How Certara Enabled Fruquintinib FDA Approval for Metastatic Colorectal Cancer

HUTCHMED was preparing a U.S. New Drug Application for FRUZAQLA® (fruquintinib) for metastatic colorectal cancer; though already approved in China in 2023, U.S. approval required extensive clinical pharmacology support and pharmacometrics modeling on a tight timeline, over a three-year project complicated by data variability across studies, complex exposure-response analysis, and stringent QT-prolongation assessment requirements. Certara provided population PK modeling, safety/efficacy exposure-response analysis, concentration-QTc cardiac safety assessment, non-compartmental analysis, and regulatory medical writing. This work led to successful FDA approval in 2023, met submission deadlines despite the analytical complexity, and established a "parallel report-writing approach" that accelerated later regulatory submissions and minimized delays in critical filings; no specific numerical timeline or cost figures are given.

The customer is anonymised in Certara’s own case study — not withheld by us.

Certara is a biosimulation software company (Simcyp, Phoenix) whose PK/PD and QSP models predict drug behavior in the body; the FDA itself licenses Certara's software to review sponsor submissions.

This sits in the Build stage of the AI use-case lifecycle: Named examples from the foundation-model labs and platforms pharma teams use to actually construct, train and generate the model or application.