On December 15, 2023, the U.S. Food and Drug Administration (FDA) approved enfortumab vedotin-ejfv (Padcev^®) in combination with pembrolizumab (Keytruda^®) for patients with locally advanced or metastatic urothelial cancer (la/mUC). FDA previously granted the combination accelerated approval for patients with la/mUC who are ineligible for cisplatin-containing chemotherapy.

On December 14, 2023, the U.S. Food and Drug Administration (FDA) approved belzutifan (Welireg™) for patients with advanced renal cell carcinoma following treatment with a programmed death receptor-1 or programmed death-ligand 1 inhibitor and a vascular endothelial growth factor–tyrosine kinase inhibitor (VEGF-TKI).

On December 13, 2023, the U.S. Food and Drug Administration (FDA) approved eflornithine (Iwilfin™) to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who demonstrated at least a partial response to prior multiagent, multimodality therapy, including anti-GD2 immunotherapy. This represents the first FDA approval of a therapy intended to reduce the risk of relapse in pediatric patients with HRNB.

On December 1, 2023, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pirtobrutinib (Jaypirca™) for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.

On November 27, 2023, the U.S. Food and Drug Administration (FDA) approved nirogacestat (Ogsiveo™) for use in adult patients with progressing desmoid tumors who require systemic treatment. Nirogacestat is the first approved treatment for desmoid tumors.

On November 17, 2023, the U.S. Food and Drug Administration (FDA) announced that B. Braun Medical, Inc., is recalling its Infusomat Space Volumetric Infusion Pump System because of faulty occlusion alarms, causing the pump to stop delivering medications, including high-risk medications such as vasopressors. Interrupting the infusion of high-risk medications may lead to hemodynamic instability, which may be life-threatening or lead to death in some cases. FDA is aware of 51 reports, one injury, and one death related to the recall. The agency has identified it as a class I recall, the most serious type of recall, where use of the devices may cause serious injuries or death.

On November 16, 2023, the U.S. Food and Drug Administration (FDA) approved enzalutamide (Xtandi^®) for non-metastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis.

On November 16, 2023, the U.S Food and Drug Administration (FDA) approved pembrolizumab (Keytruda^®) with fluoropyrimidine- and platinum-containing chemotherapy for first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.

On November 16, 2023, the U.S. Food and Drug Administration (FDA) approved capivasertib (Truqap™) with fulvestrant for adult patients with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1, or PTEN alterations, as detected by an FDA-approved test, following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. FDA also approved the FoundationOne^®CDx assay as a companion diagnostic device to identify patients with breast cancer for treatment with capivasertib with fulvestrant.

On November 15, 2023, the U.S. Food and Drug Administration (FDA) approved repotrectinib (Augtyro™) for locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). This is the first FDA approval for treatment of patients with ROS1-positive NSCLC who have previously received a ROS1 tyrosine kinase inhibitor (TKI), in addition to patients who are TKI naïve.

On November 7, 2023, the U.S. Food and Drug Administration (FDA) revised the existing indication of pembrolizumab (Keytruda^®) with trastuzumab, fluoropyrimidine, and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma. This updated indication, which remains approved under accelerated approval regulations, restricts its use to patients whose tumors express PD-L1 (CPS ≥ 1), as determined by an FDA-approved test.

On November 8, 2023, the U.S. Food and Drug Administration (FDA) approved fruquintinib (Fruzaqla™) for adult patients with metastatic colorectal cancer who received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy.

On October 31, 2023, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda^®) used with gemcitabine and cisplatin for the treatment of locally advanced unresectable or metastatic biliary tract cancer.

On October 27, 2023, the U.S. Food and Drug Administration (FDA) approved toripalimab-tpzi (Loqtorz) with cisplatin and gemcitabine for first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma (NPC). FDA also approved toripalimab-tpzi as a single agent for adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy.

On October 24, 2023, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo^®) for the treatment of adult patients with relapsed or refractory myelodysplastic syndrome (MDS) with a susceptible isocitrate dehydrogenase-1 (IDH1) variant, as detected by an FDA-approved test. The agency also approved the Abbott RealTime IDH1 assay as a companion diagnostic device to select patients for ivosidenib treatment.

On October 20, 2023, the U.S Food and Drug Administration (FDA) granted accelerated approval to entrectinib (Rozlytrek^®) for pediatric patients older than 1 month with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance variant, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory standard therapy. In August 2019, FDA granted entrectinib accelerated approval for pediatric patients aged 12 years or older for the indication.

On October 16, 2023, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda^®) with platinum-containing chemotherapy as neoadjuvant treatment and with continuation of single-agent pembrolizumab as postsurgical adjuvant treatment for resectable (tumors ≥ 4 cm or node positive) non-small cell lung cancer (NSCLC).

On October 13, 2023, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo^®) for the adjuvant treatment of completely resected stage IIB/C melanoma in patients aged 12 years and older.

On October 11, 2023, the U.S. Food and Drug Administration (FDA) approved encorafenib (Braftovi^®) with binimetinib (Mektovi^®) for adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E variant, as detected by an FDA-approved test.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Poorer outcomes among males receiving BRAF or MEK inhibitors for melanoma may be related to an increase in androgen receptors, researchers discovered in study findings published in Nature.

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.”

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.

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.

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.

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.

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).

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.

The extra or missing chromosomes—also called aneuploidy—in 90% of cancer cells may be a factor in treatment resistance, a new study shows. Researchers reported the findings in Developmental Cell.

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. 

All cells (healthy cells and tumor cells) in the body shed DNA, called cell-free DNA (cfDNA). When it’s only from tumor cells, it’s referred to as circulating tumor DNA (ctDNA), although cfDNA and ctDNA are sometimes used interchangeably.

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.

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.

Progression-free and overall survival rates for patients with metastatic testicular cancer have significantly grown since 1990, researchers reported in the Journal of Clinical Oncology.

A protein called AMBRA1 may be to blame for tumor resistance to CDK4/6 inhibitors, according to results from international teams of researchers that were reported in Nature.

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.