Roche's T-DM1 Early Filing Strategy Backfires As FDA Refuses To File BLA
FDA refused to file Roche's BLA for breast cancer agent trastuzumab-DM1, a conjugated version of Herceptin, for accelerated approval, the company announced Aug. 27.
FDA refused to file Roche's BLA for breast cancer agent trastuzumab-DM1, a conjugated version of Herceptin, for accelerated approval, the company announced Aug. 27.