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Roche's T-DM1 Early Filing Strategy Backfires As FDA Refuses To File BLA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA issued a refusal to file letter for Roche's BLA for trastuzumab-DM1 (T-DM1) for accelerated approval because all the available treatment choices approved for metastatic breast cancer had not been exhausted in the study population, Roche said Aug. 27

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