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.
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Durbin Calls Out FDA; Medicare for All Support; Cancer Mortality Drops
In a letter to the U.S. Food and Drug Administration (FDA), Senator Dick Durbin (D-IL) shared harsh criticism for the agency’s lack of attention to the youth smoking epidemic. His letter from May 29, 2019, detailed efforts that the agency could be taking to curb the rise in youth tobacco use. The smoking cessation community, of which ONS is a palpable member, has sided with Durbin on the importance of continued FDA oversight on e-cigarettes and the vaping industry’s kid-friendly, fun-flavored tobacco products. Groups like the Campaign for Tobacco Free Kids have been forceful in comments to the agency about the need for stricter regulations on products.
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Think Tank Will Explore Nurse Leadership Development Initiatives
On Sunday, April 14, 2019, the ONS Board of Directors held a face-to-face meeting at the end of a highly successful ONS 44th Annual Congress in Anaheim, CA. New directors took office and new plans unfolded for fostering nurse leaders and supporting ONS chapters.
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.
How ONS Is Supporting ONNs’ Professional Development
Professional development needs of oncology nurse navigators (ONNs) have not been clearly identified, both for novice and more experienced navigators. Although some work has begun to define training for novice ONNs, most information about education for experienced ONNs comes from evaluation data and anecdotal reports.
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.
Practice These Five Self-Care Strategies in Less Than Five Minutes
Oncology nursing is a rewarding profession that offers nurses opportunities to build meaningful relationships with patients and families, manage complex patient situations, and provide compassionate care during a scary time in someone’s life. But what makes oncology nursing so special can also make nurses more vulnerable to occupational stress, which can lead to compassion fatigue or burnout.
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.
FDA Cautions That Robotic Devices Are Not Approved for Mastectomy or Other Women’s Cancer Surgeries
Because of limited preliminary evidence that the use of robotic-assisted surgical devices for treatment or prevention of women’s cancers may be associated with diminished long-term survival, the U.S. Food and Drug Administration (FDA) issued a reminder warning to healthcare providers and the public in February 2019 that the technique has not been FDA approved for this purpose.