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.

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.

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.

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.

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.

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.

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.  

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.

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.

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.

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. 

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.

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.

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. 

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.

After a contentious 35-day-long shutdown, President Trump announced on January 25, 2019, plans for a temporary deal to reopen the government for a three-week period 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.

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.

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.

On January 14, 2019, the U.S. Food and Drug Administration (FDA) approved cabozantinib for patients with hepatocellular carcinoma who have been previously treated with sorafenib.

Short-term insurance plans were developed as an attempt to circumvent the Affordable Care Act (ACA) 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 pressed the president for further answers on short-term insurance plans.

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. 

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.

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.

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.

On November 28, 2018, the U.S. Food and Drug Administration (FDA) approved gilteritinib for treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.

On November 26, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to larotrectinib for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, that are either metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory alternative treatments or whose cancer has progressed following treatment.

On November 21, 2018, the U.S. Food and Drug Administration (FDA) approved glasdegib in combination with low-dose cytarabine, for newly-diagnosed acute myeloid leukemia (AML) in patients who are 75 years old or older or who have comorbidities that preclude intensive induction chemotherapy.

On November 16, 2018, the U.S. Food and Drug Administration (FDA) approved brentuximab vedotin in combination with chemotherapy for previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified. This is the first FDA approval for previously untreated PTCL including sALCL.

On November 9, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for patients with hepatocellular carcinoma who have been previously treated with sorafenib.

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.

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.

On October 30, 2018, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) in combination with carboplatin and either paclitaxel or nab-paclitaxel as first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC).

Hazardous drugs are medications known to cause adverse health effects because of exposure in the workplace, according to the National Institute for Occupational Safety and Health. Examples of such agents include chemotherapy drugs, antivirals, hormones, and bioengineered drugs.

On October 16, 2018, the U.S. Food and Drug Administration (FDA) approved talazoparib, a poly (ADP-ribose) polymerase inhibitor, for patients with deleterious or suspected deleterious germline BRCA-mutated, HER2‑negative locally advanced or metastatic breast cancer. Patients must be selected for therapy based on an FDA-approved companion diagnostic for talazoparib.

The Right-to-Try law, which has been in effect since May 2018, may have a misleading name, given that it doesn’t require drug manufacturers to grant access to experimental treatments that have passed phase I trials to any patient who seeks it. Rather, the law grants terminally ill patients the “right to ask” the drug company directly, but the request can be denied for several reasons (e.g., limited supply, expense).

On September 28, 2018, the U.S. Food and Drug Administration (FDA) approved cemiplimab-rwlc for patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.

The Biden Cancer Summit was held in Washington, DC, on September 21, 2018. The day-long event was filled with cancer-related educational sessions—some hosted by ONS leadership—discussing ways to move cancer research and care forward. Formerly dubbed the National Cancer Moonshot Initiative, the country-wide effort to make a quantum leap in cancer care has evolved in into the Biden Cancer Initiative (BCI). BCI’s ongoing work will continue to break down barriers and help providers and researchers overcome obstacles as they work toward progress in cancer care.

On September 24, 2018, the U.S. Food and Drug Administration (FDA) granted regular approval to duvelisib for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies.

As researchers learn more about how combination therapy combats drug resistance and lessens the changes of tumor evasion of the immune system, immune checkpoint inhibitors are receiving approval for a broader range of indications. However, recent U.S. Food and Drug Administration (FDA) approvals have centered around hematologic malignancies and the emergence of two new biosimilars. 

The financial toxicity associated with cancer care is becoming a widely known side effect of cancer treatment. Beyond the disease's physical impact, patients are suffering from overwhelming medical costs, high prescription drug prices, and unforeseen, expensive complications. Those issues, often coupled with the inability to work, are leading to many patients quickly depleting their savings or slipping into debt.

It takes an average of 12 years to move a drug from a new application to approval for a specific indication. Twelve years of clinical trials, documentation of several endpoints, and data surrounding incidence of observed adverse events and expected severity. Twelve years until a broader subset of patients can access the drug. 

On September 13, 2018, the U.S. Food and Drug Administration (FDA) approved moxetumomab pasudotox-tdfk (Lumoxit), a CD22-directed cytotoxin indicated for adult patients with relapsed or refractory hairy cell leukemia who received at least two prior systemic therapies, including treatment with a purine nucleoside analog.

As the opioid epidemic ravages American lives, every federal agency with an opportunity to review access is stepping up efforts to find appropriate lines between offering proper care and potentially enabling abuse. In a recent statement, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, acknowledged the challenge of balancing quality care efforts with overprescribing medications and the potential ease of access to opioids.

The rising price of prescription drugs is an ongoing priority for the Trump administration. As part of the president’s blueprint to lower drug costs, the Department of Health and Human Services (HHS) secretary, Alex Azar, elevated the prescription cost issue throughout many federal agencies to help determine a new course of action.

On August 20, 2018, the U.S. Food and Drug Administration (FDA) approved pembrolizumab in combination with pemetrexed and platinum as first-line treatment of patients with metastatic, non-squamous non-small cell lung cancer, with no EGFR or ALK genomic tumor aberrations.

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.

On August 16, 2018, the U.S. Food and Drug Administration (FDA) approved lenvatinib capsules for first-line treatment of patients with unresectable hepatocellular carcinoma.