FDA Provides COVID-19 Guidelines for Patients With Cancer and Healthcare Providers
As the United States combats the COVID-19 coronavirus pandemic, federal agencies like the U.S. Food and Drug Administration’s (FDA’s) Oncology Center of Excellence (OCE) are reassuring specific populations, such as those in the cancer community, that the agency is still patient-centered in its mission.
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).
FDA Issues Guidance for Conducting Clinical Trials During COVID-19
On March 18, 2020, the U.S. Food and Drug Administration (FDA) issued a guidance for industry, investigators, and institutional review boards conducting clinical trials during the COVID-19 coronavirus pandemic in recognition that it may affect the conduct of clinical trials of medical products, including drugs, devices, and biologic products.
FDA Requires New Health Warnings for Cigarette Packages, Advertisements
Change at the federal level takes time and perseverance. Thanks to great effort from the smoking cessation community—including ONS—the federal government is updating package and advertising warning for tobacco products for the first time since 1984. Advocates have been calling on agencies to exercise authority over tobacco products along with their marketing and distribution, and on March 17, 2020, the U.S. Food and Drug Administration (FDA) issued a final rule requiring new health warning labels for cigarette packages and advertisements.
FDA Issues New Guidance for Certain REMS Drugs During COVID-19
To address the COVID-19 coronavirus pandemic, on March 22, 2020, the U.S. Food and Drug Administration (FDA) issued a new guidance to sponsors and healthcare providers regarding certain Risk Evaluation and Mitigation Strategy (REMS)-required testing during this time.
FDA Facilitates Access to Crucial Medical Products, Including PPE and Ventilators, for COVID-19
On March 22, 2020, the U.S. Food and Drug Administration took action to increase the availability of ventilators, accessories, and other respiratory devices during the COVID-19 coronavirus pandemic to support patients with respiratory failure or difficulty breathing.
FDA Grants Accelerated Approval to Nivolumab and Ipilimumab Combination for Hepatocellular Carcinoma
On March 10, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the combination of nivolumab and ipilimumab (Opdivo® and Yervoy®) for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
BD Issues Class I Recall of Alaris System Infusion Pumps
On February 4, 2020, BD announced a recall of all lots of affected models of its Alaris System pump modules because of multiple system errors, software errors, and use-related errors. On March 6, 2020, the U.S. Food and Drug Administration identified it as a class I recall, its most serious level of recalls, because of the possibility of serious injuries or death.
FDA Approves Isatuximab-irfc for Multiple Myeloma
On March 2, 2020, the U.S. Food and Drug Administration (FDA) approved isatuximab-irfc (Sarclisa®) in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
FDA Revamps Anti-Smoking, Vaping Initiative
The growing rates of teen vaping and e-cigarette use have been a focal point at the national legislative level for the past several years. From the U.S. surgeon general’s youth vaping epidemic announcement to the investigation of vaping industry leader Juul, congressional representatives have been busy addressing the issue.
FDA Approves Neratinib for Metastatic HER2-Positive Breast Cancer
On February 25, 2020, the U.S. Food and Drug Administration (FDA) approved neratinib (Nerlyn®) in combination with capecitabine for adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.
Abandoning E-Cigarettes; Lymphedema Bill Stalls; Global Cancer Cases
Vaping pens and other electronic smoking devices were branded as step-down strategies to help the 60 million Americans who are unable to quit traditional cigarettes. The U.S. Food and Drug Administration even supported the idea initially, but research eventually showed that vaping products contain the same or higher levels of nicotine as other tobacco products and are equally as addictive.
Vaping Ban; Bipartisan Drug Plan; Tobacco Regulation Agency
Despite restrictive legislation raising the age of purchase for tobacco products to 21, vaping remains a top legislative concern, and some believe that vaping restrictions are already out of date. For nearly two decades, youth smoking rates were on the decline. After e-cigarette companies like Juul brought their products to market, those rates have seen a sharp uptick and led the U.S. surgeon general to declare a youth smoking epidemic. Although some progress has been made, the issue remains a top priority for organizations like ONS and its members.
FDA Approves Tazemetostat for Advanced Epithelioid Sarcoma
On January 23, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tazemetostat for adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Oncology Drug Reference Sheet: Entrectinib
Entrectinib was approved by the U.S. Food and Drug Administration in August 2019 as the third tumor-agnostic cancer drug, meaning it targets a specific mutation of the cancer, not the organ of origin. The other two currently approved tumor-agnostic drugs are larotrectinib and pembrolizumab.
FDA Vaping Regulations; CMS Scope of Practice; APPs Improve Health Care
Congress returned from the winter holiday season to an administrative announcement partially curtailing flavored e-cigarettes and vaping mechanisms. Additionally, the U.S. Food and Drug Administration (FDA) began the year with the announcement of a new policy prioritizing enforcement against certain unauthorized flavored e-cigarette products to help curb the youth smoking epidemic. However, to the chagrin of the smoking cessation community, FDA is still allowing menthol and traditional tobacco flavors to be sold as usual, and reports have indicated that teens and other underage users will still opt for traditional products if they’re available.
FDA Approves Avapritinib for Gastrointestinal Stromal Tumors With a Rare Mutation
On January 9, 2020, the U.S. Food and Drug Administration (FDA) approved avapritinib (AyvakitTM) for adults with unresectable or metastatic gastrointestinal stromal tumor harboring a platelet-derived growth factor receptor alpha exon 18 mutation, including D842V mutations.
FDA Approves Pembrolizumab for BCG-Unresponsive, High-Risk Non-Muscle Invasive Bladder Cancer
On January 8, 2020, the U.S. Food and Drug Administration (FDA) approved pembrolizumab for the treatment of patients with Bacillus Calmette-Guerin unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
FDA Finalizes Enforcement Policy on Unauthorized Flavored Cartridge-Based E-Cigarettes
Amid the epidemic levels of youth use of e-cigarettes and the popularity of certain products among children, the U.S. Food and Drug Administration today issued a policy prioritizing enforcement against certain unauthorized flavored e-cigarette products that appeal to kids, including fruit and mint flavors. Under this policy, companies that do not cease manufacture, distribution and sale of unauthorized flavored cartridge-based e-cigarettes (other than tobacco or menthol) within 30 days risk FDA enforcement actions.
FDA Approves Fam-Trastuzumab Deruxtecan-Nxki for Unresectable or Metastatic HER2-Positive Breast Cancer
On December 20, 2019, the Food and Drug Administration granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu®) for patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.
FDA Grants Accelerated Approval to Enfortumab Vedotin-ejfv for Metastatic Urothelial Cancer
On December 18, 2019, the U.S. Food and Drug Administration granted accelerated approval to enfortumab vedotin-ejfv (PadcevTM) for adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting.
FDA Approves Enzalutamide for Metastatic Castration-Sensitive Prostate Cancer
On December 16, 2019, the U.S. Food and Drug Administration (FDA) approved enzalutamide (Xtandi®) for patients with metastatic castration-sensitive prostate cancer.
Drug Importation Resistance; Flavored Vaping Ban; 2020 Candidates' Health Policy
Addressing the rising costs of prescription medications is a key priority for the Trump administration. As patients struggle with the financial burden of high drug prices, the U.S. Food and Drug Administration is reviewing options to import medications from Canada at a lower cost to consumers. However, the plan has major hurdles that FDA must address before it can become a reality.
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.
NINR Acting Director; Vaping Flavor Ban; Drug Pricing 2020
In 2018, long-time National Institute of Nursing Research (NINR) Director Patricia Grady, PhD, RN, FAAN, retired. A national search yielded no new directors, and the National Institutes of Health appointed Principal Deputy Director Lawrence Tabak, DDS, PhD, to serve as acting NINR director. However, when the director of the National Institute of Dental and Craniofacial Research announced she would retire at the end of 2019, Tabak, who previously served as the dental agency’s director, was appointed as the obvious replacement.
FDA Grants Authorization to Eight Smokeless Tobacco Products
Tobacco products are under more scrutiny than ever before. With the rise in youth vaping, the advent of flavored e-cigarettes, and the production of other nicotine delivery systems, the U.S. Food and Drug Administration (FDA) has tightened its review process for new products. The agency is looking to the smoking cessation community, taking insight from the Trump administration, and weighing feedback from other elected officials in the Senate and House of Representatives for ways to protect public health. That said, companies are using technology to create new tobacco-based products, and FDA must find ways to assess harm while balancing free market interests.
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.
Sharpless Returns to NCI; Vape Shop Exemption; Single-Payer State Health Care
Ned Sharpless, MD, an oncologist by training, has had a year of transitions. He began his Washington career as the National Cancer Institute director in 2017, but after two years at the helm, he was tapped to be acting U.S. Food and Drug Administration (FDA) commissioner when Scott Gottlieb stepped down in March 2019. However, after heated discussions with the Senate over the perceived lack of action from FDA regarding restrictions to vaping and tobacco products, the Trump administration likely reconsidered his role at FDA and sought to find a more permanent appointee.
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.
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.
Shalala's Vaping Fight; Pre-Existing Conditions; Trump Nominates Hahn
Vaping has been associated with significant public health effects during the past several months, according to the Centers for Disease Control and Prevention. Congress is making e-cigarette regulation a top priority—especially in the wake of the youth smoking epidemic. Now, several members of Congress have developed their own legislative efforts to address the national issue.
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.
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.
FDA Calls Out Juul; Opioid Crackdown; States Tackle Drug Pricing
With more deaths reported from vaping and a forceful U.S. Senate declaration to the U.S. Food and Drug Administration (FDA) acting commissioner to either enact stronger federal provisions restricting e-cigarettes, flavored tobacco, and inhalants or resign, the Trump administration moved quickly to demonstrate a recognition that cessation is a national, bipartisan concern. FDA sent a warning letter to Juul about its marketing and labeling, and the president, Health and Human Services secretary, and FDA commissioner issued very public statements on the matter, making it clear that federal oversight will be enforced on youth tobacco issues.
FDA Warns of Rare Lung Inflammation With Certain CDK 4/6 Inhibitors
Palbociclib (Ibrance), ribociclib (Kisqali), and abemaciclib (Verzenio) used to treat some patients with advanced breast cancers may cause rare but severe inflammation of the lungs, the U.S. Food and Drug Administration (FDA) announced on September 13, 2019. It approved new warnings about the risk on the prescribing information and package insert for the entire class of cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor medicines. However, “the overall benefit of CDK 4/6 inhibitors is still greater than the risks when used as prescribed,” the agency noted.
Health Care in Campaigns; Respiratory Illness From Vaping; Drug Importation Politics
Chicago ONS Chapter member Janice Phillips, RN, CENP, PhD, FAAN, said it all in her op-ed published on Morning Consult. The entire Democratic field of presidential candidates has declared some form of healthcare overhaul, albeit to varying degrees of change. With expanded access and reduced costs for patients and families as a priority, the centerpiece to most presidential hopefuls’ domestic policy program is redesigning a struggling system.
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).
FDA Takes Stronger Oversight Role of Tobacco Products
As the youth smoking epidemic persists and illnesses related to vaping make the headlines, the U.S. Food and Drug Administration (FDA) is searching for solutions to combat the growing impact of new tobacco and nicotine products. After weeks of public outcry, FDA has doubled down on its regulatory stance, issuing several statements—including new warning letters to large tobacco companies—to reinforce its commitment to aggressive oversight and regulation of new tobacco products.
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.
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.