FDA Announces Bayer’s Voluntary Nationwide Recall of Larotrectinib Oral Solution 20 mg/ml
On November 21, 2023, the U.S. Food and Drug Administration (FDA) advised that Bayer issued a voluntary recall for one lot of larotrectinib (Vitrakvi®) oral solution 20 mg/ml in 100 ml glass bottles to the user level because of Penicillium brevicompactum microbial contamination observed during routine stability testing.
Advancements in Childhood Cancer Move Toward Personalized Treatments
Personalizing cancer treatments through targeted drugs and customized doses can make strides in care for pediatric patients with cancer, cancer specialists said in the National Institutes of Health's News in Health.
The Pharmacist’s Role in Combination Cancer Treatments
Since the first checkpoint inhibitor was approved in 2011, we have made tremendous leaps in immunotherapy in a short span of 10 years. Now we see immunotherapy combined with a variety of options, including chemotherapy or other oral and IV targeted therapy.
Defining Individual Biosignatures Through Precision Health Symptom Science Helps Nurses Deliver Even Better Care
Understanding the underlying mechanisms of cancerrelated symptoms enables oncology nurses to provide the best patient-centered care. Biosignatures are indicators of life, and in disease, they contribute to the determination of clinical profiles. Identifying specific biologic markers associated with similar patient characteristics and symptoms may help us create tailored interventions for improved symptom management.
Genetic Counselors Help Patients and Providers Understand Biomarker Testing Goals and Results
Genetic counselors have a unique ability to explain complex genetic information to patients, providers, and our healthcare colleagues and to empower patients to take an active role in their healthcare decisions. We review biosignature data points and help explain the difference between variants that were acquired (somatic) versus those that may have a germline component, or possibly inherited from a parent. By working with oncology teams, genetic counselors provide guidance on potential next steps to evaluate variation occurrences and how providers, patients, and their families can use the information to guide their care.
Bringing Biosignatures to the Bedside
With the growth of genomics and targeted therapy, nurse scientists are gaining deeper understanding the vast facets of patients’ symptom experience, and biosignatures could be the key to unlocking the next frontier in symptom science research.
HER2 Therapies May Be Effective in a Variety of Solid Tumors
Researchers have found that 2%–3% of all solid tumors overexpress or amplify HER2 protein that may be a target for drugs such as pertuzumab and trastuzumab, particularly in KRAS-variant disease. They presented their findings during the 2021 American Society of Clinical Oncology annual meeting.
The Case of the Mysterious Myalgia
Randi is a 57-year-old patient who identifies as female. She was diagnosed with clear cell metastatic renal cell carcinoma (mRCC), and her past medical history includes mild hypertension managed with amlodipine and a two-year history of transient musculoskeletal pain managed with tramadol. She reports a family history of cardiovascular disease and rheumatoid arthritis (RA). Her primary care physician suspects Randi is at the beginning stages of fibromyalgia but has not made a conclusive diagnosis because she hasn’t experienced additional symptoms.
Targeted Therapies Are Transforming the Treatment of Non-Small Cell Lung Cancer
Testing for molecular biomarkers has become a mainstay in determining treatment approaches for advanced-stage non-small cell lung cancer. Typically, next-generation sequencing identifies any potential genomic variants that are associated with oncogenic driver events and can be targeted with oral tyrosine kinase inhibitors.
Targeted Therapy Drug Shows Promise in CLL
Pirtobrutinib, an investigational, third-generation Bruton tyrosine kinase (BTK) inhibitor, offered response rates of 60% or higher in most groups of heavily pretreated patients with chronic lymphocytic leukemia (CLL), even those who’ve received other BTK inhibitors as previous treatment, researchers reported in Lancet.
Larotrectinib and Other Tumor-Agnostic Targeted Therapies Are Leading Cancer Care Into the Next Frontier
In 2018, the cancer drug larotrectinib quietly became a milestone along the evolving path to approaching cancer therapy: it was the first agent approved to treat a genetic variant, not a specific type of cancer or disease site. And as oncology treatment science progresses, many predict that it won’t be the last—it’s already been joined by pembrolizumab and entrectinib as tumor-agnostic therapies. The key to curing cancer may be hidden in the disease’s genetic code rather than its location in the body.
NKT Cells May Be the Next Wave of CAR Therapy
When genetically modified with a chimeric antigen receptor (CAR), natural killer T (NKT) cells eliminated 50% of metastases in a patient with heavily pretreated, relapsed or refractory metastatic neuroblastoma, according to interim findings from an ongoing study that were published in Nature Medicine.
Nurses Must Be Pharmacovigilant With Emerging Cancer Treatments
The field of cancer care is changing and evolving like never before. In 2018, the U.S. Food and Drug Administration (FDA) approved a number of new biosimilars, targeted agents, and agents that target certain mutations regardless of tumor site. New requirements for accreditation and reimbursement mean oncology nurses are being used in a growing number of new or developing roles including navigation and survivorship. On Thursday, April 11, 2019, Kathleen Wiley, RN, MSN, AOCNS®, addressed these emerging trends and more in a clinical chat at the ONS 44th Annual Congress in Anaheim, CA.
Microfluidic Device May Pave Way for More Liquid Cancer Biopsies
Researchers have developed a device that can separate various cell types in patient blood samples based on the cell size, which may one day enable rapid, inexpensive liquid biopsies to help clinicians detect cancer and develop targeted treatment plans. Findings from the research that led to the device are reported in Microsystems and Nanoengineering.
Biosimilars, Oral Agents, and Drugs Targeting Genetic Mutations Are Creating a Paradigm Shift in Cancer Treatment
New treatment options continue to emerge for diseases that until recently had limited, if any, treatment choices. Nurses are seeing more changes in the way treatment regimens come together, biosimilars are presenting viable options for patients, and genetic mutations, as opposed to disease sites, are at the forefront of drug development.
What Is the APRN’s Role in Managing Patients Receiving Targeted Therapy?
Targeted therapies block the growth of cancer by interfering with specific molecules and may also be referred to as molecularly targeted drugs or precision oncology. Advanced practice RNs (APRNs) must be familiar with the various agents and their side effect profiles, including immunotherapies, hormone therapies, apoptosis inducers, monoclonal antibodies, angiogenesis inhibitors, and signal transduction inhibitors.
Testing in the Era of Precision Oncology
Every cancer diagnosis is as individualized and unique as the person receiving it. From family history to societal and economic background to a patient’s genetic make-up and composition, cancer affects each person with cancer differently. Initiatives like precision medicine are based in data that suggest that a personalized disease should have its own personalized treatment. As a subset of precision medicine, precision oncology assesses a patient’s unique genetic profile to help align targeted therapies to hit the right cancer subtypes.
Oncology Drug Reference Sheet: Ribociclib
Ribociclib is a CDK 4/6 inhibitor first approved by the U.S. Food and Drug Administration in early 2017 for postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine therapy, based on the MONALEESA trial results.
Oral Adherence With Nerlynx® (Neratinib) Tablets: Patient Case
AS is a 58-year-old woman who was diagnosed at age 55 with a right infiltrating ductal carcinoma of the breast, identified as grade III, ER and PR positive, and HER2 positive. She had bilateral mastectomy, and tumor size was noted to be 2.8 cm. She had a positive sentinel lymph node. She was staged at IIB (pT2, pN1, M0). Her left breast was noted to have usual ductal epithelial hyperplasia and a 1.2 cm fibroadenoma. AS’s genetic testing revealed a BRCA1 mutation (BRCA1 c.3748G>T [p.Glu1250*]), which may confer an increased risk for breast cancer in the range of 46%–87%, and 39%–63% risk for ovarian cancer by age 70. As her patient history shows, she has some risk factors for nonadherence, including no support at home and some financial issues. Throughout her care, the team worked to communicate and prepare AS to help ensure adherence as much as possible.
Oral Adherence With Nerlynx® (Neratinib) Tablets: Introduction
The cancer treatment landscape has shifted with the emergence of new, targeted therapies. Development and use of oral oncolytics, targeted cancer therapies that can be taken by patients orally in their own homes, has increased in recent years. This increase is due in part to research in extra- and intracellular signaling pathways. By interfering with or blocking these signals, targeted drugs have become standard agents in cancer therapy. Oral oncolytics currently account for about 25% of the oncology pipeline of drugs in clinical development, and experts project that oral oncoloytic use will continue to rise.
An Oncology Nurse’s Guide to Targeted Therapy
Whereas chemotherapy induces apoptosis by interfering with cell division of both cancerous and healthy cells, targeted therapy exploits targets, proteins, enzymes, or genes specific to malignant cells through a variety of mechanisms of action, which helps prevent drug resistance. The agents work by either inhibiting angiogenesis, blocking chemical signals that tell cells to divide or carry out normal function, or delivering toxic substances to a cell.
Which Breast Cancers Benefit from Treatment With Cyclin-Dependent Kinase 4/6 Inhibitor Treatment?
Which Breast Cancers Benefit from Treatment With Cyclin-Dependent Kinase 4/6 Inhibitor Treatment?
A. Newly diagnosed DCIS
B. Metastatic, triple negative
C. Premenopausal, neoadjavant
D. ER+ metastatic
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.
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.
FDA Approves Alectinib for ALK-Positive, Advanced, Metastatic NSCLC
On November 6, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to alectinib (Alecensa) for treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.
New Blood Test Paves Way for Targeted Treatment for Prostate Cancer
A new three-in-one blood test that analyzes cancer DNA in the bloodstream before and during treatment will allow providers to understand and track which patients are likely to benefit from treatment with olaparib, a PARP inhibitor. Additionally, researchers found which genetic mutations prostate cancers use to resist treatment with olaparib. The study was published in Cancer Discovery.
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.
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.
Understanding Precision Medicine Therapeutics
Precision medicine involves the identification of actionable mutations and agents that target those specific pathways. ONS member Debra Wujcik, PhD, RN, FAAN, the director of research at Carevive Systems, Inc., gave an overview of precision medicine therapies at the Oncology Nurse Advisor Navigation Summit.
Ibrutinib May Improve GVHD Symptoms
Results from a new clinical trial have shown that the targeted therapy drug ibrutinib, a BTK inhibitor, can effectively treat graft-versus-host disease (GVHD), a common complication from allogeneic stem cell transplants. The study findings were reported at the American Society of Hematology’s 2016 annual meeting.
Do You Know the Best Practices for Targeted Medication Safety?
The Institute for Safe Medication Practices (ISMP) has added five new best practices and revised two existing ones for safe medication administration in its recent release of the 2016-2017 Targeted Medication Safety Best Practices for Hospitals.