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:
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.
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.
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.
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 Links Breast Implants to Increased ALCL Risk
People with breast implants have a risk of developing breast implant-associated anaplastic large cell lymphoma (ALCL), the U.S. Food and Drug Administration (FDA) announced in April 2019. Typically the cancer is limited to the scar tissue and fluid near an implant, but some patients experience spread throughout the body. The risk increases with textured implants in particular.
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.
Healthcare Financial Problems; ACA Reduced Disparities; FDA Project Facilitate
Health care is driving domestic policy agenda, and voters have shown it’s a crucial component in their decision making. The money associated with healthcare costs has been a driving factor in politics year after year. Public opinion polling found that health care is the most important factor when it comes to financial burden for Americans, reports from 2018 indicated that Americans spent more than $88 billion on health care alone.
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.
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.
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.
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.
Changing Leadership Won’t Affect FDA’s Role in Public Health, Awareness, and Prevention
Nestled in the sleepy suburbs of Washington, DC, lies an influential agency that continues to have a growing impact on every American’s life. In fact, public opinion surveys indicate that the agency enjoys a broad range of support in the federal government and across the country in its work protecting people. Seen almost daily on the evening news, FDA encompasses a vast network of public health priorities important to many people’s daily lives.
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.
Make Nicotine Nonaddictive to Reduce Tobacco-Related Disease and Death
U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, released a statement on March 28, 2019, about FDA’s new efforts to reduce tobacco-related disease and death through greater, far-reaching regulation on the tobacco industry. Coming on the heels of his announced departure from his role as of June 2019, the work would ensure his legacy as a staunch proponent of smoking cessation.
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.
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.
NCI’s Sharpless Appointed Acting FDA Commissioner
In March 2019, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, surprised the healthcare community by announcing his resignation, set to take effect in June 2019. With 18 months still remaining in the commissioner’s term, speculation arose throughout the healthcare advocacy community as to who might fill the position. Not long after Gottlieb’s announcement, the Trump administration named National Cancer Institute (NCI) Director Ned Sharpless, MD, as the acting commissioner of the FDA.
FDA Approves Pembrolizumab Plus Axitinib for Advanced Renal Cell Carcinoma
On April 19, 2019, the U.S. Food and Drug Administration (FDA) approved pembrolizumab plus axitinib for the first-line treatment of patients with advanced renal cell carcinoma.
Nurses Must Be Pharmacovigilant With Emerging Cancer Treatments
The field of cancer care is changing and evolving like never before. In 2018, the U.S. Food and Drug Administration (FDA) approved a number of new biosimilars, targeted agents, and agents that target certain mutations regardless of tumor site. New requirements for accreditation and reimbursement mean oncology nurses are being used in a growing number of new or developing roles including navigation and survivorship. On Thursday, April 11, 2019, Kathleen Wiley, RN, MSN, AOCNS®, addressed these emerging trends and more in a clinical chat at the ONS 44th Annual Congress in Anaheim, CA.
$88 Billion for Health Care; Raising the Tobacco Age; 2020 Healthcare Push
According to a Gallup Poll released on April 2, 2019, Americans borrowed approximately $88 billion to pay for health care in 2018. At a National Academies of Science healthcare conference on April 4, the main takeaway was that many Americans surveyed reported that they could not afford to have a serious illness like cancer. The cost of care, even with insurance, is more than many can financially withstand. Oncology nurses know how patients must maneuver through the system to defer costs, sometimes resulting in delayed or alternative approaches to care.
FDA Oncology Center of Excellence Establishes a Commitment to Patients
The U.S. Food and Drug Administration’s (FDA’s) mission is primarily to protect the American public by regulating the sale and development of consumer items like cosmetics, food, tobacco products, medication, and much more. However, a lesser known arm is FDA’s Oncology Center of Excellence, established to further prevention, detection, patient-centered research, and cancer-specific education.
Oncology Drug Reference Sheet: Glasdegib
In November 2018, the U.S. Food and Drug Administration (FDA) approved glasdegib (Daurismo™) for use in combination with low-dose cytarabine for treatment of patients with newly diagnosed acute myeloid leukemia who are not eligible for intensive chemotherapy. Data from clinical trials indicated that the regimen is safe for older adults and those with significant comorbidities, such as cardiac disease, poor performance status, or elevated serum creatinine.
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.
Biosimilars, Oral Agents, and Drugs Targeting Genetic Mutations Are Creating a Paradigm Shift in Cancer Treatment
New treatment options continue to emerge for diseases that until recently had limited, if any, treatment choices. Nurses are seeing more changes in the way treatment regimens come together, biosimilars are presenting viable options for patients, and genetic mutations, as opposed to disease sites, are at the forefront of drug development.
Possible NIH Cuts; Sharpless FDA Commissioner; NPs on the Rise
The day the administration releases the president’s budget, outlining funding levels for federal departments and their respective programs, has become an annual event around the Beltway. When that document was unveiled on March 11, 2019, it arrived on Capitol Hill like a lead zeppelin. Under the proposed budget, the National Institutes of Health’s (NIH’s) budget would see a 13% cut, and the National Cancer Institute (NCI) would have its budget reduced by 15%. The dramatic cuts in domestic spending on health, education, and welfare programs were so stark that patient advocacy and provider groups released statements individually and through coalitions to respectfully—or less so—inform decision makers that efforts will begin immediately to advocate for maintained funding levels.
Nursing Workplace Violence; Aggressive Drug Pricing Legislation; Gottlieb Steps Down
Although nurses are the number one trusted profession in the United States for the past 18 years in a row, they’re not necessarily the most protected sector. Hostile workforce environments and exposure to hazardous chemicals are still a part of too many nurses’ daily lives. Recently, the U.S. House Education and Labor Committee held hearings on workforce safety to better understand the what nurses and other healthcare workers endure.
FDA Approves Atezolizumab for PD-L1 Positive Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer
On March 8, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to atezolizumab in combination with paclitaxel protein-bound for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] of any intensity covering ≥ 1% of the tumor area), as determined by an FDA-approved test.
FDA Approves Trastuzumab and Hyaluronidase-oysk Injection for Subcutaneous Use
On February 28, 2019, the U.S. Food and Drug Administration (FDA) approved a trastuzumab and hyaluronidase-oysk injection, for subcutaneous use (Herceptin Hylecta). The drug is a combination of trastuzumab, a HER2/neu receptor antagonist, and hyaluronidase, an endoglycosidase, for the treatment of HER2‑overexpressing breast cancer.
FDA Approves Trifluridine and Tipiracil Tablet for Recurrent Metastatic Gastric or GEJ Adenocarcinoma
On February 22, 2019, the U.S. Food and Drug Administration (FDA) approved trifluridine/tipiracil tablets (Lonsurf)—a fixed combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor—for adult patients with metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.
FDA Commissioner Advocates Against Smoking, New Vaping Devices
When heads of federal regulatory agencies are health and medical professionals with years of research experience, their background helps guide the mission and vision of the department along with the direction of thousands of staff and employees engaged in implementing health policy. U.S. Food and Drug Administration (FDA) Commissioner, Scott Gottlieb, MD, is a clinician and activist, and he acts as a staunch advocate for public health issues—namely the dangers of tobacco use, especially among young Americans.
FDA Approves Pembrolizumab for Adjuvant Treatment of Melanoma
On February 15, 2019, the U.S. Food and Drug Administration (FDA) approved pembrolizumab for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.
Bipartisan Drug Debates; Youth Vaping Epidemic; Socioeconomic Disparities and Cancer
Congress has settled in after the shutdown, and new members have taken their place on committees to begin the real work in Washington, DC. This week, the House and Senate convened similar panels to discuss the bipartisan goal to lower soaring drug costs for all Americans. Patients and families provided emotional testimony about lost loved ones because of pricey prescription medications that were out of reach.
Surgeon General Declares Youth Vaping an Epidemic
Since their inception, e-cigarettes have made the public health sector uneasy. Initial reports suggested that e-cigarettes could be an opportunity for long-time adult smokers to step down their usage, acting as a bridge to smoking cessation. However, recent reports indicate that youth vaping and e-cigarette use has risen sharply in the past two years—creating an entirely new generation of smokers. U.S. Surgeon General Vice Admiral Jerome Adams, .
Government Shutdown Ends; FDA Threatens E-Cigarettes; New Medicare Part D; Uninsured Rates Rise
After a contentious 35-day-long shutdown, President Trump announced on January 25, 2019, plans for a while talks continue on border security and immigration. Neither party seems optimistic that compromise can happen by the February 15 deadline, and the future is still uncertain.
Oncology Drug Reference Sheet: Lutetium Lu 177 Dotatate
Lutetium Lu 177 dototate (Lutathera®) was approved in January 2018 by the U.S. Food and Drug Administration to treat a specific group of neuroendocrine tumors (NETs) in the gastrointestinal tract. NETs are rare, and the tumors produce hormone-like substances in response to signals from the nervous system.
Pre-Existing Condition Resolution; Teen Vaping; Drug Pricing Talks
Debates like the one facing the constitutionality of the Affordable Care Act (ACA) are what American democracy is built on. Checks and balances for each branch of government—often with authority undulating back to state governments—provide numerous opportunities for policy issues to change and develop through legislative, regulatory, and judicial review. Recently, U.S. Senator Patty Murray (D-WA) and Senator Maria Cantwell (D-WA) have reintroduced a resolution that authorizes Senate Legal Counsel to defend Americans with preexisting conditions against a Republican Attorneys General lawsuit facing the ACA.
Short-Term Insurance Plans; FDA Curbs Youth Vaping; Drug Cost Legislations
Short-term insurance plans were and the rising costs for its health plans after deep funding cuts to the law. But, in doing so, the Trump administration has allowed new, seemingly unregulated temporary insurance plans to emerge that appear to prey on vulnerable policyholders, offering limited coverage at high prices. On January 8, Democrats on short-term insurance plans.
Biosimilars and Oral Agents Lead New Approvals in the Cancer Setting
A majority of the U.S. Food and Drug Administration (FDA) approvals for cancer agents in the latter part of 2018 represented second and third approvals for new indications in other disease sites. Many were given expedited approval, but with that comes the potential that the incidence of adverse events may be underrepresented because fewer patients received the agents in a clinical trial setting.
FDA Approves Romiplostim for Pediatric Patients With Immune Thrombocytopenia
On December 14, 2018, the U.S. Food and Drug Administration (FDA) approved romiplostim for pediatric patients one year of age and older with immune thrombocytopenia for at least six months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
HPV 9-Valent Vaccine Approved for People Aged 27–45
In October 2018, the U.S. Food and Drug Administration expanded the approved use of the human papillomavirus (HPV) 9-valent vaccine to include women and men aged 27–45 years. Previously, the vaccine had been approved for males and females aged 9–26 years, but the expanded approval was granted after the application had undergone priority review.
FDA Approves Rituximab-ABBS as Biosimilar to Rituximab for Non-Hodgkin Lymphoma
On November 28, 2018, the U.S. Food and Drug Administration (FDA) approved rituximab-abbs as the first biosimilar to rituximab for patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy.