Case Study: Dizal Pharma Achieves FDA Approval for Sunvozertinib with Certara

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

The customer, Dizal Pharma, faced the challenge of securing accelerated FDA approval for its new lung cancer drug, Sunvozertinib. They needed to address complex pharmacokinetic variability and define exposure-response relationships to demonstrate the drug's benefit-risk profile to regulators. To overcome this, Dizal partnered with the vendor Certara to leverage its pharmacometrics and Modeling and Simulation services.

Certara implemented a comprehensive solution, building a population PK model and performing exposure-response analyses for both efficacy and safety. This provided the data-driven evidence needed for regulatory submissions and dose selection. As a result of this collaboration, Dizal successfully streamlined its global submissions and achieved accelerated FDA approval for Sunvozertinib, bringing this critical oral therapy to patients faster than traditional development timelines would allow.

Dizal Pharma

Kan Chen

Vice President of Clinical Pharmacology