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Roche's T-DM1 Early Filing Strategy Backfires as FDA Refuses to File BLA
Roche's T-DM1 Early Filing Strategy Backfires as FDA Refuses to File BLA
J Merrill
20100727
2010 Aug 27
The Pink Sheet Daily
Roche's T-DM1 Early Filing Strategy Backfires as FDA Refuses to File BLA
The Pink Sheet Daily. 2010 Aug 27, J Merrill
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. Roche has already faced two significant pipeline setbacks this summer, a disappointing advisory committee review for Avastin (bevacizumab) in breast cancer and safety...