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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]
Seattle Genetics (SGEN) and Astellas' enfortumab vedotin in combination with Merck's Keytruda proves safety in a phase I study as a first-line treatment for advanced bladder cancer. Shares up.
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.
Other side effects include redness, swelling, peeling or tenderness on the hands or feet (hand foot syndrome), constipation, stomach pain, nausea and muscle pain. [ 7 ] Erdafitinib may cause serious eye problems, including inflamed eyes, inflamed cornea (front part of the eye) and disorders of the retina, an internal part of the eye. [ 7 ]
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.
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