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.

On August 15, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to entrectinib (Rozlytrek^TM) 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.

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.

On July 30, 2019, the U.S. Food and Drug Administration (FDA) approved darolutamide (Nubeqa®) for non-metastatic castration-resistant prostate cancer.

After the U.S. surgeon general’s announcement that youth smoking epidemic was in part a result of vaping and tobacco companies’ marketing and advertising of flavored products, federal agencies began looking for ways to address the growing problem. The ease at which elementary and high school students can access vaping mechanisms was a battle cry for former U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, who was an outspoken advocate for regulating and penalizing companies that targeted marketing efforts at young Americans.

From soaring prescription medication costs to surprise medical bills, the issue of high healthcare costs has dominated headlines for months. Both sides of the aisle have been outspoken about the issue in a rare showing of bipartisanship. But despite the attention paid to the issue, little has been done legislatively to corral rising healthcare costs for patients and consumers. The recent announcement that the Senate wouldn’t vote on its healthcare cost bill prior to the August recess has left many wondering if the issue would be addressed at all.

On July 24, 2019, the U.S Food and Drug Administration (FDA) requested that Allergan recall its BIOCELL textured breast implants and tissue expanders because of the associated increased risk of breast implant-associated anaplastic large cell lymphoma; Allergan agreed and is removing the products from the global market.

The U.S. Food and Drug Administration (FDA) first approved atezolizumab (Tecentriq^®) in 2016, but it received additional approvals when used in combination treatments for locally advanced or metastatic triple negative breast cancer (TNBC) and small cell lung cancer (SCLC) in March 2019.

Fresenius Kabi USA, LLC, is voluntarily recalling two lots of fluorouracil injection, USP 5 g/100 mL (50 mg/mL), 100 mL fill in 100 mL vials, to the user level because of the potential for glass particulate. The affected lots, distributed between December 6, 2018, and February 20, 2019, are listed below:

On July 3, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to selinexor (Xpvio^TM) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.

On June 27, 2019, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex^®) in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

Because two oral therapies received new indications in the U.S. Food and Drug Administration’s (FDA’s) most recent round of approvals, oncology nurses will want to focus on ways to manage patients in the home. Assessing oral adherence, encouraging patients to report adverse events, and ensuring their understanding of complex dosing regimens are critical components of nursing care. ONS offers an oral adherence toolkit and oral chemotherapy patient education sheets to help with patient management. 

A new product that combines trastuzumab and hyaluronidase (Herceptin Hylecta™) received U.S. Food and Drug Administration approval in February 2019 for the treatment of HER2-overexpressing breast cancer. The approval was based on the results of two randomized trials: HannaH and SafeHER. 

On June 17, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda®) for patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.

People with breast implants have a risk of developing breast implant-associated anaplastic large cell lymphoma (ALCL), the U.S. Food and Drug Administration (FDA) announced in April 2019. Typically the cancer is limited to the scar tissue and fluid near an implant, but some patients experience spread throughout the body. The risk increases with textured implants in particular.

On June 10, 2019, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda®) for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC).

On June 10, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to polatuzumab vedotin-piiq (Polivy^TM), a CD79b-directed antibody-drug conjugate indicated in combination with bendamustine and a rituximab product for adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, after at least two prior therapies.

Health care is driving domestic policy agenda, and voters have shown it’s a crucial component in their decision making. The money associated with healthcare costs has been a driving factor in politics year after year. Public opinion polling found that health care is the most important factor when it comes to financial burden for Americans, reports from 2018 indicated that Americans spent more than $88 billion on health care alone.

In a letter to the U.S. Food and Drug Administration (FDA), Senator Dick Durbin (D-IL) shared harsh criticism for the agency’s lack of attention to the youth smoking epidemic. His letter from May 29, 2019, detailed efforts that the agency could be taking to curb the rise in youth tobacco use. The smoking cessation community, of which ONS is a palpable member, has sided with Durbin on the importance of continued FDA oversight on e-cigarettes and the vaping industry’s kid-friendly, fun-flavored tobacco products. Groups like the Campaign for Tobacco Free Kids have been forceful in comments to the agency about the need for stricter regulations on products.

In May 2019, the U.S. Food and Drug Administration (FDA) added new clarifications to its risk evaluation and mitigation strategy and black box warnings for blinatumomab (Blincyto^®). Blinatumomab is a bispecific, CD19-directed CD3 T-cell engager indicated for the treatment of adults and children with (a) B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease greater than or equal to 0.1% or (b) relapsed or refractory B-cell precursor ALL.

On May 28, 2019, the U.S. Food and Drug Administration (FDA) approved lenalidomide (Revlimid^®) in combination with a rituximab product for previously treated follicular lymphoma and previously treated marginal zone lymphoma.

On May 24, 2019, the U.S. Food and Drug Administration (FDA) approved alpelisib (Piqray®) in combination with fulvestrant for postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.

On May 24, 2019, the U.S. Food and Drug Administration (FDA) approved ruxolitinib (Jakafi®) for steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older.

Because of limited preliminary evidence that the use of robotic-assisted surgical devices for treatment or prevention of women’s cancers may be associated with diminished long-term survival, the U.S. Food and Drug Administration (FDA) issued a reminder warning to healthcare providers and the public in February 2019 that the technique has not been FDA approved for this purpose.

Initially approved in 2018, talazoparib (Talzenna^®) capsules are indicated for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene HER2-negative locally advanced or metastatic breast cancer.

On May 15, 2019, the U.S. Food and Drug Administration (FDA) approved venetoclax (Venclexta®) for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Nestled in the sleepy suburbs of Washington, DC, lies an influential agency that continues to have a growing impact on every American’s life. In fact, public opinion surveys indicate that the agency enjoys a broad range of support in the federal government and across the country in its work protecting people. Seen almost daily on the evening news, FDA encompasses a vast network of public health priorities important to many people’s daily lives. 

On May 14, 2019, the U.S. Food and Drug Administration (FDA) approved avelumab (Bavencio®) in combination with axitinib for first-line treatment of patients with advanced renal cell carcinoma.

U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, released a statement on March 28, 2019, about FDA’s new efforts to reduce tobacco-related disease and death through greater, far-reaching regulation on the tobacco industry. Coming on the heels of his announced departure from his role as of June 2019, the work would ensure his legacy as a staunch proponent of smoking cessation.

On May 3, 2019, the U.S. Food and Drug Administration (FDA) approved ado-trastuzumab emtansine (Kakcyla®) for the adjuvant treatment of patients with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.

On May 2, 2019, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo®) for newly-diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test, in patients who are at least 75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy.

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.

On April 19, 2019, the U.S. Food and Drug Administration (FDA) approved pembrolizumab plus axitinib for the first-line treatment of patients with advanced renal cell carcinoma.

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.

Ribociclib is a CDK 4/6 inhibitor first approved by the U.S. Food and Drug Administration in early 2017 for postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine therapy, based on the MONALEESA trial results. 

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.

Since their inception, e-cigarettes have made the public health sector uneasy. Initial reports suggested that e-cigarettes could be an opportunity for long-time adult smokers to step down their usage, acting as a bridge to smoking cessation. However, recent reports indicate that youth vaping and e-cigarette use has risen sharply in the past two years—creating an entirely new generation of smokers. U.S. Surgeon General Vice Admiral Jerome Adams, issued a statement declaring youth vaping a national epidemic.