On November 21, 2019, the U.S. Food and Drug Administration (FDA) approved acalabrutinib (Calquence®) for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Tobacco products are under more scrutiny than ever before. With the rise in youth vaping, the advent of flavored e-cigarettes, and the production of other nicotine delivery systems, the U.S. Food and Drug Administration (FDA) has tightened its review process for new products. The agency is looking to the smoking cessation community, taking insight from the Trump administration, and weighing feedback from other elected officials in the Senate and House of Representatives for ways to protect public health. That said, companies are using technology to create new tobacco-based products, and FDA must find ways to assess harm while balancing free market interests.

On November 14, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to zanubrutinib (Brukinsa™) for adult patients with mantle cell lymphoma who have received at least one prior therapy.

Ned Sharpless, MD, an oncologist by training, has had a year of transitions. He began his Washington career as the National Cancer Institute director in 2017, but after two years at the helm, he was tapped to be acting U.S. Food and Drug Administration (FDA) commissioner when Scott Gottlieb stepped down in March 2019. However, after heated discussions with the Senate over the perceived lack of action from FDA regarding restrictions to vaping and tobacco products, the Trump administration likely reconsidered his role at FDA and sought to find a more permanent appointee.

On October 23, 2019, the U.S. Food and Drug Administration (FDA) approved niraparib (Zejula®) for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD)-positive status. HRD is defined by either a deleterious or suspected deleterious BRCA mutation, or genomic instability in patients with disease progression greater than six months after response to the last platinum-based chemotherapy.

A manufacturing delay leading to a shipping delay caused the October 2019 vincristine shortage, according to a letter Pfizer sent to its customers on October 18; the U.S. Food and Drug Administration first reported the shortage on October 16. It affects both the 1 mg/ml and 2 mg/2 ml single-dose ONCO-TAIN™ glass fliptop vials.

Based on the results of the phase III ARAMIS trial that demonstrated significant improvement in metastasis-free survival, the U.S. Food and Drug Administration approved darolutamide under priority review on July 30, 2019. Darolutamide is approved for nonmetastatic, castration-resistant prostate cancer in men receiving concurrent gonadotropin-releasing hormone therapy or who have had bilateral orchiectomy.

Vaping has been associated with significant public health effects during the past several months, according to the Centers for Disease Control and Prevention. Congress is making e-cigarette regulation a top priority—especially in the wake of the youth smoking epidemic. Now, several members of Congress have developed their own legislative efforts to address the national issue.

On September 26, 2019, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex^®) for adult patients with multiple myeloma in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant.

Pembrolizumab, lenalidomide, and avelumab all received new treatment indications in spring 2019. Here’s what you need to know about dosing, adverse events, and other nursing considerations for these and other drugs that the U.S. Food and Drug Administration (FDA) approved from April–June 2019.

Erdafitinib (Balversa™) is the first targeted therapy that the U.S. Food and Drug Administration approved for treatment of metastatic bladder cancer. 

On September 17, 2019, the U.S. Food and Drug Administration (FDA) approved apalutamide (Erleada^TM) for patients with metastatic castration-sensitive prostate cancer. Apalutamide was initially approved in 2018 for patients with non-metastatic castration-resistant prostate cancer.

On September 17, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the combination of pembrolizumab (Keytruda^®) plus lenvatinib (Lenvima^®) for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation.

With more deaths reported from vaping and a forceful U.S. Senate declaration to the U.S. Food and Drug Administration (FDA) acting commissioner to either enact stronger federal provisions restricting e-cigarettes, flavored tobacco, and inhalants or resign, the Trump administration moved quickly to demonstrate a recognition that cessation is a national, bipartisan concern. FDA sent a warning letter to Juul about its marketing and labeling, and the president, Health and Human Services secretary, and FDA commissioner issued very public statements on the matter, making it clear that federal oversight will be enforced on youth tobacco issues.

Palbociclib (Ibrance), ribociclib (Kisqali), and abemaciclib (Verzenio) used to treat some patients with advanced breast cancers may cause rare but severe inflammation of the lungs, the U.S. Food and Drug Administration (FDA) announced on September 13, 2019. It approved new warnings about the risk on the prescribing information and package insert for the entire class of cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor medicines. However, “the overall benefit of CDK 4/6 inhibitors is still greater than the risks when used as prescribed,” the agency noted.

Chicago ONS Chapter member Janice Phillips, RN, CENP, PhD, FAAN, said it all in her op-ed published on Morning Consult. The entire Democratic field of presidential candidates has declared some form of healthcare overhaul, albeit to varying degrees of change. With expanded access and reduced costs for patients and families as a priority, the centerpiece to most presidential hopefuls’ domestic policy program is redesigning a struggling system.

On September 3, 2019, AmEx Pharmacy issued a voluntary recall of two dosages of injectable bevacizumab. Although injectable bevacizumab is used in cancer treatment, the formulations affected by the recall are for much smaller dosages that are used to treat eye diseases (i.e., macular degeneration and diabetic retinopathy).

As the youth smoking epidemic persists and illnesses related to vaping make the headlines, the U.S. Food and Drug Administration (FDA) is searching for solutions to combat the growing impact of new tobacco and nicotine products. After weeks of public outcry, FDA has doubled down on its regulatory stance, issuing several statements—including new warning letters to large tobacco companies—to reinforce its commitment to aggressive oversight and regulation of new tobacco products.

Venetoclax (Venclexta^®) was approved by the U.S. Food and Drug Administration on May 15, 2019, for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) as a single agent or in combination therapy. Previously, it had been approved in late 2018 for use in combination therapy for acute myeloid leukemia (AML) in older adults or those with significant comorbidities.

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.