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.

Two years after FDA refused to review Roche/Genentech Inc.’s T-DM1 for accelerated approval, the company has resubmitted the application, but this time with a statistically significant overall survival advantage in hand – FDA’s gold standard for oncology approvals.

The company announced Aug. 27 that it had submitted a BLA to FDA for the antibody drug conjugate trastuzumab emtansine, a combination of the monoclonal antibody Herceptin (trastuzumab) with the...

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