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.

In June 2017, the U.S. Food and Drug Administration (FDA) approved Rituxan Hycela, a combination of rituximab and hyaluronidase, for subcutaneous administration in the treatment of follicular lymphoma and diffuse large B-cell lymphoma as well as chronic lymphocytic leukemia (CLL). This agent affords the same clinical benefit as IV rituximab, but in much less time. With this approval comes many questions about which patients are appropriate and administration considerations for subcutaneous rituximab and hyaluronidase.

On July 17, 2017, the U.S. Food and Drug Administration (FDA) approved Nerlynx™ (neratinib) tablets, an oral kinase inhibitor, for the extended adjuvant treatment of adult patients with early-stage human epidermal growth factor receptor 2-positive (HER2+) breast cancer, following adjuvant trastuzumab-based therapy.

On October 18, 2017, the Food and Drug Administration (FDA) granted regular approval to axicabtagene ciloleucel (Yescarta™) for the treatment of 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, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

On September 28, 2017, the U.S. Food and Drug Administration approved abemaciclib in combination with fulvestrant for women with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.

On September 22, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab for the treatment of hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib.

On September 22, 2017, the U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (Ketruda^®) for patients with recurrent locally advanced or metastatic, gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 as determined by an FDA-approved test. Patients must have had disease progression on or after two or more prior systemic therapies, including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, HER2/neu-targeted therapy.

A new study testing a dendritic cell vaccine for the first time in humans to treat non-small cell lung cancer (NSCLC) has shown that it successfully amplifies the immune system to boost the effectiveness of anti-PD-1 immunotherapies against the cancer. The findings were published in Clinical Cancer Research.

On September 14, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to copanlisib for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies.

New targeted and immunotherapy drug approvals have offered improved survival and disease outcomes for patients with melanoma, but the new therapies are also associated with a range of adverse events (AEs) that differ from those associated with chemotherapy. Oncology nurses will need to shift their thinking to best manage those AEs.

On September 1, 2017, the U.S. Food and Drug Administration (FDA) approved gemtuzumab ozogamicin (Mylotarg, Pfizer Inc.) for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and for treatment of relapsed or refractory CD33-positive AML in adults and in pediatric patients 2 years and older. Gemtuzumab ozogamicin may be used in combination with daunorubicin and cytarabine for adults with newly-diagnosed AML, or as a stand-alone treatment for certain adult and pediatric patients.

On August 31, 2017, based on data from two recently halted clinical trials, the U.S. Food and Drug Administration (FDA) is issuing a statement to inform the public, healthcare professionals, and oncology clinical investigators about the risks associated with the use of Keytruda (pembrolizumab) in combination with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) for the treatment of patients with multiple myeloma. Keytruda (pembrolizumab) is not approved for treatment of multiple myeloma.

On August 17, 2017, the U.S. Food and Drug Administration granted regular approval to olaparib tablets for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy.

On Aug. 17, 2017, the U.S. Food and Drug Administration approved inotuzumab ozogamicin for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

On August 2, 2017, the U.S. Food and Drug Administration (FDA) approved ibrutinib (Imbruvica^®, Pharmacyclics LLC) for the treatment of adult patients with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy. This is the first FDA-approved therapy for the treatment of cGVHD.

On August 1, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to enasidenib for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.

August marks the beginning of National Immunization Awareness Month, which is an annual observance to promote awareness of the importance of vaccination for individuals of all ages. It’s a great time for nurses to check with their patients and make sure they’re up to date on the recommended vaccines.

On July 31, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab for the treatment of patients 12 years and older with mismatch repair deficient and microsatellite instability high metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

Advanced practice oncology nurses know how complex the care of patients with cancer can be. Every day seems to bring further advancements in the treatment and management of cancer. It can be difficult to keep up with the onslaught of new information, but our patients rely on us to bring them the latest, greatest, and safest treatment options available.

Guidelines regarding healthcare provider communication about immunotherapy do not currently exist. Researchers sought to determine patient and provider preferences for this type of information and to identify barriers to communication about immunotherapy. The study’s findings were presented at the 2017 ASCO Annual Meeting.

You may remember Jay, a 62-year-old man with inoperable stage IIIA non-small cell lung cancer (NSCLC), from the case study in the April 2017 issue of ONS Voice. He was symptomatic with a persistent cough, unintentional weight loss, and fatigue.

On June 29, 2017, the U.S. Food and Drug Administration (FDA) granted marketing approval to the Praxis Extended RAS Panel (Illumina, Inc.), a next generation sequencing (NGS) test to detect certain genetic mutations in RAS genes in tumor samples of patients with metastatic colorectal cancer (mCRC). The test is used to aid in the identification of patients who may be eligible for treatment with panitumumab (Vectibix^®, Amgen, Inc.).

In a supplement to the April 2017 issue of the Clinical Journal of Oncology Nursing, ONS released its first set of recommendations for nurse education and safe handling principles regarding immunotherapy administration. ONS recommendations are based on best-available evidence and the anecdotal experiences of professionals at cancer centers with varied experiences in immunotherapy administration.

On June 22, 2017, the U.S. Food and Drug Administration granted (FDA) regular approvals to dabrafenib and trametinib (Taflinar^® and Mekinist^®, Novartis Pharmaceuticals Inc.) administered in combination for patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test.

On June 22, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to the combination of rituximab and hyaluronidase human (Rituxan Hycela, Genentech Inc.) for adult patients with follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia.

A combination of nivolumab and ipilimumab improved overall survival when compared to either drug alone, according to results from a recent study reported at the American Association for Cancer Research 2017 annual meeting.

Oncology clinicians can expect to continue to see new targeted and immunotherapy drugs emerge as clinically approved agents in the fight against cancer. Five cancer-related U.S. Food and Drug Administration (FDA) approvals occurred in the first quarter of 2017; following are their indications for treatment and associated clinical implications. You’ll recognize that some of the agents were already FDA approved for other uses, but as clinical trials continue and new data emerge, clinical use is expanding to other disease sites and indications.

As Oncology Nursing Month, May saw celebrations at the ONS 42nd Annual Congress and in our workplaces. Nurses on ONS staff enjoyed recognition and celebration of their commitment to our mission and you. They partner closely with members who volunteer their time and expertise in developing initiatives and priorities for ONS. I would like to describe a few of those initiatives and work groups that have met at the national office in the first six months of 2017.

Cancer centers across the country, especially those in larger medical centers, are seeing many immunotherapy agents in standard care now. Patients are hearing about advancements in immunotherapies, they’re excited by the possibilities, and the U.S. Food and Drug Administration is approving new drugs or indications almost every month. Although many patients still don’t recognize the distinction between standard treatment options and immunotherapy, it’s vital for nurses to stay educated and understand how these treatments work differently from traditional care options.

Immunotherapy is one of the fastest-evolving areas of oncology to date. Previously, it could take years for some cancers to see new treatment options; today, the U.S. Food and Drug Administration is approving new immuno-oncology agents or new indications for those agents every few weeks. It’s a boon and a challenge to medical professionals. On the one hand, potentially life-changing treatments are making way to patients who need them—patients who have exhausted first-line treatments and now have limited options. On the other hand, healthcare professionals may struggle to stay current with the emerging trends, cutting-edge science, and evolving treatment plans for their patients.

On May 26, 2017, the U.S. Food and Drug Administration granted regular approval to ceritinib (Zykadia^®, Novartis Pharmaceuticals Corp.) for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.

In mouse experiments, researchers have found that immune T cells that have been genetically engineered to express chimeric antigen receptors (CARs) using a new tool called CRISPR were more effective than CAR T cells that were engineered with conventional methods. The findings were reported in Nature.

On May 23, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda^®, Merck & Co.) for adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options or with MSI-H or dMMR colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

On May 18, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to pembrolizumab (Keytruda^®, Merck and Co., Inc.) for patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

As more new treatments enter practice—like immunotherapy, targeted therapy, and combination therapies—oncology nurses are required to be experts in every treatment they administer. They need to constantly walk a tightrope, balancing multiple medications for one patient then quickly moving to the next patient on a completely different treatment protocol.

On May 10, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab in combination with pemetrexed and carboplatin for the treatment of patients with previously untreated metastatic non-squamous non-small cell lung cancer.

On May 9, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to avelumab for patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

Chimeric antigen receptor (CAR) T-cell therapy offers options for pediatric patients with relapsed or refractory acute lymphoblastic leukemia, but it comes with a unique set of side effects that can range from mild to severe. As the primary patient providers, oncology nurses are often the first to identify signs and symptoms of adverse events and acute changes in patients’ status. Understanding what to watch for can improve outcomes and help nurses deliver safe, effective care.

On May 1, 2017, the U.S. Food and Drug Administration granted accelerated approval to durvalumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.  

On April 28, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to brigatinib for the treatment of patients with metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.

On April 27, 2017, the U.S. Food and Drug Administration (FDA) expanded the indications of regorafenib to include the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

Jay is a 62-year-old man with newly diagnosed, stage IIIA (T3, N1), unresectable, non-small cell lung cancer (NSCLC) that tested negative for ALK, EGFR, and KRAS mutations. Additionally, PD-L1 (programed death receptor ligand) expression was less than 30%. Jay is symptomatic with a persistent cough, unintentional weight loss, and fatigue.

As immunotherapeutic options for cancer treatments continue to grow, oncology nurses need a deeper understanding of the therapies, how they work, and how to manage their side effects, so they can continue to provide the best patient care.

On March 31, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to palbociclib for the treatment of hormone receptor (HR)‑positive, human epidermal growth factor receptor 2 (HER2)‑negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women.