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.

Researchers have found a significant difference in overall survival in men versus women receiving immune checkpoint inhibitors for advanced cancers. The findings from the systematic review and meta-analysis were reported in Lancet Oncology.

Although immunotherapy is changing the face of cancer care, it’s not exempt from side effects. As researchers and clinicians work to understand immune-related adverse events and how to manage them, a new challenge is emerging: reporting and grading them to get an accurate grasp on incidence rates and to standardize care to ensure better outcomes for patients. The Common Terminology Criteria for Adverse Events (CTCAE) is one tool that’s helping researchers and bedside nurses do just that. 

Ibrutinib is a first-in-class Bruton’s tyrosine kinase inhibitor that is approved by the U.S. Food and Drug Administration to treat chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). The drug’s approval was based on results from the multicenter, open-label, phase III RESONATE trial.

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.

A combination of immunotherapies may increase the formation of memory T cells and lead to a more lasting response, according to findings from a study presented at the American Association for Cancer Research’s 2018 annual meeting.

Mrs. Jones is a 66-year-old postmenopausal woman who developed left breast pain and a palpable mass. A mammogram and ultrasound showed a 4.6 cm mass with an enlarged axillary node. A core biopsy revealed invasive ductal carcinoma that is estrogen receptor positive, progesterone receptor positive, and HER2 negative. Positron-emission tomography and computed tomography scans revealed metastatic disease.

Combining pembrolizumab and platinum chemotherapy plus pemetrexed doubles survival in patients with nonsquamous non-small cell lung cancer (NSNSCLC) without EGFR or ALK gene mutations, according to the results of a study published in the New England Journal of Medicine.

Immunotherapy drugs fall into varying classes, each carrying its own mechanism of action and anticipated side effects. Although some side effects of immunotherapy may appear similar to those of chemotherapy (e.g., diarrhea, fatigue), they actually result from a totally different mechanism—meaning they require a different approach to management. Treating immunotherapy side effects as you would chemotherapy effects would likely result in patient harm.

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).

After decades of no new treatment options for advanced melanoma, several drugs for unresectable stage III and IV disease and recurrent melanoma have been approved, including newer classes of drugs such as checkpoint inhibitors (anti-PD-1 and anti-CTLA-4 drugs) and signal transduction inhibitors (BRAF, MEK, and KIT inhibitors). Advanced practice registered nurses (APRNs) must be familiar with these newer agents and classes of drugs, especially the mutations that guide their use.

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.

The list of pharmacologic agents used in cancer care is expanding: chemotherapy, biotherapy, immunotherapy, targeted therapy, hormonal therapy, and now biosimilars. Part of being a nurse leader is recognizing trends in cancer care, changes on the horizon, and their impact on your patients and cancer treatment options. Biosimilars represent one such trend that affects providers’ approach to care and the education that oncology nurses must provide to patients and caregivers.

John is a 62-year-old man diagnosed with metastatic non-small cell lung cancer (NSCLC). His tumor tested positive for high PD-L1 expression, and he began pembrolizumab treatment. John presents to the clinic for his third treatment and mentions that during the past week his arms and chest have been itchy and he has noticed a red, bumpy rash on his chest. When assessing John’s skin, you note a maculopapular rash on both of his upper extremities, anterior chest, and upper abdomen. What would you do?

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 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.

New guidelines and consensus recommendations for managing immune-related adverse events (irAEs) from checkpoint inhibitors are available from several key cancer and immunotherapy organizations: a collaboration between the American Society of Clinical Oncology and National Comprehensive Cancer Network, and a separate consensus recommendation from the Society for Immunotherapy of Cancer. ONS contributed to the development of both sets of guidelines.

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%.

Because the treatment of symptoms, side effects, and adverse events associated with immunotherapies can differ greatly from the standard of care, the American Society of Clinical Oncology (ASCO) and National Comprehensive Cancer Network (NCCN)—along with experts from ONS staff and membership—collaborated to develop guidelines to inform clinicians about managing immune-related adverse events associated with checkpoint inhibitor therapy.

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.

Researchers have generated immunotherapy in the laboratory using nonimmune cells. If the findings can be translated into treatment, it may reduce some of the immune-related adverse events that patients experience with today’s cancer immunotherapy treatments. The study was reported in Nature Chemical Biology.

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 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).

Researchers have developed a new approach for brain imaging that can better distinguish immune responses from tumor growth in people with glioblastoma. The findings were published in Proceedings of the National Academy of Sciences.

Mary, age 60, has been diagnosed with stage IIB ovarian cancer. Because she has a strong family history of various cancers, Mary is tested for Lynch syndrome, also known as hereditary nonpolyposis colorectal cancer (HNPCC).

Her test is positive, and she is told she is at increased risk for developing cancers associated with HNPCC: ovarian, breast, prostate, kidney, endometrial, pancreatic, prostate, and liver.

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 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.

Chimeric antigen receptor (CAR) T-cell therapy for relapsed or chemotherapy-resistant acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia, and B-cell lymphomas is becoming more common. The benefit to patients is significant: durable remission and increased comfort are two major advantages. However, severe toxicities are associated with CAR T-cell therapy that must be considered. As with any treatment modality, the best approach to management for an advanced practice oncology nurse is to fully understand those toxicities and be prepared to provide intensive supportive care.

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.