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.

Melanoma is a type of skin cancer. In advanced melanoma, the cancer has spread to other parts of the body through the blood or lymphatic system. Advanced melanoma is also known as stage 4 melanoma or metastatic melanoma. Individuals with advanced melanoma generally experience weight loss, loss of appetite, and extreme fatigue, but these symptoms change depending on where the melanoma has spread to in the body.

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