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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]
In International Nonproprietary Names for MMAE-MAB-conjugates, the name vedotin refers to MMAE plus its linking structure to the antibody. [1] It is a potent antimitotic drug derived from peptides occurring in marine shell-less mollusc Dolabella auricularia called dolastatins which show potent activity in preclinical studies, both in vitro and ...
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]
Efficacy was established based on the rate of complete remission (CR) and CR duration. [ 18 ] Study M14-358 (NCT02203773) was a non-randomized, open-label clinical trial of venetoclax in combination with azacitidine (n=67) or decitabine (n=13) in newly diagnosed participants with AML. [ 18 ]
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