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

Executive Summary

It hasn't been a swell summer for Roche, and now a bit of near-term pipeline news that could have put the company on a more positive trajectory has fallen flat. FDA refused to file Roche's BLA for breast cancer agent trastuzumab-DM1 (T-DM1), a conjugated version of Herceptin, for accelerated approval, the company announced Aug. 27

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