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Nogapendekin Alfa Inbakicept
Nogapendekin alfa inbakicept, sold under the brand name Anktiva, is a fixed-dose combination medication used for the treatment of bladder cancer. It is an interleukin-15 receptor agonist. It is given in combination with Bacillus Calmette-Guérin via intravesical drug delivery. It contains nogapendekin alfa, a human IL-15N72D variant; and inbakicept, an interleukin 15 receptor subunit alpha. The most common adverse reactions include increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills, and pyrexia. Nogapendekin alfa inbakicept was approved for medical use in the United States in April 2024. The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. Medical uses Nogapendekin alfa inbakicept is indicated with Bacillus Calmette-Guérin for adults with Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer with carcinoma in ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Interleukin-15 Receptor
Interleukin-15 receptor is a type I cytokine receptor, binding interleukin-15. Structure The IL-15 receptor is composed of the IL-2Rβ and γc subunits, along with a unique ligand-specific subunit, IL-15Rα, which bears homology to IL-2Rα. These receptor proteins feature protein-binding motifs known as "sushi domains." In both humans and mice, these receptors and their corresponding ligands are physically linked in the genome. Due to their shared receptor usage, IL-2 and IL-15 exhibit many similarities in their effects on lymphoid cells. Although the receptors for IL-2 and IL-15 share many structural analogies, two significant differences persist: Firstly, IL-15Rα has a broader expression compared to IL-2Rα, IL-2Rβ, and γc. It is found on lymphoid cells, dendritic cells (DCs), fibroblasts, epithelial cells, liver cells, intestinal cells and other cells and is thought to present IL-15 in trans to cells expressing IL-15β and γ chains. Secondly, IL-15Rα exhibits a ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Intravesical Drug Delivery
Intravesical drug delivery is the drug delivery, delivery of medications directly into the bladder by urinary catheter. This method of drug delivery is used to directly target diseases of the bladder such as interstitial cystitis and bladder cancer, but currently faces obstacles such as low drug retention time due to washing out with urine and issues with the low permeability of the bladder wall itself. Due to the advantages of directly targeting the bladder, as well as the effectiveness of penetration enhancers, permeability enhancers, advances in intravesical drug carriers, and mucoadhesion, mucoadhesive, intravesical drug delivery is becoming more effective and of increased interest in the medical community. Advantages Delivering drugs directly to the target bladder site allows for maximizing drug delivery while minimizing systemic effects. Delivering the treatment directly to the site allows for more effective dosages to be given since high concentrations of drug in the bl ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
ALT-803
Interleukin-15 (IL-15) is a protein that in humans is encoded by the IL15 gene. IL-15 is an inflammatory cytokine with structural similarity to Interleukin-2 (IL-2). Like IL-2, IL-15 binds to and signals through a complex composed of IL-2/IL-15 receptor beta chain (CD122) and the common gamma chain (gamma-C, CD132). IL-15 is secreted by mononuclear phagocytes (and some other cells) following infection by virus(es). This cytokine induces the proliferation of natural killer cells, i.e. cells of the innate immune system whose principal role is to kill virally infected cells. Expression IL-15 was discovered in 1994 by two different laboratories, and characterized as T cell growth factor. Together with Interleukin-2 (IL-2), Interleukin-4 ( IL-4), Interleukin-7 ( IL-7), Interleukin-9 ( IL-9), granulocyte colony-stimulating factor (G-CSF), and granulocyte-macrophage colony-stimulating factor ( GM-CSF), IL-15 belongs to the four α-helix bundle family of cytokines. IL-15 is consti ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Fixed-dose Combination Medication
A combination drug is a combination of two or more pharmaceutical drugs as active ingredients combined into a single dosage form, typically as a ''fixed-dose combination'', with each constituent standardized to specifications of a fixed dose. Fixed-dose combinations are mass-produced and mass marketed, intended to serve as a near universal treatment for a large patient population with diverse medical histories, conditions, predisposition thereof, and treatment requirements. A '' polypill'' is a pharmacy or capsule containing four or more active ingredients, often needing to be compounded at a specialized pharmacy in order to satisfy the specifications of a patient's personalized prescription and treatment plan, including dosage form, medicinal dosing, and/or mechanism of release. Polypills encompass approved prescription drugs and over the counter drugs, at times including nutritional supplements, amino acids, vitamins, minerals, and hormones. Fixed-dose combination drugs ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Bladder Cancer
Bladder cancer is the abnormal growth of cells in the bladder. These cells can grow to form a tumor, which eventually spreads, damaging the bladder and other organs. Most people with bladder cancer are diagnosed after noticing blood in their urine. Those suspected of having bladder cancer typically have their bladder inspected by a thin medical camera, a procedure called cystoscopy. Suspected tumors are removed and examined to determine if they are cancerous. Based on how far the tumor has spread, the cancer case is assigned a stage 0 to 4; a higher stage indicates a more widespread and dangerous disease. Those whose bladder tumors have not spread outside the bladder have the best prognoses. These tumors are typically surgically removed, and the person is treated with chemotherapy or one of several immune-stimulating therapies. Those whose tumors continue to grow, or whose tumors have penetrated the bladder muscle, often have their bladder surgically removed ( radical cy ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Intravesical Drug Delivery
Intravesical drug delivery is the drug delivery, delivery of medications directly into the bladder by urinary catheter. This method of drug delivery is used to directly target diseases of the bladder such as interstitial cystitis and bladder cancer, but currently faces obstacles such as low drug retention time due to washing out with urine and issues with the low permeability of the bladder wall itself. Due to the advantages of directly targeting the bladder, as well as the effectiveness of penetration enhancers, permeability enhancers, advances in intravesical drug carriers, and mucoadhesion, mucoadhesive, intravesical drug delivery is becoming more effective and of increased interest in the medical community. Advantages Delivering drugs directly to the target bladder site allows for maximizing drug delivery while minimizing systemic effects. Delivering the treatment directly to the site allows for more effective dosages to be given since high concentrations of drug in the bl ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Food And Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, Prescription drug, prescription and Over-the-counter drug, over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, Animal feed, animal foods & feed and Veterinary medicine, veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C). However, the agency also enforces other laws, notably Section 361 of the Public Health Service Act as well as associated regulations. Much of this regulatory-enforcement work is ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
First-in-class Medication
A first-in-class medication is a prototype drug that uses a "new and unique mechanism of action" to treat a particular medical condition. While the Food and Drug Administration's Center for Drug Evaluation and Research tracks first-in-class medications and reports on them annually, first-in-class is not considered a regulatory category. Although many first-in-class medications qualify as breakthrough therapies, Regenerative Medicine Advanced Therapies and/or orphan drugs, first-in-class status itself has no regulatory effect. Examples Controversy Safety By definition, a first-in-class drug does not have the safety evidence from analogous products that not-first-in-class drugs would have. However, a study investigating recalls and warnings in relation to first-in-class drugs approved between 1997 and 2012 by Health Canada has found that first-in-class drugs actually have a more favourable benefit-to-harm ratio. Economics First-in-class drugs are often seen as commerc ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Indicated
In medicine, an indication is a valid reason to use a certain test, medication, procedure, or surgery. There can be multiple indications to use a procedure or medication. An indication can commonly be confused with the term diagnosis. A diagnosis is the assessment that a particular medical condition is present while an indication is a reason for use. The opposite of an indication is a contraindication, a reason to withhold a certain medical treatment because the risks of treatment clearly outweigh the benefits. In the United States, indications for prescription drugs are approved by the FDA. Indications are included in the Indications and Usage section of the Prescribing Information. The primary role of this section of labeling is to enable health care practitioners to readily identify appropriate therapies for patients by clearly communicating the drug's approved indication(s). The Indications and Usage section states the disease or condition, or manifestation or symptoms thereof ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Bacillus Calmette-Guérin
The Bacillus Calmette–Guérin (BCG) vaccine is a vaccine primarily used against tuberculosis (TB). It is named after its inventors Albert Calmette and Camille Guérin. In countries where tuberculosis or leprosy is common, one dose is recommended in healthy babies as soon after birth as possible. In areas where tuberculosis is not common, only children at high risk are typically immunized, while suspected cases of tuberculosis are individually tested for and treated. Adults who do not have tuberculosis and have not been previously immunized, but are frequently exposed, may be immunized, as well. BCG also has some effectiveness against Buruli ulcer infection and other nontuberculous mycobacterial infections. Additionally, it is sometimes used as part of the treatment of bladder cancer. Rates of protection against tuberculosis infection vary widely and protection lasts up to 20 years. Among children, it prevents about 20% from getting infected and among those who do get inf ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
