instability high metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
Management of Immunotherapy-Related Endocrinopathies
Advanced practice oncology nurses know how complex the care of patients with cancer can be. Every day seems to bring further advancements in the treatment and management of cancer. It can be difficult to keep up with the onslaught of new information, but our patients rely on us to bring them the latest, greatest, and safest treatment options available.
Patient-Provider Communication on Immunotherapy Can Be Improved
Guidelines regarding healthcare provider communication about immunotherapy do not currently exist. Researchers sought to determine patient and provider preferences for this type of information and to identify barriers to communication about immunotherapy. The study’s findings were presented at the 2017 ASCO Annual Meeting.
The Case of the Immunotherapy Inquiry, Part II
You may remember Jay, a 62-year-old man with inoperable stage IIIA non-small cell lung cancer (NSCLC), from the case study in the April 2017 issue of ONS Voice. He was symptomatic with a persistent cough, unintentional weight loss, and fatigue.
FDA Approves First Single NGS Test to Detect Multiple RAS Mutations
On June 29, 2017, the U.S. Food and Drug Administration (FDA) granted marketing approval to the Praxis Extended RAS Panel (Illumina, Inc.), a next generation sequencing (NGS) test to detect certain genetic mutations in RAS genes in tumor samples of patients with metastatic colorectal cancer (mCRC). The test is used to aid in the identification of patients who may be eligible for treatment with panitumumab (Vectibix®, Amgen, Inc.).
What Safe Handling and Administration Requirements Apply to Immunotherapy?
In a supplement to the April 2017 issue of the Clinical Journal of Oncology Nursing, ONS released its first set of recommendations for nurse education and safe handling principles regarding immunotherapy administration. ONS recommendations are based on best-available evidence and the anecdotal experiences of professionals at cancer centers with varied experiences in immunotherapy administration.
FDA Approves Dabrafenib and Trametinib Combination for Metastatic NSCLC with BRAF V600E Mutation
On June 22, 2017, the U.S. Food and Drug Administration granted (FDA) regular approvals to dabrafenib and trametinib (Taflinar® and Mekinist®, Novartis Pharmaceuticals Inc.) administered in combination for patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test.
FDA Approves Rituximab Plus Hyaluronidase Combination for Treatment of FL, DLBCL, and CLL
On June 22, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to the combination of rituximab and hyaluronidase human (Rituxan Hycela, Genentech Inc.) for adult patients with follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia.
Combination Treatment Improves Survival for Advanced Melanoma
A combination of nivolumab and ipilimumab improved overall survival when compared to either drug alone, according to results from a recent study reported at the American Association for Cancer Research 2017 annual meeting.
Recent FDA Approvals Continue to Focus on Targeted and Immunotherapy
Oncology clinicians can expect to continue to see new targeted and immunotherapy drugs emerge as clinically approved agents in the fight against cancer. Five cancer-related U.S. Food and Drug Administration (FDA) approvals occurred in the first quarter of 2017; following are their indications for treatment and associated clinical implications. You’ll recognize that some of the agents were already FDA approved for other uses, but as clinical trials continue and new data emerge, clinical use is expanding to other disease sites and indications.
Members Meet to Lead ONS Into the Future
As Oncology Nursing Month, May saw celebrations at the ONS 42nd Annual Congress and in our workplaces. Nurses on ONS staff enjoyed recognition and celebration of their commitment to our mission and you. They partner closely with members who volunteer their time and expertise in developing initiatives and priorities for ONS. I would like to describe a few of those initiatives and work groups that have met at the national office in the first six months of 2017.
Cultivate Your Immunotherapy Education With ONS Resources
Cancer centers across the country, especially those in larger medical centers, are seeing many immunotherapy agents in standard care now. Patients are hearing about advancements in immunotherapies, they’re excited by the possibilities, and the U.S. Food and Drug Administration is approving new drugs or indications almost every month. Although many patients still don’t recognize the distinction between standard treatment options and immunotherapy, it’s vital for nurses to stay educated and understand how these treatments work differently from traditional care options.