Roche's T-DM1 Early Filing Strategy Backfires As FDA Refuses To File BLA
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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Randomization Required: Liver Signal Necessitated Kadcyla Trial With Control Arm
A pivotal trial with a control arm was necessary to evaluate a hepatotoxicity signal with Genentech’s Kadcyla, helping to derail a bid for accelerated approval based on a single-arm Phase II trial. Genentech’s strategy of running trials in different lines of treatment concurrently enabled a quick strategy shift as an ongoing controlled Phase III trial in another line was amended to meet FDA’s regulatory requests.
Redefining Accelerated Approval Criteria Would Expand Pathway’s Use, Panel Says
Expanding the definition of “unmet medical need” and adopting a narrow, molecularly targeted approach to determining the existence of “available therapies” would enable use of the approval pathway in earlier treatment settings, a group of stakeholders tells a cancer research conference.
Genentech Resubmits T-DM1 To FDA, This Time With An Overall Survival Benefit
The antibody drug conjugate showed a significant overall survival benefit in HER2-positive metastatic breast cancer in the EMILIA trial, the company announced.