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Case Study

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

Dizal (Jiangsu) Pharmaceutical developed Sunvozertinib (DZD9008), a selective EGFR tyrosine kinase inhibitor, to treat metastatic NSCLC patients with EGFR exon 20 insertion mutations—an area with limited treatment options. To secure accelerated FDA approval, Dizal partnered with Certara to address PK variability, define exposure–response (E-R) relationships, and support global regulatory submissions under tight timelines.
Certara built a population PK model for Sunvozertinib and its metabolite, performed E-R analyses linking exposure to efficacy and safety, and delivered regulatory-ready reports. This collaboration streamlined submissions, informed dose selection, and helped achieve accelerated approval, bringing a needed oral therapy to patients faster.
Therapeutic area

Oncology

The challenge

Dizal (Jiangsu) Pharmaceutical was developing Sunvozertinib (DZD9008), a selective EGFR tyrosine kinase inhibitor, to address a critical unmet need inpatients with metastatic NSCLC harboring EGFR exon20 insertion mutations.​

Existing treatments had limited benefit and high toxicity, making it vital to clearly demonstrate benefit-risk to regulators. To secure accelerated FDA approval, Dizal needed to:​

  • Build a robust understanding of Sunvozertinib and its metabolite DZ0753.​
  • Identify key sources of PK variability across diverse patients.​
  • Define exposure–response (E-R) relationships for efficacy and safety.​
  • Navigate complex global regulatory submissions under tight timelines.​

The solution

Dizal partnered with Certara to leverage expertise in pharmacometrics and regulatory strategy.​

Certara delivered comprehensive modeling and analysis, including:​

  • Joint Population PK Model: Built a semi-mechanistic, two-compartment model describing the PK of Sunvozertinib and its metabolite DZ0753 across healthy volunteers and NSCLC patients.​
  • Exposure–Response (E-R) Analysis: Linked sunvozertinib exposure to efficacy (objectiveresponse rate) and safety outcomes, including key adverse events such as diarrhea, rash, and dose-limiting toxicities.​
  • Regulatory-Ready Deliverables: Provided validated reports and simulations quantifying variability across patient factors like age, bodyweight, and organ function to support global submissions.​

The impact

Through this collaboration, Dizal successfully:​

  • Justified the benefit-risk profile of Sunvozertinib, supporting its selection as the optimal therapy for patients with EGFR exon20 insertion mutations.​
  • Streamlined regulatory submissions with clear, validated population PK and E-R analyses.​
  • Enabled data-driven dose selection for current and future studies, reducing the need for unnecessary clinical trials.​
  • Achieved accelerated FDA approval, bringing a life-changing oral therapy to patients faster than traditional development timelines.

“Sunvozertinib received accelerated FDA approval for metastatic NSCLC with EGFR exon 20 insertion mutations — a milestone achieved through exceptional collaboration.”

Kan Chen, Vice President of Clinical Pharmacology, Dizal (Jiangsu) Pharmaceutical

Contact Certara


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