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.

On June 8, 2018, the U.S. Food and Drug Administration (FDA) granted regular approval to venetoclax (Venclexta) for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.

On June 4, 2018, the U.S. Food and Drug Administration (FDA) approved pegfilgrastim-jmdb (Fulphila) as a biosimilar to pegfilgrastim (Neulasta) to decrease the chance of infection as suggested by febrile neutropenia in patients with non-myeloid cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia.

Options and cost are a double-edged sword as biomedical research marches forward and the list of approved drugs expands. More targeted drugs for specific diseases means that more patients have treatment plans that can directly fight their specific disease, possibly resulting in cures.

The U.S. Food and Drug Administration (FDA) is alerting healthcare professionals, oncology clinical investigators, and the public about decreased survival associated with the use of pembrolizumab (Keytruda) or atezolizumab (Tecentriq) as monotherapy in clinical trials to treat patients with metastatic urothelial cancer who have not received prior therapy and who have low expression of the protein programmed death ligand 1 (PD-L1).

On May 15, 2018, the U.S. Food and Drug Administration approved epoetin alfa-epbx (Retacrit™) as a biosimilar to epoetin alfa (Epogen/Procrit) for the treatment of anemia due to chronic kidney disease.

With hopes for more than 1 million participants, the National Institutes of Health (NIH) has launched the All of Us initiative, a radical precision medicine campaign to amass a collective gene pool data repository. The NIH is aiming to shrink our differences and expand on the similarities found in our genetic data. For some, compiling genetic data of an entire country’s citizens may sound very reminiscent of Big Brother from the book 1984. But the amount of information that could be shared and learned from such a massive health database is remarkable.

On May 1, 2018, the U.S. Food and Drug Administration (FDA) approved tisagenlecleucel a CD19-directed genetically modified autologous T-cell immunotherapy, for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma.

On April 30, 2018, the U.S. Food and Drug Administration (FDA) granted regular approval to dabrafenib (Tafinlar ^®) and trametinib (Mekinist^®) in combination for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection.

On April 17, 2018, the U.S. Food and Drug Administration approved fostamatinib disodium hexahydrate tablets for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.

On April 16, 2018, the U.S. Food and Drug Administration (FDA) granted approvals to nivolumab and ipilimumab in combination for the treatment of intermediate or poor risk, previously untreated advanced renal cell carcinoma.

On April 10, 2018, the U.S. Food and Drug Administration (FDA) approved everolimus tablets for oral suspension for the adjunctive treatment of adult and pediatric patients aged 2-years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures. Everolimus is also approved for two other manifestations of TSC: TSC-associated subependymal giant cell astrocytoma (SEGA) and TSC-associated renal angiomyolipoma.

On April 6, 2018, the U.S. Food and Drug Administration (FDA) approved rucaparib, a poly ADP-ribose polymerase inhibitor, for the maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Genetic testing is becoming more recognized among the general public, due in part to news reports and celebrity endorsements. Now, people are seeking to understand cancer risks and prevention measures through genetic information. There are many companies that ask for a mere mouth swab and deliver insight into a person’s DNA. As this becomes more commonplace, those with familial predisposition to cancer will look for ways to understand their own genetic results. Recently, the U.S. Food and Drug Administration (FDA) approved an at-home test identifying some—but not all—breast cancer genes.

On March 29, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to blinatumomab (Blincyto^®) for the treatment of adult and pediatric patients with B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.

It is becoming more commonplace for nurses to find orders for agents with which they are unfamiliar or quite possibly have never administered. Following is a summary of the latest new U.S. Food and Drug Administration (FDA) approvals or indications to keep you up to date in your practice. Of note, this summary contains the approval of yet another biosimilar in trastuzumab-dkst and rolapitant for chemotherapy-induced nausea and vomiting, which includes a safety alert. Early experiences with rolapitant, a NK-1 inhibitor, indicated a risk of hypersensitivity reactions.

Racing against the clock to ensure the government stayed funded through September 2018, President Trump signed the Consolidation Appropriations Act, a $1.3 trillion spending bill that includes funding for a number of key nursing and public health initiatives. The bill, which had made its way through the House of Representatives and the Senate last week, also contains new clarifying language for the Dickey Amendment, ending a 22-year ban on government-funded gun violence research. ONS joined the Nursing Community Coalition—led in part by the efforts of the American Nurses Association—to support evidence-based inquiry into gun violence and its potential impacts on public health.

On March 22, 2018, the U.S. Food and Drug Administration (FDA) approved nilotinib for pediatric patients 1 year of age or older with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior tyrosine-kinase inhibitor therapy.

On March 20, 2018, the U.S. Food and Drug Administration (FDA) approved brentuximab vedotin to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma in combination with chemotherapy.

Legislation ushering experimental drugs and treatments to patients without U.S. Food and Drug Administration (FDA) approval hit a snag on March 13, 2018, after it failed to garner enough votes in the House of Representatives. The right-to-try bill, a priority for the Trump administration, didn’t accrue the two-thirds majority vote needed to pass it along to the Senate. Lawmakers opposed to the bill had lingering questions about the safety concerns connected to bypassing FDA regulations for patients searching for new treatments. Patient advocacy groups have been speaking out against tenets of the bill, expressing concern for removing the FDA from the process.

Breakthroughs and new treatments are moving faster than ever. Getting treatments approved by the U.S. Food and Drug Administration (FDA) is crucial whenever new options are making way to patients with cancer. In February 2018, the FDA approved apalutamide for the treatment of nonmetastatic prostate cancer that continues to grow despite treatment with hormone therapy, the first FDA-approved treatment for nonmetastatic, castration-resistant prostate cancer.

On March 6, 2018, the U.S. Food and Drug Administration (FDA) approved updated dosing information for nivolumab (Opdivo^®). Nivolumab is now the first FDA-approved PD-1 inhibitor that offers a flexible dosing option of every two weeks at 240 mg or every four weeks at 480 mg for most approved indications.

In 2016, former President Obama signed the Comprehensive Addiction and Recover Act (CARA) into law. Since then, some aspects of drug addiction have been decriminalized and refocused as medical issues, helping to remove some of the stigma associated with addiction. Although CARA is a start when tackling addiction issues, several senators—both Republican and Democrat—want to take it a step farther in the national fight against opioid abuse.

On February 26, 2018, the U.S. Food and Drug Administration (FDA) approved abemaciclib (Verzenio™) in combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 HER2-negative advanced or metastatic breast cancer.

With more than 50 new U.S. Food and Drug Administration approvals for cancer therapy in 2017 alone, oncology nurses are challenged about how to keep up with all of the latest practice updates. However, the Philadelphia Area Chapter of the Oncology Nursing Society (PACONS) leadership has taken an active role in helping to ensure their chapter members are given the evidence-based cancer treatment information they need to improve their practice.

On February 16, 2018, the U.S. Food and Drug Administration (FDA) approved durvalumab (Imfinzi) for patients with unresectable stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.

On February 14, 2018, the U.S. Food and Drug Administration (FDA) approved apalutamide (Erleada) for patients with non-metastatic castration-resistant prostate cancer.

On February 7, 2018, the U.S. Food and Drug Administration (FDA) approved abiraterone acetate tablets in combination with prednisone for metastatic high-risk castration-sensitive prostate cancer (CSPC).