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Enfortumab vedotin, sold under the brand name Padcev, is an antibody-drug conjugate [6] used for the treatment of urothelial cancer. [4] [7] It is a nectin-4-directed antibody and microtubule inhibitor conjugate. [4] [7] Enfortumab refers to the monoclonal antibody part, and vedotin refers to the payload drug (MMAE) and the linker. [5]
Monomethyl auristatin E is an antimitotic agent which inhibits cell division by blocking the polymerisation of tubulin.The linker to the monoclonal antibody is stable in extracellular fluid, but is cleaved by cathepsin once the conjugate has entered a tumor cell, thus activating the antimitotic mechanism.
The FDA accepts Seattle Genetics (SGEN) and Astellas' BLA for enfortumab vedotin under a priority review to treat advanced/metastatic urothelial cancer. A verdict is pending on Mar 15, 2020.
Treatment of people aged twelve years of age and older with solid tumors that: have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy [2]
The European Medicines Agency accepts Seagen (SGEN) and Astellas Pharma's marketing application for enfortumab vedotin for treating adult patients with advanced/metastatic urothelial cancer.
Tisotumab vedotin, sold under the brand name Tivdak, is an antibody-drug conjugate used to treat cervical cancer. [1] It is a combination of tisotumab, a monoclonal antibody against tissue factor , and monomethyl auristatin E (MMAE), a potent inhibitor of cell division .
Efficacy was evaluated in a single-arm cohort of an open-label, multicenter trial (SNDX-5613-0700, NCT04065399; AUGMENT-101) in 104 adult and pediatric participants (at least 30 days old) with relapsed or refractory (R/R) acute leukemia with a lysine methyltransferase 2A gene translocation. [3]
[7] [14] The overall response rate in these adults was 32.2%, with 2.3% having a complete response and almost 30% having a partial response. [7] The response lasted for a median of approximately five-and-a-half months. [7] The trial was conducted in Asia, Europe, and the United States. [14] Erdafitinib received an accelerated approval. [7]
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