FDA Simplifies IRB Requirements for Individual Patient Expanded Access
On October 3, 2017, the U.S. Food and Drug Administration (FDA) announced updates to three final guidance documents, including Form FDA 3926 and its instructions, to simplify Institutional Review Board (IRB) review requirements for physicians seeking to treat an individual patient with an investigational drug under expanded access. The updates allow for a waiver of the requirement for review and approval at a convened IRB meeting if the physician instead obtains concurrence by the IRB chairperson (or a designated IRB member) before treatment use begins.
Recent Drug Approvals Offer New Options for Non-Small Cell Lung Cancer, Genitourinary Cancers, and More
Cancer treatment options continue to multiply as 2017 continues, with the U.S. Food and Drug Administration (FDA) granting multiple new drug approvals and broadening indications for others. Oncology clinicians and nurses are challenged with staying abreast of treatment option expansions and navigating the dynamic field of cancer treatment to effectively navigate their patients through the treatment trajectory, educating on vital points relative to treatment, minimizing morbidity and mortality, and optimizing quality of life. Following is an overview of the latest approvals for the second quarter of 2017.
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 Approves Lower Dose of Cabazitaxel for Prostate Cancer
On September 14, 2017, the U.S. Food and Drug Administration (FDA) approved a lower dose of cabazitaxel (20 mg/m2 every 3 weeks) in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen. Cabazitaxel (25 mg/m2 every 3 weeks) was approved for this indication in 2010.
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.
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.
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.
Oncology Nurses Drive Change In Cancer Care With Clinical Trials
Clinical trials are responsible for discovering new treatments for cancer as well as the continued evolution of standards of care in clinical practice. Nationally, less than 5% of all eligible adult patients with cancer enroll in clinical trials. Additionally, it takes a drug an average of six to eight years from when it is first introduced in trials to become fully available to all patients who could benefit from it.
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 Tisagenlecleucel for B-cell ALL, Tocilizumab for Cytokine Release Syndrome
On August 30, 2017, the U.S. Food and Drug Administration granted regular approval to tisagenlecleucel for the treatment of patients up to age 25 years with B-cell precursor acute lymphoblastic leukemia that is refractory or in second or later relapse.
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.
Are Your Patients Taking Herbs That May Interact With Their Cancer Drugs?
Many Americans use dietary supplements, including herbal products, in the belief that they are natural and safe. Patients with cancer use them often to enhance the effects or to reduce the adverse reactions of cancer treatments. However, few herbs have been thoroughly studied in humans. Therefore, their interactions with prescription drugs and the clinical relevance, remain undetermined. These interactions could be pharmacokinetic in nature when an herb alters the absorption, metabolism, or excretion of other drugs, or pharmacodynamic in which it affects the mechanism of action of other drugs when consumed together. Following are a few relevant herb-drug interactions encountered in the oncology setting.
Ethnic Minority Patients May Receive Inferior End-of-Life Care
According to the results of a study published in the Journal of Clinical Oncology, African American and Hispanic patients with ovarian cancer who lived in Texas were more likely to receive invasive or toxic treatment and be admitted to intensive care in their final month of life than their Caucasian counterparts.
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.
FDA Approves Liposome-Encapsulated Combination of Daunorubicin-Cytarabine for Patients With AML
On August 3, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to a liposome-encapsulated combination of daunorubicin and cytarabine (Vyxeos™, Jazz Pharmaceuticals, Inc.) for the treatment of adults with newly-diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC), two types of AML having a poor prognosis.
Safely Provide Outpatient Care to Patients Receiving Hematopoietic Stem Cell Transplantations
High-dose chemotherapy with hematopoietic stem cell support is a well-established treatment for many hematologic malignancies. This treatment can be a difficult journey for patients and families. Historically, patients have been treated in a traditional hospital setting in anticipation of severe side effects, including mucositis, febrile neutropenia, thrombocytopenia, and pulmonary, renal, and hepatic complications. Patients can remain profoundly immunosuppressed for months while recovering from transplant. However, better supportive care in recent years has allowed many centers to move all or a portion of their transplant care into an outpatient setting.
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 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.
Managing VTE in Patients With Cancer
Venous thromboembolism (VTE) is a potentially life-threatening event characterized by clots that form in the veins, and it is the second-leading cause of death for patients diagnosed with cancer. VTE affects up to 10% of the cancer population, making it essential for oncology providers to understand the associated risk factors and preventative measures. In addition, prompt recognition and treatment for VTE becomes crucial to patient care.
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.
Using Standards Balances Technology Advancements With Critical Thinking
Advancements in medical records technology provide safeguards and contribute to overall patient safety. However, consider the following treatment scenarios and how they may present opportunities for error and jeopardize patient safety.
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.
Massage Has Therapeutic Value for Patients With Cancer
An ancient form of bodywork that encompasses hands-on manipulation of muscles and soft tissues, massage increases circulation, reduces muscular tension and promotes relaxation. It also produces emotional and psychological benefits.
Genomic Information Helps Guide Successful Therapies for Each Patient
The healthcare landscape is changing more rapidly than ever, and daily discoveries in genomics are leading to truly individualized care. During a session at the 42nd Annual Congress in Denver, CO, David Solit, MD, Geoffrey Beene Chair and director of the Marie-Josée and Henry R. Kravis Center for Molecular Oncology at Memorial Sloan Kettering Cancer Center (MSKCC), reviewed cutting-edge genomics science, its role in precision medicine, and innovative genomics programs at his institution. Solit leads a research program that seeks to identify new drug targets using genomic profiling.
Oncology Treatments and Trends Continue to Change Rapidly
“This has been a historic year in oncology pharmacology,” Rowena Schwartz, PharmD, BCOP, associate professor at the University of Cincinnati, told the audience during a session at the 42nd Annual Congress in Denver, CO. “There were new drugs, yes, but we’re really learning how to use the drugs that we have.”
Combination Drug Offers New Treatment Option for Relapsed Metastatic Colorectal Cancer
More than 130,000 new cases of colorectal cancers (CRCs) are diagnosed in the United States each year, representing 8% of all new annual cancer cases. The rate of patients with CRC surviving more than five years is 65.1%; however, patients with metastatic disease (mCRC) have a poorer prognosis, with only 13.5% surviving more than years. As many as 40% of patients with mCRC remain candidates for third-line therapy, with some patients requiring up to five lines of therapy because of drug resistance.
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.
How the Evolution of Immunotherapy Will Impact Oncology Nurses
Immunotherapy is one of the fastest-evolving areas of oncology to date. Previously, it could take years for some cancers to see new treatment options; today, the U.S. Food and Drug Administration is approving new immuno-oncology agents or new indications for those agents every few weeks. It’s a boon and a challenge to medical professionals. On the one hand, potentially life-changing treatments are making way to patients who need them—patients who have exhausted first-line treatments and now have limited options. On the other hand, healthcare professionals may struggle to stay current with the emerging trends, cutting-edge science, and evolving treatment plans for their patients.
FDA Grants Accelerated Approval to Pembrolizumab for First Tissue/Site Agnostic Indication
On May 23, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda®, Merck & Co.) for adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options or with MSI-H or dMMR colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
What Special Considerations Are Needed When Setting up IV Chemotherapy?
No solid research exists regarding IV chemotherapy administration setups, because they can vary greatly based on the regimen, equipment availability, and patient status. Of the utmost importance is that the administration setup ensures chemotherapy is given safely and allows for prompt nursing intervention in the event of an adverse reaction or infiltration.
The Case of the Immunotherapy Inquiry
Jay is a 62-year-old man with newly diagnosed, stage IIIA (T3, N1), unresectable, non-small cell lung cancer (NSCLC) that tested negative for ALK, EGFR, and KRAS mutations. Additionally, PD-L1 (programed death receptor ligand) expression was less than 30%. Jay is symptomatic with a persistent cough, unintentional weight loss, and fatigue.
What Oncology Nurses Need to Know About Immunotherapy Agents
As immunotherapeutic options for cancer treatments continue to grow, oncology nurses need a deeper understanding of the therapies, how they work, and how to manage their side effects, so they can continue to provide the best patient care.