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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.
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 .
Genentech developed trastuzumab jointly with UCLA, beginning the first clinical trial with 15 women in 1992. [76] By 1996, clinical trials had expanded to over 900 women, but due to pressure from advocates based on early success, Genentech worked with the FDA to begin a lottery system allowing 100 women each quarter access to the medication ...
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]
Trial participants took venetoclax orally every day, beginning with 20 mg and increasing over a five-week period to 400 mg. [14] Results showed that 80 percent of trial participants experienced a complete or partial remission of their cancer. [14] The trial was conducted in the US, Canada, France, Germany, Poland, the United Kingdom, and Australia.
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