Certara & Dizal Partner to Fast-Track FDA Approval of Sunvozertinib for Lung Cancer

Dizal Pharmaceutical developed sunvozertinib (DZD9008) for metastatic NSCLC patients with EGFR exon 20 insertion mutations, a population where existing treatments offered limited benefit and high toxicity, and needed to characterize pharmacokinetic variability and benefit-risk under tight accelerated-approval timelines. Certara built a semi-mechanistic two-compartment PK model of sunvozertinib and its metabolite DZ0753 across healthy volunteers and NSCLC patients, ran exposure-response analyses linking exposure to efficacy and safety events like diarrhea and rash, and delivered regulatory-ready reports quantifying variability across patient factors. The partnership contributed to accelerated FDA approval, streamlined regulatory submissions, supported data-driven dose selection, and justified the drug's benefit-risk profile for its target population.

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.