FDA Approves Bosutinib for Pediatric Patients With Chronic Myelogenous Leukemia
On September 26, 2023, the U.S. Food and Drug Administration (FDA) approved bosutinib (Bosulif®) for pediatric patients aged 1 year and older with chronic phase Ph+ chronic myelogenous leukemia that is newly diagnosed or resistant or intolerant to prior therapy. FDA also approved a new 50 mg and 100 mg capsule dosage form.
United States and European Union Form Joint Task Force to Tackle Global Health Issues
Joining two powerful entities may be what it takes to overcome cancer and global health threats and improve health architecture around the world. In May 2023, U.S. Secretary of Health and Human Services Xavier Becerra and the European Union Commissioner for Health and Food Safety Stella Kyriakides announced that the countries had formed the EU–U.S. Health Task Force, a new joint effort to address global health.
U.S. Senators Tina Smith and Jerry Moran Reintroduce Oral Parity for Cancer Drugs Bill
Equal reimbursement for oral versus IV anticancer agents—also known as oral parity—has been a legislative priority for ONS since the first bill was introduced in the U.S. Congress eight years ago. Working through ONS’s broad coalitions, ONS members have championed patient access to oral anticancer therapies to the seven remaining states without a similar law on the books. Building on that work, on June 15, 2023, U.S. Senators Tina Smith (D-MN) and Jerry Moran (R-KS) reintroduced the bipartisan Cancer Drug Parity Act to further support that goal.
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.
Uterine Cancers Added to World Trade Center Health Program List
Almost 22 years after the September 11, 2001, atacks, the World Trade Center Health Program has added all types of uterine cancer to its list of WTC-related health conditions. The WTC Health Program assists patients with treatment costs for uterine cancers that meet WTC-related health condition eligibility and certification requirements.
Hispanic Patients Are at Higher Risk for Aggressive Prostate Cancer but Less Likely to Get Treatment
Compared to their non-Hispanic White counterparts, most Hispanic patients with localized prostate cancer are nearly 20% more likely to have aggressive disease, but the risk varies based on their country of origin, researchers reported in study findings published in Prostate Cancer and Prostatic Diseases. Additionally, they found that the population faces disparities in access to care, with only approximately 60% receiving appropriate treatment.
During or After Chemo, Exercise Fights Fatigue and Supports Cancer Recovery
Patients who engage in physical activity during or after cancer treatment are less fatigued and return to their usual daily activities faster than those who don’t exercise, researchers reported in JACC: CardioOncology. The benefit is highest among patients who are active during treatment but still pronounced for those who resume physical activity after completing treatment.
Build Your Confidence in Next-Generation Sequencing With Nursing Toolkits and Resources
Essential biomarker testing technologies like next-generation sequencing are increasing our comprehension of cancer genetics and genomics. Biomarker testing results provide prognostic and predictive information about a tumor’s biology and growth to guide treatment decisions. Patients with cancer are turning to their oncology nurses to help them understand their complex test results and corresponding recommended treatment plans, yet many oncology nurses have minimal, if any, formal training in the area.
Chemo Combo May Be a Bladder Cancer Treatment Alternative During BCG Shortage
Overall survival among patients with non–muscle-invasive bladder cancer who are treated with adjuvant gemcitabine and docetaxel is comparable to overall survival for treatment with bacillus Calmette-Guérin (BCG), researchers reported in the Journal of Urology. The evidence could support a treatment alternative for high-risk patients during the BCG shortage.
FDA Approves Updated Drug Labeling Including New Indications and Dosing Regimens for Capecitabine Tablets Under Project Renewal
On December 14, 2022, the U.S. Food and Drug Administration approved updated labeling for capecitabine tablets (Xeloda®) under Project Renewal, an Oncology Center of Excellence (OCE) initiative aimed at updating labeling information for certain older oncology drugs to ensure information is clinically meaningful and scientifically up to date. Capecitabine is the first drug to receive a labeling update under the pilot program.
Overcome Inequalities in Cancer Treatment Options Across the Ages
Larry is an 83-year-old rancher who was diagnosed with pancreatic adenocarcinoma and treated with gemcitabine and nab-paclitaxel. A three-month follow-up scan reveals recurrent disease. Larry’s son tells you he wants to explore clinical trials but is frustrated that several promising trials do not accept patients older than 70 years. He asks you why a person’s chronologic age is a major exclusion factor and their performance status is only considered after they meet the age criteria. He also asks you whether his father’s age influenced the choice between first-line therapy with FOLFIRINOX or gemcitabine and nab-paclitaxel.
Policy Investments in Biomarkers Are Changing Cancer Outcomes
Since the late 1990s, U.S. Congress has made a concerted effort to increase federal funding for the National Institutes of Health’s (NIH’s) biomedical research and clinical trials. Through rare but always bipartisan largess, legislative appropriators have seen the benefits of investing in the science for precision medicine; supporting genetic-grounded, patient-centered care; and changing the quality and longevity of life for millions of people, including those with cancer diagnoses.
Micro-Organospheres Create Molecular Model of Patients’ Cancer in Just Two Weeks
Biomarker- and molecular-driven technologies such as molecular models can precisely predict how an individual’s cancer will respond to certain treatments, the pinnacle of precision oncology. However, established modeling systems such as patient-derived xenografts and patient-derived organoids require large tissue samples and take months or even a year to obtain results, barriers that have limited their application in regular practice.
Predictive and Diagnostic Biomarkers
Biomarkers, also called molecular markers or signature molecules, can help clinicians characterize alterations in tumors through the detection of specific DNA, RNA, protein, or metabolomic profiles. These pieces of the cancer puzzle are part of precision oncology that the cancer care team can use to assess patients’ cancer risk and prognosis or monitor disease progression. Biomarkers are also a key factor in determining and tailoring treatment methods and their likelihood of success.
The Life of Marie Curie and Her Contributions to Oncology
November 7, 2022, is the 155th birthday of Maria Sklodowska, who is better known as Madame Marie Curie, one of the greatest minds of chemistry, physics, and radiation oncology. The day also marks the fifth anniversary of #WomenWhoCurie, a social media campaign from the Society for Women in Radiation Oncology that supports and increases visibility of women in radiation oncology.
Biden Cancer Moonshot Relaunch Will “End Cancer as We Know It”
In a clarion call for action seven years ago, President Barack Obama unveiled the Cancer Moonshot during his last State of the Union address. In that speech, Obama recalled, “Last year, Vice President Joe Biden said that with a new moonshot, America can cure cancer. Tonight, I’m announcing a new national effort to get it done. And I’m putting Joe in charge of Mission Control.”
CAR T-Cell Therapy Programs
Debuting in human clinical trials just a decade ago, chimeric antigen receptor (CAR) T-cell therapy was quickly hailed as a breakthrough cancer treatment for certain hematologic cancers. Today, patients and providers have access to 22 U.S. Food and Drug Administration (FDA)–approved cellular and gene therapy products, and CAR T-cell therapy is available beyond large academic research centers.
Fiber—but Not Probiotics—Boosts Immunotherapy Response for Melanoma
Patients with melanoma who consume a high-fiber diet during treatment with immune checkpoint inhibitors (ICIs) or anti-PD-1 therapy experience longer progression-free survival than those who don’t, researchers reported in Science. And probiotic supplementation, often considered a healthy behavior, reduces immunotherapy response.
Nursing Considerations for ICI-Related Myocarditis
Before immunotherapies like immune checkpoint inhibitors (ICIs) became a cancer treatment option, myocarditis typically developed in the presence of infections, drug allergies, or autoimmune diseases. Activating the immune system with ICIs can also trigger autoimmune-like adverse events such as myocarditis, and although its incidence in patients with cancer is low, mortality is high.
ONS Launches New Learning Extension Activities for Popular Cancer Basics Course
The Oncology Nursing Society’s (ONS’s) new Learning Extension Activities Plan (LEAP), an opportunity for student nurse learners to further develop their knowledge of some of the topics covered in ONS’s Cancer Basics course, was created to help faculty members teach oncology to nursing students.
How Liquid Biopsies Are Used in Cancer Treatment Selection
Biomarker testing is an essential tool when choosing the right treatment for many advanced solid cancers. However, tissue-based testing may take weeks to get results with a chance that not enough tissue was collected to complete the entire biomarker panel. Blood draw–based liquid biopsies may be a useful alternative to identify a tumor’s biomarker details and can be performed by testing for circulating tumor DNA (ctDNA).
Today’s Immunotherapy Combinations
Immunotherapy has revolutionized cancer treatment, especially for patients with diseases considered otherwise incurable. Since May 2017, the U.S. Food and Drug Administration (FDA) has approved 27 immunotherapy combinations, including chemoimmunotherapy and regimens with targeted therapies, and researchers are reporting highly promising data from clinical trials of its combination with radiation.
FDA Approves Rituximab Plus Chemotherapy for Pediatric Cancer Indications
On December 2, 2021, the U.S. Food and Drug Administration (FDA) approved rituximab (Rituxan®) in combination with chemotherapy for pediatric patients aged at least 6 months to 18 years with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma, Burkitt lymphoma, Burkitt-like lymphoma, or mature B-cell acute leukemia.
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.