The U.S. Food and Drug Administration (FDA) has designated 4D Path’s software a breakthrough device as a possible way to achieve a faster and more accurate breast cancer diagnosis based on tissue taken in a breast biopsy or resection. Named 4D Q-plasia OncoReader Breast, the software is intended to aid doctors in evaluating biopsies and resections (tumors that are surgically…
Conditions
Conditions
Opdivo Approved in Europe as Second-line Therapy for Advanced Esophageal Cancer
The European Commission has approved Opdivo (nivolumab) as a second-line treatment for adults with advanced inoperable, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC), who previously were treated with fluoropyrimidine and platinum chemotherapy agents. This decision follows a positive recommendation by the Committee for Medicinal Products for Human Use (CHMP), a branch of the European Medicines Agency. With…
FDA Approves FoundationOne Liquid CDx as Companion Test for Lynparza in mCRPC Patients
The U.S. Food and Drug Administration (FDA) has approved FoundationOne Liquid CDx to be used as a companion diagnostic test to identify men with metastatic castration-resistant prostate cancer (mCRPC) who are likely to benefit from treatment with Lynparza (olaparib). Developed by Foundation Medicine, the test is a blood-based biopsy assessment approved by the FDA to…
Assisted Reproductive Technology Does Not Raise Risk of Ovarian Cancer, Study Indicates
Women who use assisted reproductive technology to help them conceive a child appear not to be at an increased risk of developing ovarian cancer, a nationwide study conducted in the Netherlands has found. The study, “Long-Term Risk of Ovarian Cancer and Borderline Tumors After Assisted Reproductive Technology,” was published in the Journal of the National…
Social Inequalities Found in US Counties With Highest Alzheimer’s Rates Among Blacks, Latinos
A recent report found deep social inequalities in U.S. counties with the highest Alzheimer’s rates among Blacks and Latinos. Inequalities related to education, income, food insecurity, and the physical environment are collectively known as social determinants of health and are inextricably tied to location, according to the report from UsAgainstAlzheimer’s Center for Brain Health Equity…
Anixa Biosciences, Cleveland Clinic Developing Breast Cancer Vaccine
Anixa Biosciences and the Cleveland Clinic have filed an investigational new drug application for a breast cancer vaccine with the U.S. Food and Drug Administration. The vaccine technology was developed by researchers at the Cleveland Clinic. Funding from the U.S. Department of Defense is expected to enable completion of two Phase 1 clinical trials, according…
CRISPR-Cas9 in Lipid Nanoparticles Found to Safely Treat Ovarian Cancer in Mice
For the first time, researchers safely and effectively treated cells and mice with ovarian cancer using the CRISPR-Cas9 gene-editing tool plus a newly developed lipid nanoparticle (LNP) delivery system, which targeted and destroyed the cancer cells by genetic manipulation. This new therapeutic strategy has the potential to treat not only other types of cancer, but…
FDA Lifts Hold on Phase 1 Trial for Car-T-Cell Therapy UCARTCS1A
The U.S. Food and Drug Administration (FDA) has lifted the clinical hold placed on a Phase 1 trial assessing Cellectis’ investigational CAR T-cell therapy, UCARTCS1A, for the treatment of relapsed or refractory multiple myeloma. In September, the FDA placed a hold on the MELANI-01 trial (NCT04142619) based on safety concerns, after a patient who received…
FDA Approves First PSMA-targeted PET Imaging Agent for Prostate Cancer
The U.S. Food and Drug Administration (FDA) has approved Gallium 68 PSMA-11 (Ga 68 PSMA-11) as a positron emission tomography or PET imaging agent for men with prostate cancer. The molecule is the first approved PET imaging agent that detects prostate cancer lesions by targeting the prostate-specific membrane antigen (PSMA) — a protein produced at…
Keytruda-Lenvima Combo in Kidney Cancer Better Than Sutent in Improving Survival
A combination of Keytruda (pembrolizumab) and Lenvima (lenvatinib) worked better than standard Sutent (sunitinib) in improving survival outcomes among adults with untreated advanced renal cell carcinoma (RCC) — the most common type of kidney cancer in adults — according to top-line data from a Phase 3 clinical trial. A different Lenvima combination, with Novartis’ Afinitor (everolimus),…
FDA Approves Less Frequent Treatment Regimen for Imfinzi in NSCLC, Bladder Cancer
The U.S. Food and Drug Administration (FDA) has approved a new dosing regimen for Imfinzi (durvalumab) for the treatment of certain non-small cell lung cancer (NSCLC) and bladder cancer patients. Granted under priority review, the approval allows Imfinzi to be administered at a fixed dose of 1,500 mg every four weeks for patients weighing more than 30 kg (about…
Dana-Farber, Quest Diagnostics Studying COVID-19 Prevalence in Myeloma
The Dana-Farber Cancer Institute and Quest Diagnostics, the laboratory testing company, are conducting a study to measure the prevalence of COVID-19 among individuals with or at risk of developing multiple myeloma. The aim of the Immune Profiling with Antibody-based COVID-19 Testing study, or IMPACT, is to understand what happens to the immune system during a…