FDA Grants Accelerated Approval to Zanubrutinib for Mantle Cell Lymphoma
On November 14, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to zanubrutinib (Brukinsa™) for adult patients with mantle cell lymphoma who have received at least one prior therapy.
FDA Approves Niraparib for HRD-Positive Advanced Ovarian Cancer
On October 23, 2019, the U.S. Food and Drug Administration (FDA) approved niraparib (Zejula®) for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD)-positive status. HRD is defined by either a deleterious or suspected deleterious BRCA mutation, or genomic instability in patients with disease progression greater than six months after response to the last platinum-based chemotherapy.
Small Study Shows T-Cell Activity in Pancreatic Cancer
When treated with their own nonengineered T cells plus chemotherapy, six of seven patients with inoperable or metastatic pancreatic cancer showed objective responses or stable disease, according to the results of a study reported at the American Association for Cancer Research’s Immune Cell Therapies for Cancer conference in July 2019.
Plan Ahead to Ensure Consistency in Patient Care and Communication During Drug Shortages
A manufacturing delay leading to a shipping delay caused the October 2019 vincristine shortage, according to a letter Pfizer sent to its customers on October 18; the U.S. Food and Drug Administration first reported the shortage on October 16. It affects both the 1 mg/ml and 2 mg/2 ml single-dose ONCO-TAIN™ glass fliptop vials.
Oncology Drug Reference Sheet: Darolutamide (Nubeqa®)
Based on the results of the phase III ARAMIS trial that demonstrated significant improvement in metastasis-free survival, the U.S. Food and Drug Administration approved darolutamide under priority review on July 30, 2019. Darolutamide is approved for nonmetastatic, castration-resistant prostate cancer in men receiving concurrent gonadotropin-releasing hormone therapy or who have had bilateral orchiectomy.
Getting the Right Treatment at the Right Time Reduces Inequities in Breast Cancer Survival
Although death rates from breast cancer have been falling, the trend has not been equal among all women. Looking at breast cancer survival on a population level can tell us how effective our public health and healthcare systems are at early diagnosis, delivery of evidence-based treatment, and management of follow-up care.
FDA Approves Daratumumab for Transplant-Eligible Multiple Myeloma
On September 26, 2019, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex®) for adult patients with multiple myeloma in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant.
FDA Rolls Out More New Indications for Existing Agents
Pembrolizumab, lenalidomide, and avelumab all received new treatment indications in spring 2019. Here’s what you need to know about dosing, adverse events, and other nursing considerations for these and other drugs that the U.S. Food and Drug Administration (FDA) approved from April–June 2019.
FDA Approves Apalutamide for Metastatic Castration-Sensitive Prostate Cancer
On September 17, 2019, the U.S. Food and Drug Administration (FDA) approved apalutamide (ErleadaTM) for patients with metastatic castration-sensitive prostate cancer. Apalutamide was initially approved in 2018 for patients with non-metastatic castration-resistant prostate cancer.
Vaccine May Boost CAR T-Cell Activity in Solid Tumors
Researchers are testing a new approach using an amphiphilic cancer vaccine to deliver CAR T-cell therapy to solid tumors, and the results of preclinical studies are promising, according to findings published in the journal Science.
FDA Approves Combination Pembrolizumab Plus Lenvatinib
On September 17, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the combination of pembrolizumab (Keytruda®) plus lenvatinib (Lenvima®) for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation.
Oncology Formulations Not Affected by Bevacizumab Recall
On September 3, 2019, AmEx Pharmacy issued a voluntary recall of two dosages of injectable bevacizumab. Although injectable bevacizumab is used in cancer treatment, the formulations affected by the recall are for much smaller dosages that are used to treat eye diseases (i.e., macular degeneration and diabetic retinopathy).
Oncology Drug Reference Sheet: Venetoclax
Venetoclax (Venclexta®) was approved by the U.S. Food and Drug Administration on May 15, 2019, for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) as a single agent or in combination therapy. Previously, it had been approved in late 2018 for use in combination therapy for acute myeloid leukemia (AML) in older adults or those with significant comorbidities.
FDA Approves Fedratinib for Myelofibrosis
On August 16, 2019, the U.S. Food and Drug Administration (FDA) approved fedratinib (Inrebic®) for adults with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis.
FDA Approves Entrectinib for NTRK Solid Tumors and ROS-1 NSCLC
On August 15, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to entrectinib (RozlytrekTM) for adults and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory standard therapy.
CAR T Cells Show Promise in Solid Tumors
Two recent studies demonstrated CAR T-cell therapy activity in certain types of solid tumors, according to results presented at the American Society of Clinical Oncology annual meeting. The CAR T cells used new targets outside of the CD19 targets used for the therapy’s current approvals in leukemia and lymphoma.
Geriatric Oncology Ambulatory Care Clinics Address Older Patients’ Needs
Traditionally defined as patients aged 65 and older, older adults make up the majority of patients with cancer. Ambulatory care clinics with a specialized focus on older patients with cancer can provide age-specific care and an interprofessional team of providers well versed in cancer, aging, and geriatric assessment. Through geriatric oncology ambulatory care clinics, providers can work together to identify and coordinate plans to individualize treatment and supportive care for older patients.
The Case of the Pregnancy Predicament
A 33-year-old woman presents to the emergency department with fever, weight loss, and dyspnea. She is five months pregnant. A computed tomography (CT) chest scan without contrast shows a large mediastinal mass. Biopsy demonstrates Hodgkin lymphoma (HL), but magnetic resonance imaging (MRI) of her abdomen and pelvis without contrast is negative for lymphadenopathy. Her echocardiogram and pulmonary function testing are normal.
FDA Approves Pembrolizumab for Advanced Esophageal Squamous Cell Cancer
On July 30, 2019, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda®) for patients with recurrent, locally advanced or metastatic, squamous cell carcinoma of the esophagus (ESCC) whose tumors express PD-L1 (combined positive score [CPS] ≥10), as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.
Oncology Drug Reference Sheet: Atezolizumab’s Indications for Breast and Lung Cancer
The U.S. Food and Drug Administration (FDA) first approved atezolizumab (Tecentriq®) in 2016, but it received additional approvals when used in combination treatments for locally advanced or metastatic triple negative breast cancer (TNBC) and small cell lung cancer (SCLC) in March 2019.
Which Tumor Marker Can Be Used to Assess Stage, Prognosis, Response to Treatment?
Which tumor marker can be used to assess stage, prognosis, response to treatment in germ cell tumors, lymphoma, melanoma, acute leukemia, and neuroblastoma?
A. Programmed death ligand 1 (PD-L1)
C. Cytokeratin fragment 21-1
D. Lactate dehydrogenase
Fresenius Kabi Issues Voluntary Nationwide Recall of Two Lots of Fluorouracil Injection Because of the Potential for Glass Particulate
Fresenius Kabi USA, LLC, is voluntarily recalling two lots of fluorouracil injection, USP 5 g/100 mL (50 mg/mL), 100 mL fill in 100 mL vials, to the user level because of the potential for glass particulate. The affected lots, distributed between December 6, 2018, and February 20, 2019, are listed below:
Collaboration Is Key to CAR T-Cell Therapy Management Across Settings
As of February 2019, only 160 institutions across the United States are certified to administer CAR T-cell therapy, meaning many eligible patients may need to be referred to a treatment center outside of the local ambulatory or community cancer center where they had previously received treatment. The transition from primary oncologist to certified center and back again requires careful coordination to ensure important steps and information aren’t lost.
FDA Grants Accelerated Approval to Selinexor for Multiple Myeloma
On July 3, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to selinexor (XpvioTM) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.
Test Predicts Which Women Will Benefit From Chemo for Breast Cancer
A prediction test accurately identifies which women with estrogen receptor (ER)-positive, HER2-negative breast cancer will benefit from adjuvant chemotherapy, according to the results of a study published in Breast Cancer Research and Treatment.
FDA Approves Daratumumab for Multiple Myeloma Ineligible for Autologous Stem Cell Transplant
On June 27, 2019, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex®) in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
New CAR T-Cell Targets Show Safe Results in Early Clinical Trials
Findings from two phase I clinical trials presented at the American Association for Cancer Research 2019 annual meeting indicate that targeting CAR T cells against mesothelin for advanced solid tumors and HER2 for advanced sarcoma is safe and shows clinical antitumor activity.
FDA’s Latest Approved Drugs and Indications Include Two Oral Agents
Because two oral therapies received new indications in the U.S. Food and Drug Administration’s (FDA’s) most recent round of approvals, oncology nurses will want to focus on ways to manage patients in the home. Assessing oral adherence, encouraging patients to report adverse events, and ensuring their understanding of complex dosing regimens are critical components of nursing care. ONS offers an oral adherence toolkit and oral chemotherapy patient education sheets to help with patient management.
Personalized Combination Therapies Yield Better Cancer Outcomes
In a perpetual search to refine research and scientific advancements in the pursuit of fighting cancer, the National Institutes of Health (NIH) is investing in research that will help practitioners further understand how treatments and combinations of treatments can benefit patients. Through a focus on precision oncology, researchers are examining which combinations of therapies would work best for each individual patient based on a number of factors, including genetics and genomics.
Oncology Drug Reference Sheet: Combination Trastuzumab and Hyaluronidase-Oysk
A new product that combines trastuzumab and hyaluronidase (Herceptin Hylecta™) received U.S. Food and Drug Administration approval in February 2019 for the treatment of HER2-overexpressing breast cancer. The approval was based on the results of two randomized trials: HannaH and SafeHER.
FDA Approves Pembrolizumab for Metastatic Small Cell Lung Cancer
On June 17, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda®) for patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.
FDA Approves Pembrolizumab for First-Line Treatment of HNSCC
On June 10, 2019, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda®) for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC).
FDA Approves Polatuzumab Vedotin-piiq for Diffuse Large B-Cell Lymphoma
On June 10, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to polatuzumab vedotin-piiq (PolivyTM), a CD79b-directed antibody-drug conjugate indicated in combination with bendamustine and a rituximab product for adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, after at least two prior therapies.
Nurses Are Crucial to Developing Tools, Best Practices for Novel Therapies
Advanced practice RNs (APRNs), especially those with Doctorate of Nursing Practice degrees, in clinics across the country must not only focus on managing care for patients on novel therapies like immunotherapy but must also look at toxicities and adverse events from a population perspective. APRNs should look across all patients and disease types receiving the same novel treatments and recognize toxicity patterns to determine best practices for patient management.
Novel Therapies: How CAR T Cells and Biosimilars Are Changing Cancer Care
Clinical practice is in a constant state of evolution as new guidelines are released, drugs are approved for new indications, and technology reshapes the way care is delivered. Patients are also arming themselves with a more-advanced-than-ever knowledge and understanding of health care, and providers may be fielding new questions from patients and caregivers about novel treatments such as chimeric antigen receptor (CAR) T-cell therapy and biosimilars.
FDA Updates REMS and Black Box Warnings for Blinatumomab
In May 2019, the U.S. Food and Drug Administration (FDA) added new clarifications to its risk evaluation and mitigation strategy and black box warnings for blinatumomab (Blincyto®). Blinatumomab is a bispecific, CD19-directed CD3 T-cell engager indicated for the treatment of adults and children with (a) B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease greater than or equal to 0.1% or (b) relapsed or refractory B-cell precursor ALL.
FDA Approves Lenalidomide for Follicular and Marginal Zone Lymphoma
On May 28, 2019, the U.S. Food and Drug Administration (FDA) approved lenalidomide (Revlimid®) in combination with a rituximab product for previously treated follicular lymphoma and previously treated marginal zone lymphoma.
FDA Approves Alpelisib for Metastatic Breast Cancer
On May 24, 2019, the U.S. Food and Drug Administration (FDA) approved alpelisib (Piqray®) in combination with fulvestrant for postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.
FDA Approves Ruxolitinib for Acute Graft-Versus-Host Disease
On May 24, 2019, the U.S. Food and Drug Administration (FDA) approved ruxolitinib (Jakafi®) for steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older.
Oncology Drug Reference Sheet: Talazoparib
Initially approved in 2018, talazoparib (Talzenna®) capsules are indicated for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene HER2-negative locally advanced or metastatic breast cancer.
FDA Approves Avelumab Plus Axitinib for Renal Cell Carcinoma
On May 14, 2019, the U.S. Food and Drug Administration (FDA) approved avelumab (Bavencio®) in combination with axitinib for first-line treatment of patients with advanced renal cell carcinoma.
FDA Approves Ado-Trastuzumab Emtansine for Early Breast Cancer
On May 3, 2019, the U.S. Food and Drug Administration (FDA) approved ado-trastuzumab emtansine (Kakcyla®) for the adjuvant treatment of patients with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.
FDA Approves Ivosidenib as First-Line Treatment for AML With IDH1 Mutation
On May 2, 2019, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo®) for newly-diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test, in patients who are at least 75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy.
Stay Up to Date on Clinical Treatments for Metastatic CRC
Metastatic colorectal cancer (CRC) remains a significant health problem as the second leading cause of cancer death in the United States and the fourth most frequently diagnosed cancer. Despite improvements in some age groups, its incidence has actually been increasing in patients younger than 50 years. The cause of this trend is currently unknown.
Oncology Drug Reference Sheet: Cabozantinib
Cabozantinib (Cabometyx®) received an additional U.S. Food and Drug Administration (FDA)-approved indication in January 2019 for use in patients with hepatocellular carcinoma (HCC) who have already been treated with sorafenib. It received prior approval for the treatment of renal cell carcinoma in 2017. The research leading to the approval in the HCC setting showed improved overall survival, progression-free survival, and overall response in the cabozantinib treatment arm.