PBPK Assists with DDI Prediction Without a Rifampin Study for Cobimetinib

To build the model, the one itraconazole study, along with mass balance, human PK, and in vitro data was used to predict the effects of those inducers and inform the final drug label. By leveraging the Simcyp Simulator and its oncology population file, the effects of CYP3A4 modulators on cobimetinib PK in healthy and cancer patients were predicted, with only one clinical study.

The label language clearly indicates that the final label was informed by simulations alone. This is a huge benefit in that the sponsor was able to avoid having to conduct a specific clinical trial to evaluate the effects of rifampin.

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