Roche slammed with FDA partial hold on Tecentriq-combo trial
Based on emerging safety data from clinical trials evaluating pembrolizumab in combination with either lenalidomide or pomalidomide in multiple myeloma, the US Food and Drug Administration has requested that a Phase Ib and a Phase Ib/II Tecentriq (atezolizumab) study be placed on partial clinical hold.
Tecentriq’s developers, Swiss pharma major Roche (ROG: SIX) and its subsidiary Genentech, say they remain committed to patient safety and will continue to work closely with the FDA.
“It is our understanding that the FDA is evaluating all ongoing blood cancer trials investigating an anti-PD1/PDL1 medicine in combination with an immunomodulatory medicine to determine if it is a class-wide (anti-PD1/PDL1) concern in multiple myeloma/blood cancers or a specific concern with certain combinations with immunomodulatory medicines,” they stated.
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