'Rapid approval policy benefits' presentation slideshows

Four Special Channels for FDA to Review Drugs

Recently, the FDA awarded the patent-based enfortumab vedotin antibody-conjugated drug developed jointly by Seattle Genetics and its partner Astellas. The drug is currently in a phase II study of a key metastatic transitional cell carcinoma. This is undoubtedly a good news for Seattle Genetics. They have also marked the project with a "breakthrough therapy" label. After the first commercial product, Adcetris, this is the company's most promising ADC drug. Enfortumab vedotin consists of an anti-Nectin-4 monoclonal antibody and Seattle's own synthetic cytotoxin monomethyl auristatin E (MMAE), which is the first ADC drug to target solid tumor Nectin-4, targeting bladder cancer.

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