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Seattle Genetics Hoping Adcetris Label Expansion Trials Can Be Confirmatory

Executive Summary

Over the next six weeks Seattle Genetics intends to negotiate with FDA over its plans for confirmatory trials to support accelerated approval of Adcetris (brentuximab vedotin) – which the company hopes to accomplish using studies already planned as further development of the antibody-drug conjugate.

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Isis banks on milestones from partners, Onyx rakes in higher-than-expected revenues from Kyprolis, Seattle Genetics announces trial delays, and other news from biopharma’s first quarter.

Seattle Genetics Commits To Simultaneous Confirmatory Trials For Adcetris

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Adcetris Review Adds Some Clarity To Principles For Accelerated Approval

Sponsors seeking insight into when a single-arm trial will be deemed acceptable support for accelerated approval by FDA and its Oncologic Drugs Advisory Committee can look to the recent review of Seattle Genetics’ Adcetris (brentuximab) for clues.

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