Two months after announcing an inquiry into reports of new cancers in patients treated with CAR T-cell therapies, the FDA is directing makers of these therapies to add new safety warnings to product labels describing this risk. Companies have 30 calendar days to comply. By FRANK VINLUAN Post a comment / at 7:04 PM Stricter safety warnings are coming for the cancer treatments known as CAR T-therapies. The FDA is instructing makers of the six approved cell therapies in the class to revise their labels to state that these treatments for cancer come with the risk of causing new cancers. The labels of CAR T-therapies already come with black box warnings that alert physicians and patients of risks that include an excessive immune response and neurotoxicity. Letters sent to the drugmakers last Friday instruct them to add additional language to the boxed warning stating that T cell malignancies have occurred following the treatment of ...
Systemic Lupus Erythematosus (SLE), widely known as lupus, is an autoimmune condition where the body’s immune system mistakenly attacks its own tissues and organs. This disease can lead to inflammation affecting various body parts, including joints, skin, kidneys, blood cells, brain, and heart. Among its manifestations, lupus nephritis stands out as one of the most severe and common, often resulting in significant morbidity and mortality. Early detection of kidney involvement in lupus patients and prompt intervention are critical in mitigating the associated pain, suffering, and potential fatality. Now, researchers have discovered new biomarkers with improved diagnostic performance for the early detection of lupus nephritis. In a significant advancement, a research team from the University of Houston (Houston, TX, USA) employed Proximity Extension Assay (PEA) proteomics—a method focused on the study of proteins in terms of their interactions, functions, compositions, and structures—on urine samples from lupus patients. This approach led to ...
White blood cells (WBC), or leukocytes, are key indicators of an individual’s immune system health. High or low WBC counts can signify the severity of an infection, indicate life-threatening conditions like sepsis, or assist in monitoring patient responses to therapies like chemotherapy and psychotropic drugs. Generally, the blood collected for WBC testing is sent to a central lab for analysis that sends results within hours, making it inconvenient and delaying time-sensitive diagnosis or treatment. Now, an innovative device can rapidly count a person’s WBC with a single drop of blood, similar to the way glucometers rapidly scan for blood sugar levels, enabling rapid testing and improved triaging for infections. Called the CytoTracker Leukometer, the device developed by researchers at Rutgers startup RizLab Health Inc. (Princeton, NJ, USA) can quickly aid the detection of elevated or reduced WBC counts. The device has undergone comprehensive testing, comparing its performance with conventional ...
Tumors continuously release DNA from dying cells into the bloodstream, which is rapidly broken down. This makes it difficult for existing blood tests to detect the minute amounts of tumor DNA present at any given time. Now, a team of researchers has developed an innovative method to amplify the detection of tumor DNA in blood, a breakthrough that could enhance cancer diagnosis and treatment monitoring. Researchers at Massachusetts Institute of Technology (MIT, Cambridge, MA, USA) have created “priming agents,” injectable molecules that temporarily slow the clearance of circulating tumor DNA from the bloodstream. These priming agents target the body’s two main mechanisms for removing circulating DNA: DNases, enzymes that break down DNA in the blood, and macrophages, immune cells that absorb cell-free DNA during blood filtration through the liver. The researchers developed two types of priming agents. The first is a monoclonal antibody that attaches to circulating DNA, shielding ...
More than five years after an FDA accelerated approval in a subtype of progressive colorectal cancer, Bristol Myers Squibb now has data supporting its checkpoint inhibitor doublet in newly diagnosed patients. But another approval may have to wait. The dual immunotherapy combo of Opdivo and Yervoy cut the risk of disease progression or death by 79% compared with chemotherapy—with or without targeted therapies—in patients newly diagnosed with metastatic colorectal cancer that was microsatellite instability-high or mismatch repair-deficient (MSI-H/dMMR). Investigators shared the results, from the CheckMate 8HW study, at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium. After about two years of median follow-up, 72% of patients who received the anti-PD-1/CTLA-4 combo were alive without disease progression, versus 14% in the control group. The results “have potentially practice-changing implications” for previously untreated MSI-H/dMMR metastatic colorectal cancer, lead study author Thierry Andre, M.D., from the Sorbonne Université in Paris, said in a ...
Opdivo plus Yervoy shows promise in treating patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer. Image Credit: Adobe Stock Images/Crystal light The combination of Bristol Myers Squibb’s Opdivo (nivolumab) with Yervoy (ipilimumab) showed significant improvements in progression-free survival (PFS) as a first-line treatment for patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC)in the Phase III CheckMate -8HW trial. The combination produced a 79% reduction in the risk of disease progression or death compared to chemotherapy, according to the trial. “Patients with MSI-H/dMMR metastatic colorectal cancer are less likely to benefit from chemotherapy,” said Thierry Andre, MD, head of the medical oncology department, Sorbonne University, Hospital Saint-Antoine, Paris, France, in a press release. “An impressive improvement in PFS and sustained benefit beginning at three months was observed with nivolumab plus ipilimumab versus chemotherapy in this trial. These results demonstrate ...
The American Society of Clinical Oncology Gastrointestinal Oncology Symposium (ASCO GI) was held in San Francisco from January 18 to 20, local time. As an academic event in the field of gastrointestinal tumors, ASCO GI showcased several heavyweight and innovative scientific advances in the field, especially the release of the Late-breaking Abstract (LBA) study, which will lead the way to a new direction in clinical treatment. Phase III study (ESCORT-NEO/NCCES01), led by Prof. Li Yin of Cancer Hospital, Chinese Academy of Medical Sciences, with the participation of 24 centers across China, was selected as LBA. Professor Li Yin reported the results of the study, which is the world’s first perioperative immunization Phase III study in esophageal cancer. Neoadjuvant carelizumab in combination with chemotherapy showed a significantly better pCR rate than that of neoadjuvant chemotherapy, achieving the primary endpoint without increasing the risk of surgery and with a manageable safety profile. ...
Shanghai Shengdi Pharmaceuticals Co., Ltd., a subsidiary of Jiangsu Hengrui Pharmaceuticals Company Limited (hereinafter referred to as the “Company”), has received the Notice of Approval for Clinical Trial of Adebenosumab Injection approved by the State Drug Administration (hereinafter referred to as the “State Drug Administration”). Ltd. has received the “Notice of Approval for Clinical Trial” from the State Drug Administration (hereinafter referred to as “SDA”) for Adebenosumab Injection, which will be launched in the near future. The relevant information is announced as follows: I. Basic information of the drug Drug Name: Adebelizumab Injection Formulation: Injection Application: Clinical Trial Acceptance No.: CXSL2300746 Conclusion of Approval: According to the Drug Administration Law of the People’s Republic of China and relevant regulations, after examination, the application for clinical trial of Adebelizumab Injection accepted on October 31, 2023 complies with the relevant requirements for drug registration, and approval is granted for the product to ...
On January 16th, Zhengda Tianqing received the Certificate of Drug Registration approved by the State Drug Administration (NMPA), approving the registration and marketing of Eltrombopag olamine tablets (trade name: Tepsin) for the following indications: for use in patients with chronic immune thrombocytopenia (ITP) who have had a poor response to previous treatments of glucocorticosteroids and immunoglobulins, as well as in children aged 6 years and above. ) patients to raise platelet counts and reduce or prevent bleeding. This product is intended for use only in patients with ITP who are at increased risk of bleeding due to thrombocytopenia and clinical conditions. Eltrombopag olamine tablets are an oral, small-molecule, nonpeptide thrombopoietin receptor agonist (TPO-RA) that works by increasing platelet counts. In the Chinese Guidelines for the Diagnosis and Treatment of Primary Immune Thrombocytopenia in Adults (2020 Edition), Eltrombopag is the only drug with the highest level (1a) of evidence and A ...
Variations in blood cell concentration can be indicative of several health conditions, including infections, inflammatory diseases, malignant blood disorders, and AIDS (Acquired Immune Deficiency Syndrome). Detecting these variations is crucial for diagnosing, treating, and managing these diseases. Traditional methods for measuring blood cell concentration, like using a hemocytometer, typically require an optical microscope. Alternatively, flow cytometers offer a more efficient method for sorting and counting blood cells in fluids, but they are often large and complex, weighing between 9-30 kg, thus limiting their use to laboratory and hospital settings. This restricts the availability of point-of-care testing (POCT) and can delay treatment for patients. Now, a proposed portable smart blood cell analyzer could help overcome the limitations of conventional methods for blood cell concentration detection. Developed by the Harbin Institute of Technology (HIT, Heilongjiang, China), this innovative analyzer integrates a miniature fluorescence microscope, typically used in neuroscience and behavioral research, with ...
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