FDA Approves Cabozantinib for Differentiated Thyroid Cancer
On September 17, 2021, the U.S. Food and Drug Administration (FDA) approved cabozantinib (Cabometyx®) for adult and pediatric patients aged 12 years and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior vascular endothelial growth factor (VEGFR)-targeted therapy and who are ineligible for or refractory to radioactive iodine treatment.
The Case of the Triple-Negative Breast Cancer Targeted Treatment
Ophelia is a 42-year-old patient who has been diagnosed with triple-negative breast cancer (TNBC). She completed neoadjuvant chemotherapy with dose-dense doxorubicin and cyclophosphamide, followed by paclitaxel and carboplatin. Her postsurgical pathology shows residual disease in the tumor (3.5 cm down from 4 cm) and 12 out of 18 lymph nodes that are positive for cancer. Ophelia tells you that she is very discouraged and expected a better treatment outcome.
Oncology Drug Reference Sheet: Tepotinib
Tepotinib (Tepmetko®) was granted accelerated approval in February 2021 for mesenchymalepithelial transition (MET)-altered metastatic non-small cell lung cancer (NSCLC) based on overall response rate and duration. The drug is still under long-term evaluation and healthcare providers should report all serious adverse events that may be associated to FDA’s MedWatch Reporting System.
Imaging Test Identifies Treatment Choices for ER-Positive Breast Cancer
Using positron-emission tomography with a radioactive tracer identifies levels of progesterone receptor in patients with estrogen receptor-positive breast cancer, researchers reported in Nature Communications. The diagnostic tool would help clinicians determine which patients are most likely to respond to hormone therapies for breast cancer.
Oncology Drug Reference Sheet: Trilaciclib
On February 12, 2021, the U.S. Food and Drug Administration approved trilaciclib (CoselaTM), a parenteral inhibitor of cyclin-dependent kinase, to prevent myelosuppression when administered prior to chemotherapy administration. The approval is currently limited to the use of trilaciclib before treatment with platinum- and etoposide-containing regimens and topotecan-containing regimens for treatment of extensive-stage small cell lung cancer.
FDA Approves Nivolumab for Resected Esophageal or GEJ Cancer
On May 20, 2021, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo®) for patients with completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease who have received neoadjuvant chemoradiotherapy.
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.
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.
The Horizon Looks Promising for Emerging Radiation Therapies in Oncology Care
Cutting-edge advancements in radiation therapy (RT) may allow oncology practitioners to only target the current tumor and avoid damaging healthy tissue. During a session on April 29, 2021, at the ONS 46th Annual Congress, W. Neil Duggar, PhD, DABR, of the University of Mississippi Medical Center, provided an overview of RT from a medical physics perspective, with a focus on how developing technologies may revolutionize care for patients with cancer.
Radiopharmaceuticals Pack a One-Two Punch Against Cancer
Radionuclides, also called radioisotopes, are unstable chemical elements that release radiation as they break down, and that action can be combined with cancer drugs to fight tumors with a new punch. During a session on April 27, 2021, for the 46th Annual ONS Congress, Pam Grubbs, APRN, CNS, MS, AOCNS®, of Mayo Clinic in Rochester, MN, discussed how oncology is using radiopharmaceuticals in a variety of ways.
FDA Grants Accelerated Approval to Loncastuximab Tesirine-Lpyl for Large B-Cell Lymphoma
On April 23, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to loncastuximab tesirine-lpyl (Zynlonta™), a CD19-directed antibody and alkylating agent conjugate, for adult patients with relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma, after two or more lines of systemic therapy.
Oncology Nurses Navigate the Changing Landscape of Immuno-Oncology
Immune checkpoint inhibitors (ICPIs) enhance treatment response while minimizing toxicities for patients with cancer. However, education is key to managing the therapies’ unique adverse events (AEs). During a session for the ONS 46th Annual Congress™, Marianne Davies, DNP, ACNP, FAAN, of the Yale Comprehensive Cancer Center, Smilow Cancer Hospital at Yale New Haven Hospital, and the Yale University School of Nursing, and Laura S. Wood, RN, MSN, OCN®, of Cleveland Clinic Cancer Center, provided oncology nurses with a foundation for evaluating and grading AEs in immuno-oncology.
Building a CAR T-Cell Program: How to Go From None to Done
Chimeric antigen receptor (CAR) T-cell therapy is a promising new treatment option for patients with certain types of cancer. As the field expands, institutions are exploring specialized service lines to provide the treatment, speakers said during a presentation on April 22, 2021, for the 46th Annual ONS Congress™ as they shared the lessons learned as their institutions established CAR T-cell therapy programs.
FDA Approves Nivolumab in Combination With Chemotherapy for Metastatic Gastric Cancer and Esophageal Adenocarcinoma
On April 16, 2021, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo®) in combination with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.
The Case of the Sensitive Staging System
Marianne, an oncology nurse navigator, is preparing a cancer treatment summary and survivorship care plan for Sylvia, who finished breast cancer treatment six weeks ago. Sylvia was treated with neoadjuvant therapy followed by mastectomy, reconstruction, and radiation. Her tumor was characterized as multifocal invasive ductal carcinoma, grade 2, estrogen and progesterone positive, and HER2/neu negative. Sylvia has no family history of breast cancer. Marianne notices that the oncologist recorded Sylvia’s cancer as a stage IB. Marianne wonders if the stage was determined before or after chemotherapy and surgery.
FDA Approves Cemiplimab-Rwlc for Locally Advanced and Metastatic Basal Cell Carcinoma
On February 9, 2021, the U.S. Food and Drug Administration (FDA) approved cemiplimab-rwlc (Libtayo®) for use in patients with locally advanced basal cell carcinoma previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate. FDA also granted accelerated approval to cemiplimab-rwlc for patients with metastatic BCC previously treated with an HHI or for whom an HHI is not appropriate.
FDA Approves Lisocabtagene Maraleucel for Relapsed or Refractory Large B-Cell Lymphoma
On February 5, 2021, the U.S. Food and Drug Administration (FDA) approved lisocabtagene maraleucel (Breyanzi®) 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 not otherwise specified—including DLBCL arising from indolent lymphoma—high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.
FDA Grants Accelerated Approval to Umbralisib for Marginal Zone and Follicular Lymphoma
On February 5, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to umbralisib (Ukoniq™), a kinase inhibitor including PI3K-delta and casein kinase CK1-epsilon, for adult patients with relapsed or refractory marginal zone lymphoma who have received at least one prior anti-CD20-based regimen and adult patients with relapsed or refractory follicular lymphoma who have received at least three prior lines of systemic therapy.
FDA Grants Accelerated Approval to Tepotinib for Metastatic NSCLC
On February 3, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tepotinib (Tepmetko®) for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition exon 14 skipping alterations.
Oncology Drug Reference Sheet: Tafasitamab-Cxix
Tafasitamab-cxix (Monjuvi®) received accelerated approval from the U.S. Food and Drug Administration in July 2020 in combination with lenalidomide for adults with relapsed or refractory diffuse large B-cell lymphoma.
FDA Approves Nivolumab Plus Cabozantinib for Advanced Renal Cell Carcinoma
On January 22, 2021, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo®) in combination with cabozantinib (Cabometyx®) as first-line treatment for patients with advanced renal cell carcinoma.
FDA Approves Fam-Trastuzumab Deruxtecan-Dxki for HER2-Positive Gastric Adenocarcinomas
On January 15, 2021, the U.S. Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki (Enhertu®) for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.
FDA Approves Crizotinib for Children and Young Adults With Relapsed or Refractory, Systemic ALK-Positive Anaplastic Large Cell Lymphoma
On January 14, 2021, the U.S. Food and Drug Administration (FDA) approved crizotinib (Xalkori®) for pediatric patients aged one year or older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK) positive. The safety and efficacy of crizotinib have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL.
Genomics Provides Insight on Exceptionally Responding Patients
Patients with cancer who experience unexpected and long-lasting treatment outcomes are considered exceptional responders, but researchers and clinicians had no insight as to why the patients did so well with treatment. Results of a new study now show that genomic characterizations of cancer can uncover genetic alterations that may contribute to the phenomenon, researchers reported in Cancer Cell.
Adding Nivolumab to Chemo Improves Survival for Advanced Gastric Cancer
First-line therapy combining nivolumab with chemotherapy improved median overall survival rates in patients with PD-L1-expressing gastric cancer by 3.3 months in a large international, multicenter trial. The findings were reported during the 2020 European Society for Medical Oncology virtual meeting.
Oncology Drug Reference Sheet: Alpelisib
When used in combination with fulvestrant, alpelisib (Piqray®) produced complete or partial responses in 29% of patients with PIK3CA-altered, estrogen receptor-positive advanced breast cancer in clinical trials. The U.S. Food and Drug Administration approved it for use in 2019.
Genomics May Trick PARP Inhibitors to Treat More Cancers
Turning on the body’s inflammasome with epigenetic therapy may improve the efficacy of PARP inhibitors across multiple tumor types, possibly expanding the therapy’s application to new cancers, researchers reported in Proceedings of the National Academy of Sciences.
FDA Approves Selinexor for Relapsed or Refectory Multiple Myeloma
On December 18, 2020, the U.S. Food and Drug Administration (FDA) approved selinexor (Xpovio®) in combination with bortezomib and dexamethasone for the treatment of adult patients with relapsed or refectory multiple myeloma who have received at least one prior therapy.
FDA Approves Relugolix for Advanced Prostate Cancer
On December 18, 2020, the U.S. Food and Drug Administration (FDA) approved the first oral gonadotropin-releasing hormone receptor antagonist, relugolix, (Orgovyx™) for adult patients with advanced prostate cancer.
FDA Approves Margetuximab-cmkb for Metastatic HER2-Positive Breast Cancer
On December 16, 2020, the U.S. Food and Drug Administration (FDA) approved margetuximab-cmkb (Margenza™) in combination with chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who previously received two or more anti-HER2 regimens, at least one of which was for metastatic disease.
Pancreatic Cancer Risk Factors, Diagnosis, Treatment, Side Effects, and Survivorship Considerations
Pancreatic cancer is the ninth most common cancer in the United States, accounting for 3% of all cancers but causing 7% of cancer-related deaths, which equates to about 57,500 diagnoses and 47,050 deaths each year. The average person’s risk for pancreatic cancer is about 1 in 64.
FDA Approves Pralsetinib for RET-Altered Thyroid Cancers
On December 1, 2020, the U.S. Food and Drug Administration (FDA) approved pralsetinib for patients aged 12 years and older with advanced or metastatic RET-mutant medullary thyroid cancer who require systemic therapy or RET fusion-positive therapy and who are refractory to radioactive iodine (if radioactive iodine is appropriate).
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.
FDA Grants Accelerated Approval to Naxitamab for High-Risk Neuroblastoma in Bone or Bone Marrow
On November 25, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to naxitamab (Danyelza®) in combination with granulocyte-macrophage colony-stimulating factor for pediatric patients one year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who demonstrate a partial response, minor response, or stable disease to prior therapy.
The Evolving Landscape of Cell Transplant Therapy in Cancer Care
Each year more than 50,000 stem cell transplantations are completed worldwide. The stimulation, harvesting, and therapeutic use of patient and donor cells has evolved as a treatment for diverse cancer diagnoses, and specially trained nurses are at the heart of the clinical trials and care delivery to propel cell transplant therapy across practice settings.
It’s Time to Take a New Look at Radiation Therapy
Radiation therapy (RT) has been used as a safe and effective treatment option for patients with cancer for more than a century. Like any cancer therapy, it does carry risks and side effects, but RT has improved drastically over the past 20 years and has even been shown to enhance the effectiveness of immunotherapy.
New Treatments in Radiation Oncology
Included in the treatment plan for approximately 50% of all patients with cancer, radiotherapy (RT) is a significant component of cancer care. RT is a technology-driven oncology modality, which means it has continually evolved since being introduced in cancer care in the early 20th century.
FDA Approves Nivolumab and Ipilimumab for Malignant Pleural Mesothelioma
On October 2, 2020, the U.S. Food and Drug Administration (FDA) approved nivolumab in combination with ipilimumab for the first-line treatment of adults with malignant pleural mesothelioma that cannot be removed by surgery. This is the first drug regimen approved for mesothelioma in 16 years and the second FDA-approved systemic therapy for mesothelioma.
Non-Hodgkin Lymphoma Symptoms, Diagnosis, Treatment, and Survivorship Recommendations
Lymphomas are hematologic malignancies, specifically of the lymphatic system. They are classified into two types: Hodgkin and non-Hodgkin (NHL). NHL is the seventh most common cancer in the United States and Hodgkin seen much less frequently as the 26th, but new treatment options have improved survival rates.
Blocking Fatty Acid Storage May Induce Glioblastoma Apoptosis
Turning off an enzyme that glioblastoma cells use to store the fatty acids they feed on as energy for rapid cell division may offer a new treatment option for the deadly cancer, researchers reported in Cell Metabolism.
FDA Rejects Atezolizumab in Combination With Paclitaxel as Treatment for Breast Cancer
On September 8, 2020, the U.S. Food and Drug Administration (FDA) announced it did not approve atezolizumab (Tecentriq®) in combination with paclitaxel for treatment of breast cancer after a clinical trial studying the use of atezolizumab and paclitaxel in patients with previously untreated inoperable locally advanced or metastatic triple negative breast cancer (mTNBC) showed the drug combination did not work to treat the disease.
Oncology Drug Reference Sheet: Rucaparib
Rucaparib (Rubraca®) has U.S. Food and Drug Administration approval for both maintenance and treatment indications in gynecologic cancers. It originally received accelerated approval in 2016 for the treatment of deleterious, BRCA variant–associated advanced ovarian cancer that has failed two or more chemotherapies. In 2018, it was approved for maintenance therapy of various gynecologic malignancies. Most recently, rucaparib received approval for BRCA-positive metastatic castration-resistant prostate cancer treatment after androgen-directed and chemotherapy.
Oncology Drug Reference Sheet: Enfortumab Vedotin-Ejfv
Enfortumab vedotin-ejfv (Padcev™) was granted accelerated approval in December 2019 for adults with locally advanced or metastatic urothelial cancer who previously received an immune checkpoint inhibitor (PD-1 or PD-L1 inhibitor) and platinum-containing therapy.
Myeloproliferative Neoplasm Symptoms, Diagnosis, Treatment, and Survivorship Recommendations
Myeloproliferative neoplasms are a group of blood cancers that start with a small mutation in the stem cells of the bone marrow. Although MPNs are quite rare, essential thrombocythemia, polycythemia vera, and myelofibrosis are the most common types. Each represents a mutation of a different source of stem cell.
Help Patients Understand Genomic Variants of Unknown Significance
Patients approach genetic testing, either for germline (inherited) or somatic (tumor) alterations, hoping it will provide valuable information about their cancer risk, prognosis, or treatment options. Next-generation sequencing makes it possible to test for panels of 40 or more genes simultaneously. By testing more genes, the possibility of finding an actionable, informative result improves, but so does the chance of having a result with one or more variants of unknown clinical significance.