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Adcetris Review Gives ODAC Chance To Apply Principles On Accelerated Approval

This article was originally published in The Pink Sheet Daily

Executive Summary

BLAs for Seattle Genetics' antibody-drug conjugate to treat two rare lymphomas are based on single-arm trials, and the company has begun a confirmatory study for only one indication.

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Seattle Genetics Hoping Adcetris Label Expansion Trials Can Be Confirmatory

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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Story outside: Trials in other indications can suffice as confirmatory trials for accelerated approval in the relapsed/refractory settings, FDA says during advisory committee review

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