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.

On August 8, 2018, the U.S. Food and Drug Administration (FDA) approved mogamulizumab-kpkc (Poteligeo) for adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy.

Healthcare reform has been a hot political topic since before the introduction of the Affordable Care Act. Potential changes in the American healthcare system will be at the hands of which party controls the House of Representatives and the Senate. The upcoming midterm elections in November 2018 could determine a shift in power and potentially add further Medicaid expansion to the list of incoming health care changes.

On July 31, 2018, the U.S. Food and Drug Administration (FDA) approved lusutrombopag (Mulpleta, Shionogi Inc.) for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure.

On July 30, 2018, the U.S. Food and Drug Administration (FDA) approved iobenguane I 131 (Azedra, Progenics Pharmaceuticals, Inc.) for adult and pediatric patients (12 years and older) with iobenguane scan-positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma (PPGL) who require systemic anticancer therapy.

On July 20, 2018, the U.S. Food and Drug Administration (FDA) approved ivosidenib for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test.

In response to the U.S. Food and Drug Administration’s (FDA’s) Advanced Notice of Proposed Rulemaking (ANPRM) on setting a tobacco standard for nicotine levels in combusted cigarettes, ONS submitted comments urging the agency to lower nicotine levels in combusted cigarettes and all tobacco products. Specifically, ONS recommended lowering the level of nicotine to a maximum of 0.4 mg or lower and that the ratio of tar to nicotine stay around 1 to reduce addiction. ONS pointed out that even lower levels of nicotine are harmful to health. ONS also cautioned the agency about the harm of additives in tobacco, including sugar, that counteract reduced nicotine levels.

On July 18, 2018, the U.S. Food and Drug Administration (FDA) expanded the indication for ribociclib (Kisqali) in combination with an aromatase inhibitor for pre/perimenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy.

On July 13, 2018, the U.S. Food and Drug Administration (FDA) approved enzalutamide (Xtandi), for patients with castration-resistant prostate cancer.

On July 10, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to ipilimumab for use in combination with nivolumab for the treatment of patients 12 years of age and older with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

On June 27, 2018, the U.S. Food and Drug Administration (FDA) approved encorafenib and binimetinib (Braftovi and Mektovi) in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.

What is unique about the most recent U.S. Food and Drug Administration (FDA) approvals in the oncology/hematology area is that almost all are for new indications of existing agents as opposed to new agents. This is not surprising because many of the agents target specific bioassays or tumor markers instead of a specific disease site. Oncology nurses need to be aware of the changes because treatments that they have become accustomed to giving for one indication may soon be given for others as well.

On June 7, 2018, the U.S. Food and Drug Administration approved methoxy polyethylene glycol-epoetin beta (Mircera^®, Vifor Pharma Inc.) for the treatment of pediatric patients aged 5–17 years on hemodialysis who are converting from another erythropoiesis-stimulating agent (ESA) after their hemoglobin level was stabilized with an ESA.