FDA Reports Efficacy Issue for Patients Taking Pembrolizumab or Atezolizumab as Monotherapy to Treat Urothelial Cancer with Low Expression of PD-L1
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).
Huntington Disease May Hold Key to Novel Cancer Treatment
The mutated huntington (HTT) gene causes the body to generate a class of small molecules that are toxic to cancer cells but not most healthy cells, according to the results of a new study published in EMBO Reports. The researchers went as far as to call it a “super assassin against all tumor cells.”
Manage Diarrhea in Patients Receiving Nerlynx® (Neratinib) Tablets
Nerlynx® (neratinib) tablets, an oral kinase inhibitor, is approved by the U.S. Food and Drug Administration 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.
FDA Approves Tisagenlecleucel for Adults with Relapsed or Refractory Large B-Cell Lymphoma
On May 1, 2018, the U.S. Food and Drug Administration (FDA) approved tisagenlecleucel a CD19-directed genetically modified autologous T-cell immunotherapy, for 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, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma.
FDA Approves Dabrafenib Plus Trametinib for Adjuvant Treatment of Melanoma With BRAF V600E or V600K Mutations
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.
Biosimilars Offer New Options for Treatment and New Concepts for Patient Education
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.
FDA Approves Fostamatinib Tablets for ITP
On April 17, 2018, the U.S. Food and Drug Administration approved fostamatinib disodium hexahydrate tablets for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.
The Case of the Checkpoint Inhibitor Side Effects
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?
FDA Approves Nivolumab Plus Ipilimumab Combination for Renal Cell Carcinoma
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.
FDA Approves Everolimus for TSC-Associated Partial-Onset Seizures
On April 10, 2018, the U.S. Food and Drug Administration (FDA) approved everolimus tablets for oral suspension for the adjunctive treatment of adult and pediatric patients aged 2-years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures. Everolimus is also approved for two other manifestations of TSC: TSC-associated subependymal giant cell astrocytoma (SEGA) and TSC-associated renal angiomyolipoma.
Newly Approved Cancer Treatments Indicate Growing Role of Genomics and Oral Therapies
It is becoming more commonplace for nurses to find orders for agents with which they are unfamiliar or quite possibly have never administered. Following is a summary of the latest new U.S. Food and Drug Administration (FDA) approvals or indications to keep you up to date in your practice. Of note, this summary contains the approval of yet another biosimilar in trastuzumab-dkst and rolapitant for chemotherapy-induced nausea and vomiting, which includes a safety alert. Early experiences with rolapitant, a NK-1 inhibitor, indicated a risk of hypersensitivity reactions.
FDA Approves Nilotinib for Pediatric Patients With Chronic Phase Ph+ CML
On March 22, 2018, the U.S. Food and Drug Administration (FDA) approved nilotinib for pediatric patients 1 year of age or older with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior tyrosine-kinase inhibitor therapy.
FDA Approves Brentuximab Vedotin for Previously Untreated Stage III, IV Classical Hodgkin Lymphoma
On March 20, 2018, the U.S. Food and Drug Administration (FDA) approved brentuximab vedotin to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma in combination with chemotherapy.
What Oncology Nurses Need to Know About Pharmacogenomics
A subset of precision medicine, pharmacogenomics, is also growing exponentially, especially in oncology. Currently, 165 drugs or combinations are influenced by pharmacogenetics, and 58 of those are specific to oncology/hematology.
NCI Updates Cancer Trends Progress Report
The National Cancer Institute (NCI) has proactively shared new information and trends with the general public. Through its Cancer Trends Progress Report, NCI provides descriptions of research and data to help review past experiences and assist the agency in planning for future research funding.
Get an Overview of Radiation Therapy for Cancer
Radiation therapy is a precise cancer treatment that targets tumor cells specifically and spares healthy surrounding tissues. Contrary to pharmacologic treatment methodologies, side effects are predominantly site-specific.
FDA Approves Abemaciclib As Initial Therapy for HR-Positive, HER2-Negative Metastatic Breast Cancer
On February 26, 2018, the U.S. Food and Drug Administration (FDA) approved abemaciclib (Verzenio™) in combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 HER2-negative advanced or metastatic breast cancer.
FDA Approves Durvalumab After Chemoradiation for Unresectable Stage III NSCLC
On February 16, 2018, the U.S. Food and Drug Administration (FDA) approved durvalumab (Imfinzi) for patients with unresectable stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
FDA Approves Apalutamide for Nonmetastatic Castration-Resistant Prostate Cancer
On February 14, 2018, the U.S. Food and Drug Administration (FDA) approved apalutamide (Erleada) for patients with non-metastatic castration-resistant prostate cancer.
FDA Clears Genomic Profiling Tests for Cancer Treatment
Former National Institutes of Health (NIH) Director, Harold Varmus, when asked about cancer treatment, once said, “One of the major advances we’ve had as a result of cancer research is deep recognition of the complexity of cancer. It’s not one disease, it’s lots of different diseases. Every single cancer is different when you look at it on a genetic level.”
FDA Approves Lutetium Lu 177 Dotatate for Treatment of GEP-NETS
On January 26, 2018, the U.S. Food and Drug Administration (FDA) approved lutetium Lu 177 dotatate a radiolabeled somatostatin analog, for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults.
Immunotherapy Without Immune Cells May Be on the Horizon
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.
FDA Approves First Biosimilar for Cancer Treatment, Among Other New Immunotherapy Dosing and Indications
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.
Discovery of Peripheral Neuropathy Cause May Lead to Preventive Treatments
Researchers have found that taxane chemotherapies such as paclitaxel impede a protein called Bclw, which leads to the side effect of peripheral neuropathy. The study results were published in Neuron.
FDA Grants Accelerated Approval to Bosutinib for Treatment of Newly-Diagnosed PH+ CML
On December 19, 2017, the U.S. Food and Drug Administration granted accelerated approval to bosutinib for treatment of patients with newly-diagnosed chronic phase Philadelphia chromosome positive chronic myelogenous leukemia.
FDA Grants Regular Approval to Cabometyx for First-Line Treatment of Advanced Renal Cell Carcinoma
On December 19, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to cabozantinib for treatment of patients with advanced renal cell carcinoma (RCC).
Aggressive Treatment Needed for Locoregional Recurrence in Patients With Breast Cancer
Researchers from Memorial Sloan Kettering Cancer Center in New York, NY, suggested that for women with locoregional recurrence (LRR) of breast cancer, contralateral axillary metastases should be treated aggressively for cure after excluding distant metastases. Challenges of and best practices for managing LRR was discussed at an education session during the San Antonio Breast Cancer Symposium on Tuesday, December 5.
NCI Advancements Are Pushing Research Forward for Patients
Former U.S. Senator Arlen Specter (R-PA) put partisanship aside to support federal funding for biomedical research. And, while battling cancer himself, he spoke about the National Institutes of Health (NIH) and its crucial role in finding treatments and cures. “Health is our nation’s number one asset. Without your health, you can’t do anything. I believe medical research should be pursued with all possible haste to cure the diseases and maladies affecting Americans. I have said many times that the NIH is the crown jewel of the federal government—perhaps the only jewel of the federal government.”
FDA Approves Ogivri as a Biosimilar to Herceptin
On December 1, 2017, the U.S. Food and Drug Administration approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with HER2-overexpressing breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma).
FDA Approves Sunitinib Malate for Adjuvant Treatment of Renal Cell Carcinoma
On November 16, 2017, the U.S. Food and Drug Administration (FDA) approved sunitinib malate (Sutent, Pfizer Inc.) for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma following nephrectomy.
New Imaging Better Shows Immunotherapy Results in Brain Cancer
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.
What Oncology Nurses Need to Know About Subcutaneous Rituxan Hycela
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.
FDA Update on Nerlynx™ (Neratinib) Tablets
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.
FDA Approves Axicabtagene Ciloleucel for Large B-cell Lymphoma
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.
Women Respond Better to Esophageal Cancer Treatment
Women with locally advanced esophageal cancer that is treated with chemotherapy and radiation therapy before surgery are more likely to have a favorable response to their cancer treatment and less likely to have recurrence than men are, according to the results of a study published in Annals of Thoracic Surgery.
FDA Simplifies IRB Requirements for Individual Patient Expanded Access
On October 3, 2017, the U.S. Food and Drug Administration (FDA) announced updates to three final guidance documents, including Form FDA 3926 and its instructions, to simplify Institutional Review Board (IRB) review requirements for physicians seeking to treat an individual patient with an investigational drug under expanded access. The updates allow for a waiver of the requirement for review and approval at a convened IRB meeting if the physician instead obtains concurrence by the IRB chairperson (or a designated IRB member) before treatment use begins.
Recent Drug Approvals Offer New Options for Non-Small Cell Lung Cancer, Genitourinary Cancers, and More
Cancer treatment options continue to multiply as 2017 continues, with the U.S. Food and Drug Administration (FDA) granting multiple new drug approvals and broadening indications for others. Oncology clinicians and nurses are challenged with staying abreast of treatment option expansions and navigating the dynamic field of cancer treatment to effectively navigate their patients through the treatment trajectory, educating on vital points relative to treatment, minimizing morbidity and mortality, and optimizing quality of life. Following is an overview of the latest approvals for the second quarter of 2017.
FDA Grants Accelerated Approval to Nivolumab for HCC
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.
FDA Approves Lower Dose of Cabazitaxel for Prostate Cancer
On September 14, 2017, the U.S. Food and Drug Administration (FDA) approved a lower dose of cabazitaxel (20 mg/m2 every 3 weeks) in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen. Cabazitaxel (25 mg/m2 every 3 weeks) was approved for this indication in 2010.
FDA Grants Accelerated Approval to Copanlisib for Relapsed Follicular Lymphoma
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.
FDA Approves First Biosimilar for Cancer Treatment
On September 14, 2017, the U.S. Food and Drug Administration (FDA) approved Mvasi (bevacizumab-awwb, Amgen Inc.) as a biosimilar to Avastin (bevacizumab, Genentech Inc.). Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer.
Manage Adverse Events From Immunotherapy and Targeted Therapy for Melanoma
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.
Oncology Nurses Drive Change In Cancer Care With Clinical Trials
Clinical trials are responsible for discovering new treatments for cancer as well as the continued evolution of standards of care in clinical practice. Nationally, less than 5% of all eligible adult patients with cancer enroll in clinical trials. Additionally, it takes a drug an average of six to eight years from when it is first introduced in trials to become fully available to all patients who could benefit from it.
FDA Approves Gemtuzumab Ozogamicin for CD33-Positive AML
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.
FDA Halts Two Clinical Trials Evaluating Pembrolizumab in Patients With Multiple Myeloma
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.
FDA Approves Tisagenlecleucel for B-cell ALL, Tocilizumab for Cytokine Release Syndrome
On August 30, 2017, the U.S. Food and Drug Administration granted regular approval to tisagenlecleucel for the treatment of patients up to age 25 years with B-cell precursor acute lymphoblastic leukemia that is refractory or in second or later relapse.
FDA Approves Olaparib Tablets for Maintenance Treatment in Ovarian Cancer
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.