Modeling and Simulation Supports Label Claims for New Combination Treatment for Oncology

Certara leverages its modeling and simulation technology to facilitate regulatory approval for a targeted treatment for melanoma.

A hallmark of cancer is the abnormal activation of cellular signaling pathways. The RAS/RAF/MEK/ERK cell signaling pathway normally regulates cell proliferation, survival, migration, cell cycle regulation, and angiogenesis. Cancer cells frequently express genetic mutations that cause dysregulation of this signaling pathway. Vemurafenib is a small molecular inhibitor of B-RAF. In 2011, the FDA approved Genentech’s Zelboraf (vemurafenib) for patients with metastatic or unresectable melanoma whose tumors also express the gene mutation B-RAF V600E.

Cancer cells have a remarkable ability to become resistant to targeted therapies. Combining two or more therapies that target different parts of a cellular signaling pathway can help to address this challenge.

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