FDA Approves Dabrafenib and Trametinib Combination for Metastatic NSCLC with BRAF V600E Mutation
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.
FDA Approves Rituximab Plus Hyaluronidase Combination for Treatment of FL, DLBCL, and CLL
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.
Combination Treatment Improves Survival for Advanced Melanoma
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.
Recent FDA Approvals Continue to Focus on Targeted and Immunotherapy
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.
Members Meet to Lead ONS Into the Future
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.
Cultivate Your Immunotherapy Education With ONS Resources
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.
Patient-Provider Communication on Immunotherapy Can Be Improved
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.
Study Assesses Response to Pembrolizumab Based on Biomarkers in Patients With Soft Tissue or Bone Sarcomas
The multicenter, phase II SAR028 clinical trial was the first to study pembrolizumab monotherapy in patients with soft tissue sarcoma or bone sarcoma to assess the clinical efficacy signals in multiple histologies. The researchers presented extended follow-up data at the ASCO Annual Meeting.
How the Evolution of Immunotherapy Will Impact Oncology Nurses
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.
FDA Broadens Ceritinib Indication to Previously Untreated ALK-Positive Metastatic NSCLC
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.
Gene-Editing Tool May Better Deliver CAR T-Cell Immunotherapy
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.
FDA Grants Accelerated Approval to Pembrolizumab for First Tissue/Site Agnostic Indication
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.
FDA Grants Approval to Pembrolizumab for Locally Advanced or Metastatic Urothelial Carcinoma
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.
The Challenge of Caring for Multiple Patients With Cancer
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.
FDA Grants Accelerated Approval to Pembrolizumab in Combination With Pemetrexed and Carboplatin for Treatment of Metastatic Non-Squamous NSCLC
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.
FDA Grants Accelerated Approval to Avelumab for Urothelial Carcinoma
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.
Nursing Considerations for Adverse Events From CAR T-Cell Therapy
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.
How Oncology Nurses Can Contribute to Immunotherapy Clinical Trials
Using the human immune system to target cancer has made tremendous strides in recent years. Jaruska Naidoo, MBBCh, from the Sidney Kimmel Comprehensive Cancer Center, and Joanne Riemer, RN, BSN, from Johns Hopkins University, discussed the progress made in immunotherapy and how nurses play a role in clinical trials during a session at the 42nd Annual Congress in Denver, CO.
Handoff Tool Promotes Nurse-to-Nurse Communication to Avoid Patient Adverse Events
RuthAnn Gordon, MSN,FNP-BC, OCN®, from Memorial Sloan-Kettering Cancer Center in New York, and co-authors presented the findings during a poster session at the ONS 42nd Annual Congress in Denver, CO. The poster was titled “Utilizing Nurse to Nurse Handoff Communication to Manage Immune Related Adverse Events in an Outpatient Immunotherapy Clinic.”
Opening Session Gives Voice to Cancer Survivor and Notes How Nurses Are an Important Part of Care
The opening session at the 42nd Annual Congress in Denver, CO, was a lively one, featuring a talk from ONS President Susan Schneider, PhD, RN, AOCN®, FAAN, recognition of the 2017 ONS award recipients, and a discussion from ONS Foundation President Deborah K. Walker, DNP, FNP-BC, NP-C, AOCN®, who talked about the Foundation’s goal of raising $130,000 at Congress, with $80,000 in donations already in the books. Schneider also commented that the 2017 Annual Congress has more than 4,000 attendees, which is the most the meeting has seen in a decade.
FDA Approves Durvalumab for Urothelial Carcinoma Treatment
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.
FDA Grants Accelerated Approval to Brigatinib for ALK-Positive NSCLC
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.
FDA Expands Regorafenib Indications for Patients with HCC
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.
The Case of the Immunotherapy Inquiry
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.
What Oncology Nurses Need to Know About Immunotherapy Agents
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.
FDA Broadens Palbociclib Indication in Breast Cancer
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.
FDA Grants Regular Approval to Osimertinib for EGFR T790 Mutation-Positive NSCLC
On March 30, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to osimertinib for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.
Recent FDA-Approved Drugs Offer More Options for NSCLC and Other Cancers
The end of 2016 proved to be a busy and exciting time for cancer breakthroughs, seeing eight new U.S. Food and Drug Administration (FDA) approvals for immunotherapy and biotherapy. Following is a summary of cancer-related FDA approvals in the last quarter of 2016, indications for treatment, and associated clinical implications.
FDA Approves Niraparib for Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
On March 27, 2017, the U.S. Food and Drug Administration (FDA) approved niraparib, a poly ADP-ribose polymerase (PARP) inhibitor, for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.
FDA Approves Avelumab for Treatment of Patients With Metastatic Merkel Cell Carcinoma
On March 23, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to avelumab (Bavencio, EMD Serono, Inc.) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). Avelumab is a programmed death-ligand 1 (PD-L1) blocking human IgG1 lambda monoclonal antibody. This is the first FDA-approved product to treat this type of cancer.
FDA Approves Pembrolizumab for Refractory or Relapsed Classical Hodgkin Lymphoma
On March 14, 2017, The U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA®, Merck and Co., Inc.) for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or those who have relapsed after three or more prior lines of therapy.
FDA Approves Ribociclib for Breast Cancer Treatment
On March 13, 2017, the U.S. Food and Drug Administration (FDA) approved ribociclib (KISQALI®, Novartis Pharmaceuticals Corp.), a cyclin-dependent kinase 4/6 inhibitor, in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
FDA Approves Lenalidomide as Maintenance Therapy for Patients With Multiple Myeloma
On February 22, 2017, the U.S. Food and Drug Administration (FDA) approved lenalidomide (Revlimid®, Celgene Corp.) as maintenance therapy for patients with multiple myeloma following autologous stem cell transplant.
Advancements in Immunotherapy, Genetics Lead ASCO’s Annual Progress Report
Every year, oncology research marches toward new, innovative treatments for patients with cancer. Cancer research is a cumulative process—building upon itself year after year—but, with time, major changes begin to make their way into practices across the country. Some of these advancements stand to change the face of cancer treatment for years to come. In a field of constant evolution, oncology nurses and their colleagues need to stay abreast of developments in science and technology as new knowledge is uncovered in the treatment of cancer.
FDA Approves Nivolumab for Advanced or Metastatic Bladder Cancer
On February 2, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with a platinum-containing chemotherapy.