FDA Approves Pralsetinib for Lung Cancer With RET Gene Fusions
On September 4, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pralsetinib (Gavreto™) for adult patients with metastatic, RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.
FDA Approves First Liquid Biopsy NGS Companion Diagnostic Test for NSCLC
On August 7, 2020, the U.S. Food and Drug Administration (FDA) approved the Guardant360 CDx assay as the first liquid biopsy companion diagnostic that also uses next-generation sequencing (NGS) technology to identify patients with specific types of mutations of the epidermal growth factor receptor gene in patients with metastatic non-small cell lung cancer (NSCLC). This is the first approval to combine two technologies in one diagnostic test to guide treatment decisions.
Manage Immune-Related Adverse Events in Patients on Durvalumab
Durvalumab immunotherapy became a new standard of care for patients with stage III unresectable non-small cell lung cancer whose disease did not progress following two cycles of platinum-based chemoradiotherapy after its approval in February 2018, and in March 2020, its indication was expanded for use as first-line treatment in patients with extensive-stage small cell lung cancer as well. Key to keeping patients on immunotherapy treatment and giving them the best chance at long-term survival is effective management of immune-related adverse events.
NIH Study Links Cigarette Smoking to Higher Stroke Risk in African Americans
The disproportionate adverse health impact from smoking on African Americans is striking. Although oncology nurses are well aware of tobacco’s carcinogenic effects, they also need to understand the implications for comorbid conditions they may see in smokers with cancer. A recent study, through the National Institutes of Health (NIH), confirmed that African Americans have a 2.5 times higher incident of smoking-related strokes than those who never smoke.
Nurses Obliged to End Racism; Tobacco Industry's Manipulative Marketing
Along with many other healthcare organizations, including ONS, last week the American Nurses Association (ANA) took a bold stand against racism, calling it a public health crisis. On June 12, 2020, ANA President Earnest Grant shared how racism is embedded in health care and what nurses should do to end it.
FDA Approves Atezolizumab for First-Line Treatment of Metastatic NSCLC With High PD-L1 Expression
On May 18, 2020, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq®) for first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 staining ≥ 50% of tumor cells [TC] or PD-L1-stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area), with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations.
FDA Approves Nivolumab Plus Ipilimumab for First-Line Metastatic Non-Small Cell Lung Cancer
On May 15, 2020, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab (Opdivo®) and ipilimumab (Yervoy®) as first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥ 1%), as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
FDA Approves Selpercatinib for Lung and Thyroid Cancers With RET Gene Mutations or Fusions
On May 8, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to selpercatinib (Retevmo™) for adult patients with metastatic, RET fusion–positive non-small cell lung cancer (NSCLC); adult and pediatric patients aged 12 or older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy; and adult and pediatric patients aged 12 or older with advanced or metastatic RET fusion–positive thyroid cancer who require systemic therapy and who are refractory to radioactive iodine (if radioactive iodine is appropriate). This is the first drug approval for RET genetic alterations.
FDA Grants Accelerated Approval to Capmatinib for Metastatic Non-Small Cell Lung Cancer
On May 6, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to capmatinib (Tabrecta™) for adult patients with metastatic non-small cell lung cancer whose tumors have a mutation that leads to mesenchymal-epithelial transition exon 14 skipping, as detected by an FDA-approved test. It is the first drug approval for this specific patient population and the first targeted therapy for the indication.
House Tells FDA to Ban E-Cigarettes During COVID-19
On April 1, 2020, the U.S. House of Representatives Subcommittee on Economic and Consumer Policy asked the U.S. Food and Drug Administration (FDA) to clear the market of e-cigarettes because of the COVID-19 coronavirus pandemic. It was responding to FDA’s request to give e-cigarette manufacturers four additional months to submit applications to stay on the market before enforcing a ban.
FDA Approves Durvalumab for Extensive-Stage Small Cell Lung Cancer
On March 27, 2020, the U.S. Food and Drug Administration (FDA) approved durvalumab (Imfinzi®) in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).
Smoking Rates Are Low, But Here’s How They Can Be Lower
Although U.S. smoking rates have hit an all-time low of 14%, 34 million American adults are still considered active smokers, according to the U.S. surgeon general’s January 2020 report on smoking cessation. It’s the first new report focused directly on smoking cessation from the surgeon general’s office in 30 years.
Cancer Death Rates See Largest-Ever Single-Year Drop
Overall U.S. cancer mortality fell 2.2% from 2016 to 2017, the largest reduction for a single year, according to the American Cancer Society’s “Cancer Statistics, 2020,” published in CA: A Cancer Journal for Clinicians.
Study Drug Plus Immunotherapy May Offer New Treatment Option for Lung and Kidney Cancer
Pegilodecakin, an investigational, first-in-class drug currently in clinical trials, is demonstrating positive safety results and measurable responses when used in combination with pembrolizumab or nivolumab in patients with non-small cell lung cancer (NSCLC) or kidney cancer. The findings from the multicenter, phase IB study were published in Lancet Oncology.
FDA Approves Atezolizumab With Paclitaxel Protein-Bound and Carboplatin for Metastatic NSCLC Without EGFR/ALK Aberrations
On December 3, 2019, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq®) in combination with paclitaxel protein-bound and carboplatin for the first-line treatment of adult patients with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.
CDC Promotes Lung Cancer Screening Awareness and Prevention
As the leading cause of cancer death in the United States, lung cancer is pervasive and deadly. But like many cancers, patients have a better chance at successful treatment outcomes and survival if caught early through screening and early detection efforts. Despite lung cancer being the second most diagnosed cancer for men and women, not all Americans are aware of its screening recommendations. To address the gap in awareness, the Centers for Disease Control and Prevention (CDC) is promoting a new public health campaign on the issue.
Model May Help Predict Lung Cancer Risk in Patients With Nodules
A risk-prediction model that combines patients’ health history with clinical characteristics of their lung nodules may help physicians determine which will develop into cancer, according to the results of a study published in Cancer Prevention Research.
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.
Liquid Biopsy Equivalent to Tissue for NSCLC
With faster and equally accurate results, liquid biopsy may be an option for identifying guideline-recommended targeted therapies for non-small cell lung cancer (NSCLC), according to findings presented at the 2019 American Association for Cancer Research Annual Meeting in Atlanta, GA.
Nurses Are Critical to Increasing Awareness of Lung Cancer Screening
Nurses, who are frequently on the front lines of communication with patients at high risk for lung cancer, can play a critical role in increasing awareness of the relatively new option to screen for this deadly condition, Lisa Carter-Harris, PhD, APRN, ANP-C, FAAN, of Memorial Sloan Kettering Cancer Center in New York, NY, said in the Victoria Mock New Investigator Presentation on Saturday, April 13, 2019, at the ONS 44th Annual Congress in Anaheim, CA.
FDA Approves Atezolizumab for Extensive-Stage Small Cell Lung Cancer
On March 18, 2019, the U.S. Food and Drug Administration (FDA) approved atezolizumab in combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small cell lung cancer.
Which of the Following Leads to the Greatest Percentage of Superior Vena Cava Syndrome Cases?
Which of the Following Leads to the Greatest Percentage of Superior Vena Cava Syndrome Cases?
A. Small cell lung cancer
B. Non-Hodgkin lymphoma
C. Non-small cell lung cancer
D. Kaposi sarcoma
Psychosocial Support May Reduce Stigma for Patients With Lung Cancer
Because of the relationship between cigarette smoking and lung cancer, patients who receive a lung cancer diagnosis may feel judgment compared to patients with other cancer diagnoses, which could affect social interactions between family, caregivers, and healthcare professionals. Perceived lung cancer stigma can lead to depression, anxiety, poor self-esteem, guilt, shame, blame, poor social identity, and reduced social support. A recent study indicated that lung cancer stigma might be behind the low lung cancer screening rates among high-risk smokers.
FDA Approves Lorlatinib for Second, Third-Line Treatment of ALK-Positive Metastatic NSCLC
On November 2, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to lorlatinib (Lorbrena) for patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease.
FDA Cracks Down on Vaping Pods Because of High Nicotine Levels in Young Users
In September 2018, the U.S. Food and Drug Administration (FDA) issued more than 1,100 warning letters and fines to retailers and issued 131 fines for selling vaping pod products to minors. The agency also told manufacturers that the industry has 60 days to provide a plan to limit underage access to these products or face penalties.
First-Line Osimertinib for Metastatic Non-Small Cell Lung Cancer
Lung cancer is the second most common cancer in both men and women (after skin cancer) and is the leading cause of cancer death among both men and women. Histology has become an important determinant in choosing therapy for various types of cancer, including non-small cell lung cancer (NSCLC). Currently, biomarker testing is the standard of care in lung cancer; with biomarker testing, patients likely to respond to targeted therapy can be identified. As the number of targeted agents continues to increase, so does the demand for continued biomarker testing and adequate tumor tissue samples.
FDA Grants Nivolumab Accelerated Approval for Third-Line Treatment of Metastatic SCLC
On August 16, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab for patients with metastatic small cell lung cancer (SCLC) with progression after platinum-based chemotherapy and at least one other line of therapy.
Which of the Following Patient Types Is Not Indicated for Lung Cancer Screening With Low-Dose Helical Computed Tomography?
Which of the Following Patient Types Is Not Indicated for Lung Cancer Screening With Low-dose Helical Computed Tomography?
A. Is a current or former smoker
B. Is 55–74 years old
C. Has a 10–20 pack-year history
D. Has a 30 pack-year history but no signs or symptoms of lung cancer
Immunotherapy Plus Chemo Improves Survival in Metastatic Lung Cancer
Combining pembrolizumab and platinum chemotherapy plus pemetrexed doubles survival in patients with nonsquamous non-small cell lung cancer (NSNSCLC) without EGFR or ALK gene mutations, according to the results of a study published in the New England Journal of Medicine.
Patients Report More Satisfaction With Multidisciplinary Care Versus Serial Care for Lung Cancer
Despite the prevalence of multidisciplinary (MD) care for cancer, rigorous studies comparing it to serial care (SC) are lacking. To address the literature gap, researchers explored the use of MD versus SC for lung cancer and presented the findings at the 2018 American Society of Clinical Oncology Annual Meeting.
Tips for Creating a Multidisciplinary Research Team Focused on Symptom Management
Catherine Bender, PhD, RN, FAAN, of the University of Pittsburgh, and Amy Hoffman, PhD, RN, of Michigan State University, shared their experiences in building interdisciplinary research teams to assess symptom management during a session at the 43rd Annual Congress in Washington, DC.
Immunotherapy Opens New Frontiers in Lung Cancer Care
The development of targeted therapies brought new progress to lung cancer treatment and research in the past 20 years, and new options will continue to be available in the future. Roy Herbst, MD, PhD, director of thoracic oncology research program at the Yale Comprehensive Cancer Center at Yale School of Medicine in New Haven, CT, spoke at the 43rd Annual Congress in Washington, DC, on new standards of care for non-small cell lung cancer (NSCLC), immunotherapy for NSCLC, and development of rational drug combinations using biomarkers.
Regular Exercise May Improve Outcomes in Patients With Lung Cancer
In addition to lowering cancer risk, regular exercise before lung cancer surgery may improve postoperative outcomes, especially in lung cancer, according to the results of a literature review published in the British Journal of Sports Medicine.
Despite Awareness, 20% of American Adults Use Tobacco Products
It’s been 20 years since a panel of tobacco executives stood before Congress and admitted that their products were both addictive and linked to cancer. Since then, Americans have shifted their understanding about the use of tobacco products in ways not previously thought possible. These changes in perception and behavior are due in part to the public health initiatives and anti-tobacco campaigns of the last two decades.
FDA Grants Marketing Approval to FoundationOne CDx In Vitro Diagnostic
On November 30, 2017, the U.S. Food and Drug Administration granted marketing approval to the FoundationOne CDx, a next generation sequencing based in vitro diagnostic to detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type.
Study Finds How Smoking Contributes to Epigenetics of Lung Cancer
Although cigarette use has long been linked to lung cancer, scientists have not understood how the earliest changes in lung cells developed. In a study published in Cancer Cell, researchers showed how cigarette smoke sensitized airway cells to genetic mutations that are known to cause lung cancers.
FDA Approves Alectinib for ALK-Positive, Advanced, Metastatic NSCLC
On November 6, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to alectinib (Alecensa) for treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.
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.
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.
“Light” Cigarettes to Blame for Rise in Lung Adenocarcinoma
High-ventilation (light) cigarettes have no health benefits to smokers and have likely contributed to increased incidence of adenocarcinoma deep in the lungs, according to the results of a new study published in the Journal of the National Cancer Institute.
FDA Broadens Ceritinib Indication to Previously Untreated ALK-Positive Metastatic NSCLC
On May 26, 2017, the U.S. Food and Drug Administration granted regular approval to ceritinib (Zykadia®, Novartis Pharmaceuticals Corp.) for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
FDA Grants Accelerated Approval to Pembrolizumab in Combination With Pemetrexed and Carboplatin for Treatment of Metastatic Non-Squamous NSCLC
On May 10, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab in combination with pemetrexed and carboplatin for the treatment of patients with previously untreated metastatic non-squamous non-small cell lung cancer.
FDA Grants Accelerated Approval to Brigatinib for ALK-Positive NSCLC
On April 28, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to brigatinib for the treatment of patients with metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.
Recent FDA-Approved Drugs Offer More Options for NSCLC and Other Cancers
The end of 2016 proved to be a busy and exciting time for cancer breakthroughs, seeing eight new U.S. Food and Drug Administration (FDA) approvals for immunotherapy and biotherapy. Following is a summary of cancer-related FDA approvals in the last quarter of 2016, indications for treatment, and associated clinical implications.