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).

Former National Institutes of Health (NIH) Director, Harold Varmus, when asked about cancer treatment, once said, “One of the major advances we’ve had as a result of cancer research is deep recognition of the complexity of cancer. It’s not one disease, it’s lots of different diseases. Every single cancer is different when you look at it on a genetic level.”

On January 26, 2018, the U.S. Food and Drug Administration (FDA) approved lutetium Lu 177 dotatate a radiolabeled somatostatin analog, for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults.

The Oncology Center of Excellence of the U.S. Food and Drug Administration (FDA) is informing healthcare providers about new safety information for Varubi^® (rolapitant) injectable emulsion, a substance P/neurokinin (NK-1) receptor antagonist indicated for the prevention of delayed nausea and vomiting associated with cancer chemotherapy in adults.

On January 12, 2018, the U.S. Food and Drug Administration (FDA) granted approval to afatinib for a broadened indication in first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test.

On January 12, 2018, the U.S. Food and Drug Administration (FDA) granted regular approval to olaparib tablets, a poly (ADP-ribose) polymerase (PARP) inhibitor, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer who have been treated with chemotherapy either in the neoadjuvant, adjuvant, or metastatic setting.

Cancer treatment options continue to multiply as 2017 concludes, with the U.S. Food and Drug Administration (FDA) granting additional new drug approvals and broadening indications for others. Checkpoint inhibitors continue to explode on the scene with accelerated approvals for various indications. Treatment options for hematologic cancers are multiplying. Additionally, the first biosimilar for cancer treatment, bevacizumab-awwb, was approved as a biosimilar to bevacizumab.

On December 19, 2017, the U.S. Food and Drug Administration granted accelerated approval to bosutinib for treatment of patients with newly-diagnosed chronic phase Philadelphia chromosome positive chronic myelogenous leukemia.

On December 19, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to cabozantinib for treatment of patients with advanced renal cell carcinoma (RCC).

U.S. Food and Drug Administration (FDA) commissioners will commonly use their roles to enact new changes that can have a lasting effect on public health for years to come. Despite only being in his position for a few months, Scott Gottlieb, MD, is on track to make a real impression as the head of the FDA.

It’s been 20 years since a panel of tobacco executives stood before Congress and admitted that their products were both addictive and linked to cancer. Since then, Americans have shifted their understanding about the use of tobacco products in ways not previously thought possible. These changes in perception and behavior are due in part to the public health initiatives and anti-tobacco campaigns of the last two decades.

On December 1, 2017, the U.S. Food and Drug Administration approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with HER2-overexpressing breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma).

On November 30, 2017, the U.S. Food and Drug Administration granted marketing approval to the FoundationOne CDx, a next generation sequencing based in vitro diagnostic to detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type.

Every quadrennial presidential cycle, as the newly elected leader moves into the Oval Office, he selects a core group of advisors who are philosophically aligned and eager to make changes in the federal government’s process. However, this is often not as simple as the new administration believes.

On November 16, 2017, the U.S. Food and Drug Administration (FDA) approved sunitinib malate (Sutent, Pfizer Inc.) for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma following nephrectomy.

On November 16, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to obinutuzumab (Gazyva^®, Genentech, Inc.) in combination with chemotherapy, followed by obinutuzumab monotherapy in patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage II bulky, III, or IV follicular lymphoma (FL).

On November 16, 2017, the U.S. Food and Drug Administration (FDA) approved emicizumab-kxwh (Hemlibra^®, Genentech, Inc.) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors.

On November 9, 2017, U.S. the Food and Drug Administration (FDA) granted regular approval to dasatinib (Sprycel^®, Bristol-Myers Squibb Co.) for the treatment of pediatric patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase.

On November 9, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to brentuximab vedotin (Adetris^®, Seattle Genetics, Inc.) for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.

A wide gap in health disparities continues to exist in the United States, affecting countless underserved and underrepresented Americans. Despite some focus on education, assistance, and outreach, pockets of U.S. citizens are still facing healthcare challenges because of their race, socioeconomic status, location, or other disparities. Because many different factors can contribute to a person’s health, the U.S. Food and Drug Administration (FDA) is dedicating research funding to learn more about how people’s life situations have an impact on their overall health.

On November 6, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to alectinib (Alecensa) for treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.

On November 6, 2017, the U.S. Food and Drug Administration granted regular approval to vemurafenib (Zelboraf^®) for the treatment of patients with Erdheim-Chester Disease with BRAF V600 mutation.

In May 2017, Scott Gottlieb, MD, was named as the newest U.S. Food and Drug Administration (FDA) commissioner. He’s since shown a commitment to regulating tobacco and nicotine delivery systems—such as e-cigarettes—especially when it comes to children. In one of his public forums, Gottlieb spoke about the FDA’s commitment to continued oversight and regulation of these products and their distribution, a stance that’s drawn support from the medical community.

On October 31, 2017, the Food and Drug Administration (FDA) granted accelerated approval to acalabrutinib (Calquence™, AstraZeneca Pharmaceuticals, Inc.) for treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy.

On October 25, 2017, the U.S. Food and Drug Administration (FDA) approved the use of rolapitant (Varubi®) IV in combination with other antiemetic agents for adults experiencing delayed chemotherapy therapy-induced nausea and vomiting (CINV). Rolapitant through oral administration had been approved through the FDA in September 2015. The new IV administration route is expected to offer the same results at a lower cost to patients with CINV.