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Randomization Required: Liver Signal Necessitated Kadcyla Trial With Control Arm

 
• By Bridget Silverman

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.

Genentech Inc.’s attempt to bring its antibody-drug conjugate Kadcyla (ado-trastuzumab emtansine) to market early based on a single-arm Phase II trial via accelerated approval was torpedoed by a fatal case of hepatotoxicity, FDA review documents for the metastatic HER2-positive breast cancer therapy indicate.

The antibody-drug conjugate combining trastuzumab (Genentech’s Herceptin) with the cytotoxic maytansine, known as DM1, was being deemed a new molecular entity, and FDA said a well-controlled trial was needed to...

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