FDA Approves Sirolimus Protein-Bound Particles for Malignant Perivascular Epithelioid Cell Tumor
On November 22, 2021, the U.S. Food and Drug Administration (FDA) approved sirolimus protein-bound particles for injectable suspension (Fyarro™) for adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).
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Oncology Drug Reference Sheet: Sotorasib
After clinical trials demonstrated an overall response rate of 36% and median response duration of 10 months, the U.S. Food and Drug Administration granted sotorasib (LumakrasTM) accelerated approval on May 28, 2021, for the treatment of adults with KRAS G12C–altered locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.
Exercise the Evidence: How I Moved From an Idea to Program Development
As a clinical nurse specialist (CNS) with a cardiovascular background, I have seen the evidence-based benefits of exercise in a variety of settings. However, several years ago, when I was working as a CNS on an acute inpatient oncology unit, I noticed that exercise was not regularly included in care plans. As I learned from staff, this was done out of concern that patients needed to rest to save their energy.
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New NIH Program Aims to Increase Gene Therapies for Rare Diseases
To accelerate the development of gene therapies for the 30 million Americans who have been diagnosed with a rare disease, in October 2021 the National Institutes of Health (NIH), U.S. Food and Drug Administration (FDA), 10 pharmaceutical companies, and five nonprofit organizations announced the creation of the Bespoke Gene Therapy Consortium (BGTC). The consortium is optimizing and streamlining the gene therapy development process to help fill the unmet medical needs of people with rare diseases.
Legislators Want Medicare to Negotiate Drug Prices to Improve Access and Affordability
Few political and policy issues resonate with all Americans as much as the costs of prescription medications, particularly those for acute and chronic diseases that affect the body and spirit, like cancer. Seizing the opportunity for real change, in August 2021 President Joe Biden made a major announcement about his administration’s intent to change the dynamic on the financial impact of drugs and government oversight.
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FDA Permits Marketing of E-Cigarette Products, Marking First Authorization of Its Kind
Under the authority given in the Family Smoking Prevention and Tobacco Control Act, in October 2021 the U.S. Food and Drug Administration (FDA) authorized the marketing of three new electronic nicotine delivery system (ENDS) products, “marking the first set of ENDS products ever to be authorized by FDA through the Premarket Tobacco Product Application pathway.” The agency made the announcement it continues its review of thousands of tobacco and e-cigarette products’ marketing applications.
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Mid-Century Antibiotic May Offer Options After PARP Inhibitor Resistance
Novobiocin, an antibiotic discovered during the 1950s, may be a potential second-line therapy for patients whose tumors have become resistant to poly (ADP-ribose) polymerase (PARP) inhibitors, researchers reported in Nature Cancer. The finding may open up new options for patients with BRCA-variant disease such as breast, ovarian, pancreatic, and prostate cancer.
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Maryland Governor Announces Steps to Increase Nursing Workforce Statewide
Out-of-state RNs can now practice in Maryland and certain qualified nursing students are fast tracking graduation, according to Maryland Governor Larry Hogan’s (R-MD) September 2021 announcements. The Old Line State’s steps will help increase the workforce and curtail the nursing shortage.
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Defining Individual Biosignatures Through Precision Health Symptom Science Helps Nurses Deliver Even Better Care
Understanding the underlying mechanisms of cancerrelated symptoms enables oncology nurses to provide the best patient-centered care. Biosignatures are indicators of life, and in disease, they contribute to the determination of clinical profiles. Identifying specific biologic markers associated with similar patient characteristics and symptoms may help us create tailored interventions for improved symptom management.
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ONS Member Naomi Cazeau Joins Sepsis Alliance Advisory Board
In addition to her daily practice as a nurse practitioner at Memorial Sloan Kettering Cancer Center in New York, NY, ONS member Naomi Cazeau, RN, MSN, ANP-BC, AOCNP®, is using her leadership skills to make a difference in advocating for patients on a broader level. In October 2021, the Sepsis Alliance appointed her to its advisory board to help guide the organization’s mission of improving awareness and care.